Effect of Tadalafil on Insulin Secretion and Insulin Sensitivity in Obese Men.
Sponsor
University of Guadalajara (Other)
Overall Status
Completed
CT.gov ID
NCT02595684
Collaborator
(none)
18
1
2
3
6
Study Details
Study Description
Brief Summary
Obesity is a chronic disease of multifactorial etiology that develops from the interaction of the influence of nutritive , metabolic , cellular and molecular psychological factors.
Tadalafil is Is a drug inhibiting the enzyme phosphodiesterase-5 (PDE-5), responsible for inactivating the vasodilator nitric oxide. USING paragraph was mainly treat erectile dysfunction, and recently approved for the treatment of pulmonary hypertension , it is innovative because of its longer life means, provides efficacy after 36 hours and the highest selectivity.
The aim of this study is to evaluate the effect of tadalafil on insulin sensitivity and insulin secretion in obese men.
The investigators hypothesis is that the administration of tadalafil improve the insulin sensitivity and insulin secretion in obese men.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
A randomized, double-blind, placebo-controlled clinical trial in 18 men aged between 30 and 50 years with obesity (BMI 30-39.9) according to the World Health Organization (WHO) criteria without treatment.
They will be assigned randomly in two groups of 9 patients, each to receive 5 mg of tadalafil or placebo every day at night during 28 days.
There will be evaluated Insulin secretion, both first phase of insulin secretion by Stumvoll Inex as well as Total Insulin Secretion by Area Under the Curve of glucose and insulin and Insulinogenic Index, and Insulin sensitivity by Matsuda index.
Waist circumference, glucose and insulin levels, lipid profile and blood pressure are going to be load will be evaluated before and after intervention in both groups.
Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2, will be used for differences inter-group Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. Will be considered statistical significance p ≤0.05.
This protocol was approved by a local Ethics Committee and written informed consent will be obtained from all volunteers.
Study Design
Study Type:
Interventional
Actual Enrollment
:
18 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Tadalafil on Insulin Secretion and Insulin Sensitivity in Obese Men.
Actual Study Start Date
:
Aug 1, 2015
Actual Primary Completion Date
:
Nov 1, 2015
Actual Study Completion Date
:
Nov 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tadalafil Tadalafil capsules |
Drug: Tadalafil
Tadalafil capsules: 5 mg, one per day, at night, during 28 days.
Other Names:
|
| Placebo Comparator: Placebo Calcined magnesia capsules |
Drug: Placebo
Calcined magnesia capsules: one per day, at night, during 28 days.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Fasting Glucose [Fasting glucose at Day 28]
Fasting glucose will be evaluated at baseline and Day 28 with enzymatic-colorimetric.
- Postprandial Glucose [Postprandial glucose at Day 28]
Postprandial glucose will be evaluated at baseline and Day 28 after a oral glucose. tolerance test with enzymatic-colorimetric techniques.
- First Phase of Insulin Secretion [First phase of insulin secretion at Day 28]
First phase of insulin secretion will be calculated at baseline and Day 28 with Stumvoll Index. Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis. First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the first phase of insulin secretion
- Total Insulin Secretion [Total insulin secretion at Day 28]
Total insulin secretion will be calculated at baseline and Day 28 with Insulinogenic Index. The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus. Total insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion
- Insulin Sensitivity [Insulin sensitivity at Day 28]
Insulin sensitivity will be calculated at baseline and Day 28 with Matsuda Index. Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity
- Area Under the Curve (AUC) Glucose [AUC at Day 28]
Area under the curve of glucose measured at baseline and Day 28. The area under the curve (AUC) of glucose, (0.5 * glucose (G) 0´ + (G 30´+G 60´ + G 90´) + 0.5 * G 120´) * 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperglycemia.
- Area Under the Curve (AUC) Insulin [AUC at Day 28]
Area under the curve of insulin measured at baseline and Day 28. The Area Under the Curve (AUC) of insulin, (0.5 * Insulin (I) 0´ + (I 30´+I 60´ + I 90´) + 0.5 * I 120´) * 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperinsulinemia.
Secondary Outcome Measures
- Body Weight [Body Weight at Day 28]
The body weight will be measured at baseline and Day 28 by Electrical bioimpedance.
- Body Mass Index [Body Mass Index at Day 28]
The Body Mass Index will be measured at baseline and Day 28 by Quetelet Index Formula.
- Waist Circumference [Waist circumference at Day 28]
Waist circumference was evaluated at baseline and at Day 28 with a flexible tape.
- Triglycerides [Triglycerides levels at Day 28]
Triglycerides levels will be evaluated at baseline and Day 28 with enzymatic-colorimetric techniques.
- Total Cholesterol [Total cholesterol levels at Day 28]
Total cholesterol levels will be evaluated at baseline and Day 28 with enzymatic-colorimetric techniques.
- High Density Lipoprotein Cholesterol (HDL-c) [HDL-c levels at Day 28]
High density lipoprotein cholesterol (HDL-c) levels will be evaluated at baseline and Day 28 with enzymatic-colorimetric techniques.
- Low Density Lipoprotein Cholesterol (LDL-c) [LDL-c levels at Day 28]
Low density lipoprotein cholesterol (LDL-c) levels will be evaluated at baseline and Day 28 with Friedewald formula.
- Systolic Blood Pressure [Systolic Blood Pressure at Day 28]
The systolic blood pressure was evaluated at baseline and Day 28 with a digital sphygmomanometer.
- Diastolic Blood Pressure [Diastolic Blood Pressure at Day 28]
- Body Fat [Body fat at Day 28]
The body fat will be measured at baseline and Day 28 by Electrical bioimpedance in %
Eligibility Criteria
Criteria
Ages Eligible for Study:
30 Years
to 50 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Men
-
Age: 30-50 years
-
BMI: 30 to 39.9 kg/m²
-
No Pharmacotherapy during the last 3 months
-
Signature Consent under Information
Exclusion Criteria:
-
Cholesterol: ≥ 240 mg / dl
-
Triglycerides: ≥ 400 mg / dl
-
Fasting glucose: ≥ 126 mg / dl
-
Diabetes mellitus.
-
Hypertension
-
Patients with renal, liver and / or thyroid disease
-
Consumption of drugs with known effects on glucose or insulin metabolism.
-
Use of cigar and / or drugs
-
Hypersensitivity to tadalafil
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Instituto de Terapéutica Experimental y Clínica | Guadalajara | Jalisco | Mexico | 44140 |
Sponsors and Collaborators
- University of Guadalajara
Investigators
- Principal Investigator: Manuel González-Ortíz, PhD, University of Guadalajara
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Manuel González Ortiz,
Senior Researcher,
University of Guadalajara
ClinicalTrials.gov Identifier:
NCT02595684
Other Study ID Numbers:
- TADALAFIL-OB
First Posted:
Nov 3, 2015
Last Update Posted:
Oct 9, 2020
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Manuel González Ortiz,
Senior Researcher,
University of Guadalajara
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Tadalafil | Placebo |
|---|---|---|
| Arm/Group Description | Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days. | Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days. |
| Period Title: Overall Study | ||
| STARTED | 9 | 9 |
| COMPLETED | 9 | 9 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Tadalafil | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days. | Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days. | Total of all reporting groups |
| Overall Participants | 9 | 9 | 18 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
9
100%
|
9
100%
|
18
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
40.2
(7.9)
|
38.4
(6.4)
|
39.3
(7.2)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
0
0%
|
0
0%
|
0
0%
|
| Male |
9
100%
|
9
100%
|
18
100%
|
| Region of Enrollment (participants) [Number] | |||
| Mexico |
9
100%
|
9
100%
|
18
100%
|
| Fasting Glucose (mmol/L) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mmol/L] |
4.9
(0.4)
|
4.8
(0.7)
|
4.85
(0.55)
|
| Postprandial Glucose (mmol/L) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mmol/L] |
6.6
(1.9)
|
5.4
(1.3)
|
6
(1.6)
|
| First Phase of Insulin (index) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [index] |
1332
(487)
|
1135
(598)
|
1233.5
(542.5)
|
| Total Insulin Secretion (index) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [index] |
0.82
(0.45)
|
0.45
(0.21)
|
0.64
(0.33)
|
| Insulin Sensitivity (index) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [index] |
4.6
(1.2)
|
5.0
(2.9)
|
4.8
(2.05)
|
| Body Weight (kg) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg] |
98.2
(14.4)
|
98.9
(10.4)
|
98.55
(12.4)
|
| Body Mass Index (kg/m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg/m^2] |
33.4
(3.3)
|
33.3
(3.7)
|
33.35
(3.5)
|
| Waist Circumference (cm) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [cm] |
111
(9)
|
110
(13)
|
110.5
(11)
|
| Triglycerides (mmol/L) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mmol/L] |
1.9
(1.0)
|
1.9
(0.9)
|
1.9
(0.95)
|
| Total Cholesterol (mmol/L) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mmol/L] |
4.6
(1.2)
|
4.5
(0.8)
|
4.55
(1.0)
|
| High Density LIpoprotein cholesterol (HDL-c) (mmol/L) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mmol/L] |
1.1
(0.3)
|
1.0
(0.2)
|
1.05
(0.25)
|
| Low density lipoprotein cholesterol (LDL-c) (mmol/L) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mmol/L] |
2.7
(0.7)
|
2.6
(0.5)
|
2.65
(0.6)
|
| Systolic Blood Pressure (mmHg) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mmHg] |
120
(8)
|
120
(10)
|
120
(9)
|
| Diastolic Blood Pressure (mmHg) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mmHg] |
81
(7)
|
76
(8)
|
78.5
(7.5)
|
| Body Fat (%) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [%] |
33.3
(6.6)
|
31.0
(2.8)
|
32.1
(4.8)
|
| Area under the curve (AUC) glucose (mmol*h/L) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mmol*h/L] |
508
(87)
|
513
(146)
|
511
(117)
|
| Area under the curve (AUC) insulin (pmol*h/L) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [pmol*h/L] |
285
(114)
|
326
(181)
|
307
(146)
|
Outcome Measures
| Title | Fasting Glucose |
|---|---|
| Description | Fasting glucose will be evaluated at baseline and Day 28 with enzymatic-colorimetric. |
| Time Frame | Fasting glucose at Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Tadalafil | Placebo |
|---|---|---|
| Arm/Group Description | Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days. | Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days. |
| Measure Participants | 9 | 9 |
| Mean (Standard Deviation) [mmol/L] |
4.8
(0.6)
|
5.0
(0.5)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.327 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tadalafil |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.635 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Postprandial Glucose |
|---|---|
| Description | Postprandial glucose will be evaluated at baseline and Day 28 after a oral glucose. tolerance test with enzymatic-colorimetric techniques. |
| Time Frame | Postprandial glucose at Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Tadalafil | Placebo |
|---|---|---|
| Arm/Group Description | Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days. | Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days. |
| Measure Participants | 9 | 9 |
| Mean (Standard Deviation) [mmol/L] |
6.3
(2.1)
|
6.5
(2.3)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.380 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tadalafil |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.441 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | First Phase of Insulin Secretion |
|---|---|
| Description | First phase of insulin secretion will be calculated at baseline and Day 28 with Stumvoll Index. Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis. First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the first phase of insulin secretion |
| Time Frame | First phase of insulin secretion at Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Tadalafil | Placebo |
|---|---|---|
| Arm/Group Description | Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days. | Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days. |
| Measure Participants | 9 | 9 |
| Mean (Standard Deviation) [index] |
1602
(800)
|
1194
(490)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0515 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tadalafil |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.953 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Total Insulin Secretion |
|---|---|
| Description | Total insulin secretion will be calculated at baseline and Day 28 with Insulinogenic Index. The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus. Total insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion |
| Time Frame | Total insulin secretion at Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Tadalafil | Placebo |
|---|---|---|
| Arm/Group Description | Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days. | Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days. |
| Measure Participants | 9 | 9 |
| Mean (Standard Deviation) [index] |
0.52
(0.29)
|
0.61
(0.27)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.314 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tadalafil |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.594 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Insulin Sensitivity |
|---|---|
| Description | Insulin sensitivity will be calculated at baseline and Day 28 with Matsuda Index. Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity |
| Time Frame | Insulin sensitivity at Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Tadalafil | Placebo |
|---|---|---|
| Arm/Group Description | Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days. | Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days. |
| Measure Participants | 9 | 9 |
| Mean (Standard Deviation) [index] |
4.8
(3.1)
|
4.9
(2.5)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.767 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tadalafil |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.779 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Area Under the Curve (AUC) Glucose |
|---|---|
| Description | Area under the curve of glucose measured at baseline and Day 28. The area under the curve (AUC) of glucose, (0.5 * glucose (G) 0´ + (G 30´+G 60´ + G 90´) + 0.5 * G 120´) * 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperglycemia. |
| Time Frame | AUC at Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Tadalafil | Placebo |
|---|---|---|
| Arm/Group Description | Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days. | Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days. |
| Measure Participants | 9 | 9 |
| Mean (Standard Deviation) [mmol*h/L] |
503
(137)
|
522
(135)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.859 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tadalafil |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.767 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Area Under the Curve (AUC) Insulin |
|---|---|
| Description | Area under the curve of insulin measured at baseline and Day 28. The Area Under the Curve (AUC) of insulin, (0.5 * Insulin (I) 0´ + (I 30´+I 60´ + I 90´) + 0.5 * I 120´) * 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperinsulinemia. |
| Time Frame | AUC at Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Tadalafil | Placebo |
|---|---|---|
| Arm/Group Description | Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days. | Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days. |
| Measure Participants | 9 | 9 |
| Mean (Standard Deviation) [pmol*h/L] |
291
(160)
|
262
(110)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.374 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tadalafil |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.953 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Body Weight |
|---|---|
| Description | The body weight will be measured at baseline and Day 28 by Electrical bioimpedance. |
| Time Frame | Body Weight at Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Tadalafil | Placebo |
|---|---|---|
| Arm/Group Description | Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days. | Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days. |
| Measure Participants | 9 | 9 |
| Mean (Standard Deviation) [kg] |
99.1
(14.4)
|
98.2
(9.0)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.594 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tadalafil |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.085 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Body Mass Index |
|---|---|
| Description | The Body Mass Index will be measured at baseline and Day 28 by Quetelet Index Formula. |
| Time Frame | Body Mass Index at Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Tadalafil | Placebo |
|---|---|---|
| Arm/Group Description | Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days. | Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days. |
| Measure Participants | 9 | 9 |
| Mean (Standard Deviation) [kg/m^2] |
33.7
(3.3)
|
33.1
(3.2)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.594 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tadalafil |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.086 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Waist Circumference |
|---|---|
| Description | Waist circumference was evaluated at baseline and at Day 28 with a flexible tape. |
| Time Frame | Waist circumference at Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Tadalafil | Placebo |
|---|---|---|
| Arm/Group Description | Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days. | Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days. |
| Measure Participants | 9 | 9 |
| Mean (Standard Deviation) [cm] |
112
(9)
|
112
(13)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.285 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tadalafil |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.854 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Triglycerides |
|---|---|
| Description | Triglycerides levels will be evaluated at baseline and Day 28 with enzymatic-colorimetric techniques. |
| Time Frame | Triglycerides levels at Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Tadalafil | Placebo |
|---|---|---|
| Arm/Group Description | Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days. | Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days. |
| Measure Participants | 9 | 9 |
| Mean (Standard Deviation) [mmol/L] |
2.3
(1.9)
|
2.4
(2.0)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.374 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tadalafil |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.263 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Total Cholesterol |
|---|---|
| Description | Total cholesterol levels will be evaluated at baseline and Day 28 with enzymatic-colorimetric techniques. |
| Time Frame | Total cholesterol levels at Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Tadalafil | Placebo |
|---|---|---|
| Arm/Group Description | Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days. | Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days. |
| Measure Participants | 9 | 9 |
| Mean (Standard Deviation) [mmol/L] |
4.4
(0.9)
|
4.3
(1.3)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.859 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tadalafil |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.374 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | High Density Lipoprotein Cholesterol (HDL-c) |
|---|---|
| Description | High density lipoprotein cholesterol (HDL-c) levels will be evaluated at baseline and Day 28 with enzymatic-colorimetric techniques. |
| Time Frame | HDL-c levels at Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Tadalafil | Placebo |
|---|---|---|
| Arm/Group Description | Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days. | Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days. |
| Measure Participants | 9 | 9 |
| Mean (Standard Deviation) [mmol/L] |
1.1
(0.2)
|
1.1
(0.2)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.722 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tadalafil |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.953 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Low Density Lipoprotein Cholesterol (LDL-c) |
|---|---|
| Description | Low density lipoprotein cholesterol (LDL-c) levels will be evaluated at baseline and Day 28 with Friedewald formula. |
| Time Frame | LDL-c levels at Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Tadalafil | Placebo |
|---|---|---|
| Arm/Group Description | Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days. | Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days. |
| Measure Participants | 9 | 9 |
| Mean (Standard Deviation) [mmol/L] |
2.3
(0.5)
|
2.2
(0.8)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.260 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tadalafil |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.314 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Systolic Blood Pressure |
|---|---|
| Description | The systolic blood pressure was evaluated at baseline and Day 28 with a digital sphygmomanometer. |
| Time Frame | Systolic Blood Pressure at Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Tadalafil | Placebo |
|---|---|---|
| Arm/Group Description | Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days. | Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days. |
| Measure Participants | 9 | 9 |
| Mean (Standard Deviation) [mmHg] |
120
(6)
|
115
(8)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.058 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tadalafil |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.952 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Diastolic Blood Pressure |
|---|---|
| Description | |
| Time Frame | Diastolic Blood Pressure at Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Tadalafil | Placebo |
|---|---|---|
| Arm/Group Description | Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days. | Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days. |
| Measure Participants | 9 | 9 |
| Mean (Standard Deviation) [mmHg] |
77
(6)
|
73
(7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.128 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tadalafil |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.108 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Body Fat |
|---|---|
| Description | The body fat will be measured at baseline and Day 28 by Electrical bioimpedance in % |
| Time Frame | Body fat at Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Tadalafil | Placebo |
|---|---|---|
| Arm/Group Description | Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days. | Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days. |
| Measure Participants | 9 | 9 |
| Mean (Standard Deviation) [percentage of fat] |
33.7
(3.3)
|
33.1
(3.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.092 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tadalafil |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.374 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Adverse Events
| Time Frame | Throughout the study, an average of 28 days | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Tadalafil | Placebo | ||
| Arm/Group Description | Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days. | Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days. | ||
All Cause Mortality |
||||
| Tadalafil | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | 0/9 (0%) | ||
Serious Adverse Events |
||||
| Tadalafil | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | 0/9 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Tadalafil | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/9 (33.3%) | 4/9 (44.4%) | ||
| Gastrointestinal disorders | ||||
| Dyspepsia | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 |
| Infections and infestations | ||||
| Chills | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Muscle pain | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 |
| Nervous system disorders | ||||
| Headache | 1/9 (11.1%) | 1 | 2/9 (22.2%) | 2 |
| Insomnia | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 |
| Renal and urinary disorders | ||||
| Edema | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | DR. MANUEL GONZALEZ ORTIZ |
|---|---|
| Organization | INSTITUTO DE TERAPEUTICA EXPERIMENTAL Y CLINICA, UNIVERSITY OF GUADALAJARA |
| Phone | +52 3310585200 ext 34212 |
| uiec@prodigy.net.mx |
Responsible Party:
Manuel González Ortiz,
Senior Researcher,
University of Guadalajara
ClinicalTrials.gov Identifier:
NCT02595684
Other Study ID Numbers:
- TADALAFIL-OB
First Posted:
Nov 3, 2015
Last Update Posted:
Oct 9, 2020
Last Verified:
Sep 1, 2020