Effect of Momordica Charantia Administration on Type 2 Diabetes Mellitus, Insulin Sensitivity and Insulin Secretion

• Sponsor: University of Guadalajara (Other)
• Overall Status: Completed
• CT.gov ID: NCT02397447
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 32
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The hypoglycemic effect of Momordica Charantia has been evaluated in clinical trials in patients with type 2 diabetes mellitus. Important reductions in fasting plasma glucose, glycated hemoglobin (A1C), and fructosamine were observed. It is unknown whether this improvement is due to an improvement in insulin sensitivity and insulin secretion. The purpose of this study is to evaluate the effect of the administration of Momordica Charantia on insulin sensitivity and insulin secretion in patients with type 2 diabetes mellitus.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Type 2	Drug: Momordica charantia; Drug: Placebo	Phase 2

Detailed Description

A randomized, double-blind, placebo controlled clinical trial is carried out in 24 patients with diagnosis of diabetes mellitus type 2 according to the criteria of the American Diabetes Association. Patients are assigned to two different arms: one group receives Momordica Charantia, 2 capsules with 500 mg twice daily before breakfast and dinner for 90 days or placebo, under the same scheme of treatment.

An oral glucose tolerance test is performed before and after the intervention. Matsuda index, Stumvoll index and Insulinogenic index are calculated to assess insulin sensitivity and insulin secretion.

Other clinical and laboratory parameters that are evaluated include: Body weight, body mass index, waist circumference, blood pressure, body fat percentage, fasting plasma glucose, A1C, creatinine, lipid profile and liver transaminases.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effect of Momordica Charantia Administration on Insulin Sensitivity and Insulin Secretion in Patients With Type 2 Diabetes Mellitus, Without Pharmacological Treatment
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Momordica charantia Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days	Drug: Momordica charantia; Momordica Charantia: 2000 mg per day for three months; Other Names: Bitter gourd, karela, balsam-pear
Placebo Comparator: Placebo Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days	Drug: Placebo; Placebo: 2000 mg per day for three months; Other Names: Calcined magnesia

Outcome Measures

Primary Outcome Measures

1. Total and First Phase of Insulin Secretion (Insulinogenic Index and Stumvoll Index) After 90 Days [90 days]

   Total insulin secretion and first phase of insulin secretion were estimated at baseline and after 90 days using the insulinogenic index (ΔABC insulin / ΔABC glucose) and the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), respectively

2. Insulin Sensitivity (Matsuda Index) After 90 Days [90 days]

   Insulin sensitivity was calculated at baseline and after 90 days with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]

Secondary Outcome Measures

1. Fasting Serum Glucose (FSG) After 90 Days [90 days]

   The glucose oxidase technique (Beckman Instruments, Inc., Brea, CA, USA) was used to determine fasting serum glucose at baseline and after 90 days with an intra- and interassay coefficient of variation of<1

2. A1C After 90 Days [90 days]

   A liquid chromatography method was used to evaluate A1C at baseline and after 90 days (Bio-Rad Laboratories, Hercules, CA, USA) with an intra and inter assay coefficient of variation of 0.4% and 1.6%, respectively

3. Total Cholesterol After 90 Days [90 days]

   The blood sample for the determination of total cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method

4. Triglycerides After 90 Days [90 days]

   The blood sample for the determination of triglycerides was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method

5. High Density Lipoprotein Cholesterol (HDL-c) After 90 Days [90 days]

   The blood sample for the determination of high density lipoprotein cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method

6. Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days [90 days]

   The blood sample for the determination of low density lipoprotein cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method

7. Very Low Density Lipoprotein After 90 Days [90 days]

   The blood sample for the determination of VLDL was taken after an overnight fast and was calculated at baseline and after 90 days as triglycerides/5

8. Alanine Aminotransferase (ALT) After 90 Days [90 days]

   The blood sample for the determination of ALT was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method

9. Aspartate Aminotransferase (AST) After 90 Days [90 days]

   The blood sample for the determination of AST was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method

10. Creatinine After 90 Days [90 days]

    The blood sample for the determination of creatinine was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method

11. Systolic Blood Pressure After 90 Days [90 days]

    The systolic blood pressure was evaluated at baseline and after 90 days with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of SBP. The value was expressed on mmHg

12. Diastolic Blood Pressure After 90 Days [90 days]

    The diastolic blood pressure was evaluated at baseline and after 90 days with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of DBP. The value was expressed on mmHg

13. Body Weight (BW) After 90 Days [90 days]

    The body weight was evaluated at baseline and after 90 days after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal.

14. Body Mass Index (BMI) After 90 Days [90 days]

    The BMI was calculated at baseline and after 90 days by the square of the body height, and is universally expressed in units of kg/m^2, resulting from mass in kilograms and height in metres

15. Fat Mass After 90 Days [90 days]

    Fat mass was measured at baseline and after 90 days with an electric bioimpedance scale (Model TBF-300 A; Tanita Corporation of America Inc., Arlington Heights, IL)

16. Waist Circumference (WC) After 90 Days [90 days]

    The waist circumference was evaluated at baseline and after 90 days after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters

17. 2-h Serum Glucose After 90 Days [90 days]

    The glucose oxidase technique (Beckman Instruments, Inc., Brea, CA, USA) was used to determine serum glucose at baseline and after 90 days with an intra- and interassay coefficient of variation of<1%

18. AUC-glucose After 90 Days [90 days]

    The polygonal formula was used to calculate area under the curve (AUC) of glucose at baseline and after 90 days

19. AUC-insulin After 90 Days [90 days]

    The polygonal formula was used to calculate area under the curve (AUC) of insulin at baseline and after 90 days

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of diabetes mellitus type 2 according to the criteria of the American Diabetes Association (<5 years), without pharmacological treatment (oral antidiabetic drugs or insulin) at least for three months before entering the study

• Fasting glucose: <210 mg/dl

• A1C: 7-9%

• Body mass index: 25-34.9 kg/m2

• Body weight without variations above or under 5% in the last three months before entering the study

• Women in childbearing years must have a contraceptive method

• Letter of consent and release signed by each patient

Exclusion Criteria:

• Pregnant or suspected pregnant women

• Woman breastfeeding

• Medications known to affect metabolism of glucose and insulin

• Personal history of liver or renal disease

• Hypertension, thyroid or cardiovascular disease decompensated

• Total cholesterol >= 240mg/dl, triglycerides >=400mg/dl, glomerular filtration rate <=60ml/min or liver transaminases >=2.5 the upper normal limit

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara	Guadalajara	Jalisco	Mexico	44340

Sponsors and Collaborators

• University of Guadalajara

Investigators

• Principal Investigator: Esperanza Martínez Abundis, PhD Science, Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Esperanza Martínez-Abundis, PhD. Esperanza Martínez-Abundis, University of Guadalajara
• ClinicalTrials.gov Identifier: NCT02397447
• Other Study ID Numbers: MCHDM2
• First Posted: Mar 25, 2015
• Last Update Posted: Oct 22, 2020
• Last Verified: Sep 1, 2020

• Keywords provided by Esperanza Martínez-Abundis, PhD. Esperanza Martínez-Abundis, University of Guadalajara: Momordica Charantia; Insulin secretion; Insulin sensitivity
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Hypersensitivity

Study Results

Participant Flow

Arm/Group Title	Momordica Charantia	Placebo
Arm/Group Description	Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months	Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months
Period Title: Overall Study
STARTED	12	12
COMPLETED	10	10
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Momordica Charantia	Placebo	Total
Arm/Group Description	Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months	Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months	Total of all reporting groups
Overall Participants	12	12	24
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.1 (7.3)	47 (7.4)	48.6 (7.4)
Sex: Female, Male (Count of Participants)
Female	7 58.3%	9 75%	16 66.7%
Male	5 41.7%	3 25%	8 33.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	12 100%	12 100%	24 100%
Not Hispanic or Latino	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Mexico	12 100%	12 100%	24 100%
Body weight (BW) (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	79.4 (9.2)	73.6 (11.1)	76.5 (10.4)
Body mass index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	29.1 (2.4)	28.8 (3.9)	28.9 (3.2)
Fat mass (body fat percentage) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [body fat percentage]	36.7 (7.8)	35.2 (8.1)	36.0 (7.8)
Waist circumference (WC) (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	106 (12)	97 (11)	101.9 (12.1)
Systolic blood pressure (SBP) (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	119.5 (8.9)	116.5 (10.8)	118.0 (9.8)
Diastolic blood pressure (DBP) (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	75 (4.7)	74.2 (5.5)	74.6 (5.0)
A1C (percentage) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage]	7.8 (0.8)	7.6 (0.6)	7.7 (0.7)
Fasting serum glucose (FSG) (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	8.2 (1.4)	7.1 (1.9)	7.6 (1.7)
2-h serum glucose (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	17.1 (3.7)	14.9 (4.7)	16.0 (4.3)
AUC-glucose (mmol/L/min) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L/min]	1840 (295)	1670 (380)	1754.1 (344.0)
AUC-insulin (pmol/L/min) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pmol/L/min]	56562 (36078)	41334 (22356)	48951 (30369)
Insulinogenic index (total insulin secretion) (index) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [index]	0.29 (0.18)	0.23 (0.14)	0.26 (0.16)
Stumvoll index (first phase of insulin secretion) (index) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [index]	557.8 (645.6)	419.3 (769.1)	488.6 (698.0)
Matsuda index (insulin sensitivity) (index) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [index]	2.4 (1.4)	3.8 (4.6)	3.1 (3.4)
Total cholesterol (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	4.89 (0.73)	4.41 (0.75)	4.65 (0.76)
Triglycerides (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	2.31 (1.25)	2.19 (0.76)	2.25 (1.0)
High-density lipoprotein cholesterol (HDL-c) (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	1.13 (0.18)	1.04 (0.23)	1.09 (0.21)
Low-density lipoprotein cholesterol (LDL-c) (mmol/L) [Median (Standard Deviation) ]
Median (Standard Deviation) [mmol/L]	2.69 (0.80)	2.35 (0.64)	2.52 (0.73)
Very low-density lipoprotein (VLDL) (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	8.26 (4.48)	7.86 (2.7)	8.07 (3.63)
Creatinine (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	70.72 (8.84)	61.88 (8.84)	70.36 (8.84)
Alanine aminotransferase (ALT) (U/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [U/L]	35.4 (24.4)	36.0 (19.7)	35.71 (21.70)
Aspartate aminotransferase (AST) (U/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [U/L]	29.0 (22.4)	23.1 (11.3)	26.08 (17.68)

Outcome Measures

1. Primary Outcome

Title	Total and First Phase of Insulin Secretion (Insulinogenic Index and Stumvoll Index) After 90 Days
Description	Total insulin secretion and first phase of insulin secretion were estimated at baseline and after 90 days using the insulinogenic index (ΔABC insulin / ΔABC glucose) and the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), respectively
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Momordica Charantia	Placebo
Arm/Group Description	Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months	Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months
Measure Participants	10	10
Total insulin secretion (Insulinogenic index)	0.41 (0.29)	0.23 (0.12)
First Phase of Insulin Secretion (Stumvoll index)	1135.7 (725.0)	309.0 (776.5)

2. Primary Outcome

Title	Insulin Sensitivity (Matsuda Index) After 90 Days
Description	Insulin sensitivity was calculated at baseline and after 90 days with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Momordica Charantia	Placebo
Arm/Group Description	Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months	Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months
Measure Participants	10	10
Mean (Standard Deviation) [index]	2.1 (1.6)	2.3 (1.0)

3. Secondary Outcome

Title	Fasting Serum Glucose (FSG) After 90 Days
Description	The glucose oxidase technique (Beckman Instruments, Inc., Brea, CA, USA) was used to determine fasting serum glucose at baseline and after 90 days with an intra- and interassay coefficient of variation of<1
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Momordica Charantia	Placebo
Arm/Group Description	Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months	Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months
Measure Participants	10	10
Mean (Standard Deviation) [mmol/L]	7.4 (2.9)	7.2 (2.3)

4. Secondary Outcome

Title	A1C After 90 Days
Description	A liquid chromatography method was used to evaluate A1C at baseline and after 90 days (Bio-Rad Laboratories, Hercules, CA, USA) with an intra and inter assay coefficient of variation of 0.4% and 1.6%, respectively
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Momordica Charantia	Placebo
Arm/Group Description	Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months	Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months
Measure Participants	10	10
Mean (Standard Deviation) [percentage]	7.1 (1.3)	7.1 (1.1)

5. Secondary Outcome

Title	Total Cholesterol After 90 Days
Description	The blood sample for the determination of total cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Momordica Charantia	Placebo
Arm/Group Description	Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months	Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months
Measure Participants	10	10
Mean (Standard Deviation) [mmol/L]	4.68 (1.02)	4.39 (0.52)

6. Secondary Outcome

Title	Triglycerides After 90 Days
Description	The blood sample for the determination of triglycerides was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Momordica Charantia	Placebo
Arm/Group Description	Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months	Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months
Measure Participants	10	10
Mean (Standard Deviation) [mmol/L]	1.93 (0.92)	2.02 (0.56)

7. Secondary Outcome

Title	High Density Lipoprotein Cholesterol (HDL-c) After 90 Days
Description	The blood sample for the determination of high density lipoprotein cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Momordica Charantia	Placebo
Arm/Group Description	Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months	Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months
Measure Participants	10	10
Mean (Standard Deviation) [mmol/L]	1.05 (0.31)	1.09 (0.27)

8. Secondary Outcome

Title	Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days
Description	The blood sample for the determination of low density lipoprotein cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Momordica Charantia	Placebo
Arm/Group Description	Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months	Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months
Measure Participants	10	10
Mean (Standard Deviation) [mmol/L]	2.75 (0.96)	2.41 (0.48)

9. Secondary Outcome

Title	Very Low Density Lipoprotein After 90 Days
Description	The blood sample for the determination of VLDL was taken after an overnight fast and was calculated at baseline and after 90 days as triglycerides/5
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Momordica Charantia	Placebo
Arm/Group Description	Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months	Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months
Measure Participants	10	10
Mean (Standard Deviation) [mmol/L]	6.92 (3.32)	7.22 (1.98)

10. Secondary Outcome

Title	Alanine Aminotransferase (ALT) After 90 Days
Description	The blood sample for the determination of ALT was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Momordica Charantia	Placebo
Arm/Group Description	Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months	Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months
Measure Participants	10	10
Mean (Standard Deviation) [U/L]	28.1 (19.4)	38.2 (18.9)

11. Secondary Outcome

Title	Aspartate Aminotransferase (AST) After 90 Days
Description	The blood sample for the determination of AST was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Momordica Charantia	Placebo
Arm/Group Description	Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months	Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months
Measure Participants	10	10
Mean (Standard Deviation) [U/L]	23.9 (16.5)	24.4 (6.7)

12. Secondary Outcome

Title	Creatinine After 90 Days
Description	The blood sample for the determination of creatinine was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Momordica Charantia	Placebo
Arm/Group Description	Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months	Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months
Measure Participants	10	10
Mean (Standard Deviation) [mmol/L]	70.72 (35.36)	79.56 (0.00)

13. Secondary Outcome

Title	Systolic Blood Pressure After 90 Days
Description	The systolic blood pressure was evaluated at baseline and after 90 days with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of SBP. The value was expressed on mmHg
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Momordica Charantia	Placebo
Arm/Group Description	Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months	Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months
Measure Participants	10	10
Mean (Standard Deviation) [mmHg]	119.6 (9.5)	115.4 (9.8)

14. Secondary Outcome

Title	Diastolic Blood Pressure After 90 Days
Description	The diastolic blood pressure was evaluated at baseline and after 90 days with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of DBP. The value was expressed on mmHg
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Momordica Charantia	Placebo
Arm/Group Description	Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months	Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months
Measure Participants	10	10
Mean (Standard Deviation) [mmHg]	75.1 (6.5)	72.6 (4.7)

15. Secondary Outcome

Title	Body Weight (BW) After 90 Days
Description	The body weight was evaluated at baseline and after 90 days after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Momordica Charantia	Placebo
Arm/Group Description	Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months	Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months
Measure Participants	10	10
Mean (Standard Deviation) [kg]	78.0 (9.2)	73.4 (10.8)

16. Secondary Outcome

Title	Body Mass Index (BMI) After 90 Days
Description	The BMI was calculated at baseline and after 90 days by the square of the body height, and is universally expressed in units of kg/m^2, resulting from mass in kilograms and height in metres
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Momordica Charantia	Placebo
Arm/Group Description	Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months	Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months
Measure Participants	10	10
Mean (Standard Deviation) [kg/m^2]	28.3 (1.9)	28.9 (3.6)

17. Secondary Outcome

Title	Fat Mass After 90 Days
Description	Fat mass was measured at baseline and after 90 days with an electric bioimpedance scale (Model TBF-300 A; Tanita Corporation of America Inc., Arlington Heights, IL)
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Momordica Charantia	Placebo
Arm/Group Description	Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months	Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months
Measure Participants	10	10
Mean (Standard Deviation) [percentage]	36.3 (7.6)	35.8 (6.9)

18. Secondary Outcome

Title	Waist Circumference (WC) After 90 Days
Description	The waist circumference was evaluated at baseline and after 90 days after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Momordica Charantia	Placebo
Arm/Group Description	Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months	Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months
Measure Participants	10	10
Mean (Standard Deviation) [cm]	104 (11)	98 (10)

19. Secondary Outcome

Title	2-h Serum Glucose After 90 Days
Description	The glucose oxidase technique (Beckman Instruments, Inc., Brea, CA, USA) was used to determine serum glucose at baseline and after 90 days with an intra- and interassay coefficient of variation of<1%
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Momordica Charantia	Placebo
Arm/Group Description	Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months	Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months
Measure Participants	10	10
Mean (Standard Deviation) [mmol/L]	13.2 (4.3)	14.3 (4.3)

20. Secondary Outcome

Title	AUC-glucose After 90 Days
Description	The polygonal formula was used to calculate area under the curve (AUC) of glucose at baseline and after 90 days
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Momordica Charantia	Placebo
Arm/Group Description	Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months	Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months
Measure Participants	10	10
Mean (Standard Deviation) [mmol/L/min]	1576 (391)	1663 (363)

21. Secondary Outcome

Title	AUC-insulin After 90 Days
Description	The polygonal formula was used to calculate area under the curve (AUC) of insulin at baseline and after 90 days
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Momordica Charantia	Placebo
Arm/Group Description	Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months	Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months
Measure Participants	10	10
Mean (Standard Deviation) [pmol/L/min]	65256 (42720)	41310 (20292)

Adverse Events

Time Frame	Adverse events were collected throughout the 90 days of the study
Arm/Group Title	Momordica Charantia		Placebo
Arm/Group Description	Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months		Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months
All Cause Mortality
	Momordica Charantia		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Momordica Charantia		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Momordica Charantia		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/12 (33.3%)		3/12 (25%)
Gastrointestinal disorders
Constipation	1/12 (8.3%)		2/12 (16.7%)
Abdominal distension	0/12 (0%)		2/12 (16.7%)
Nausea	2/12 (16.7%)		1/12 (8.3%)
Vomiting	1/12 (8.3%)		0/12 (0%)
Nervous system disorders
Headache	4/12 (33.3%)		3/12 (25%)
Dizziness	4/12 (33.3%)		1/12 (8.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.