Effect of Gymnema Sylvestre on Patients With Impaired Glucose Tolerance.

• Sponsor: University of Guadalajara (Other)
• Overall Status: Completed
• CT.gov ID: NCT02708966
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 31
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

Prediabetes (PD) was defined as an state in which glucose levels are above normal but not enough to meet criteria for the diagnosis of type 2 diabetes (T2D). PD can be presented as impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and glycated hemoglobin A1c (A1C) altered. The International Diabetes Federation (IDF) reported that in 2013 the prevalence of IGT was 6.9% which is equivalent to approximately 316 million individuals with IGT, it is expected that by 2035 this number will increase to 417 million people affected.

Many hypoglycemic effects attributed to Gymnema sylvestre have been reported, including:

increase of insulin secretion, regeneration of pancreatic islet cells, increased glucose utilization in various ways and inhibition of glucose uptake in the intestine.

Condition or Disease	Intervention/Treatment	Phase
Impaired Glucose Tolerance	Drug: Gymnema Sylvestre; Drug: Placebo	Phase 2

Detailed Description

The target is to evaluate the effect of the administration of Gymnema Sylvestre on glycemic control, insulin secretion and insulin sensibility on patients with IGT. The investigators will conduct a double-blind trial, randomized, placebo control group, each group 12 female and male patients, between 30 and 59 years old with IGT (2-h values in the oral glucose tolerance test, OGTT) from 140 mg / dL to 199 mg / dL), Body Mass Index (BMI) from 25 to 34.9 kg / m2. Randomization will determine who will receive the intervention during the 9-week trial (Gymnema Sylvestre capsules, 300 mg 2 times daily with the first bite of breakfast and dinner or homologated placebo capsules). The clinical findings and laboratory tests include a metabolic profile and biosafety, which will be made at baseline and at week 9. Body weight, body fat, BMI and blood pressure will be determined during the initial and final visit.

Adverse events and adherence to treatment will be documented. Statistical analysis:

Mann-Whitney U test, Wilcoxon and Fisher exact test. It is considered with significance at p <0.05.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effect of the Administration of Gymnema Sylvestre on Glycemic Control, Insulin Secretion and Insulin Sensitivity in Patients With Impaired Glucose Tolerance.
• Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Sep 1, 2018
• Actual Study Completion Date: Oct 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gymnema Sylvestre Patients with IGT	Drug: Gymnema Sylvestre; Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner; Other Names: Gurmar
Placebo Comparator: Placebo Patients with IGT	Drug: Placebo; Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner; Other Names: Calcined Magnesia

Outcome Measures

Primary Outcome Measures

1. Fasting Plasma Glucose [90 days]

   After intervention by spectrophotometry

2. 2-hour Post Load Plasma Glucose (2-h PG) [90 days]

   The blood sample for determining of 2-h PG, was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L.

3. Glycated Hemoglobin A1c (A1C) [90 days]

   After intervention by high-performance liquid chromatography

4. Total Insulin Secretion (Insulinogenic Index) [90 days]

   Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose) after intervention.

5. First Phase of Insulin Secretion [90 days]

   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') after intervention.

6. Insulin Sensitivity (Matsuda Index) [90 days]

   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)] after intervention.

Secondary Outcome Measures

1. Area Under the Curve of Glucose [90 days]

   Area under the curve of glucose was obtained using the trapezoidal integration.

2. Area Under the Curve of Insulin [90 days]

   After intervention area under the curve of insulin

3. Body Weight (BW) [12 weeks]

   The weight was measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12

4. Body Mass Index (BMI) [12 weeks]

   The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12

5. Waist Circumference (WC) [12 weeks]

   Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflects the waist circumference measure at week 12

6. Systolic Blood Pressure (SBP) [12 weeks]

   The Systolic Blood Pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12

7. Diastolic Blood Pressure (DBP) [12 weeks]

   The Diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12

8. Total Cholesterol [90 days]

   After intervention by spectrophotometry

9. Triglycerides [90 days]

   After intervention by spectrophotometry

10. High Density Lipoprotein Cholesterol [90 days]

    After intervention by spectrophotometry

11. Low Density Lipoprotein [90 days]

    After intervention by spectrophotometry

12. Very Low Density Lipoprotein [90 days]

    After intervention by spectrophotometry

13. Creatinine [90 days]

    After intervention by spectrophotometry

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 59 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• BMI: 25.0-34.99 kg / m2.

• Diagnosis of IGT (2h-OGTT Values between 140mg / dl and 199mg / dl.)

• Written informed consent.

• body weight stable over the last 3 months.

• Women in follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the time of laboratory tests.

• Women who are not contemplated get pregnant within the next 6 months.

Exclusion Criteria:

• Women pregnant or breastfeeding.

• Physical or mental disability that makes it impossible to perform the intervention.

• Diagnosis of hypertension or heart failure.

• Smokers.

• Untreated thyroid disease.

• Consumption of oral agents or other medications or supplements with proven properties that modify the behavior of glucose and lipids (oral hypoglycemic agents, insulin, lipid-lowering).

• Diagnosis of liver disease or elevation twice of the upper normal value of liver enzymes.

• Diagnosis of renal disease or creatinine > 1.5 mg / dl.

• Diagnosis of Type 2 Diabetes Mellitus (T2DM) Fasting glucose ≥ 126 mg / dL and/or 2h-OGTT ≥ 200 mg / dL and/or A1C ≥ 6.5%.

• Total Cholesterol ≥ 280 mg/dL.

• Triglycerides ≥ 300 mg/dL.

• Known allergy to calcined magnesia or Gymnema sylvestre.

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, Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Jan 18, 2016

More Information

Publications

None provided.

• Responsible Party: Esperanza Martínez-Abundis, PHD, University of Guadalajara
• ClinicalTrials.gov Identifier: NCT02708966
• Other Study ID Numbers: GSIG
• First Posted: Mar 15, 2016
• Last Update Posted: Feb 2, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Esperanza Martínez-Abundis, PHD, University of Guadalajara: Gymnema Sylvestre; Glycemic control
• Additional relevant MeSH terms: Glucose Intolerance

Study Results

Participant Flow

Arm/Group Title	Gymnema Sylvestre	Placebo
Arm/Group Description	Patients with impaired glucose tolerance (IGT) Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Period Title: Overall Study
STARTED	15	15
COMPLETED	13	13
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Gymnema Sylvestre	Placebo	Total
Arm/Group Description	Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Total of all reporting groups
Overall Participants	15	15	30
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	47 (10)	44 (7)	45 (9)
Sex: Female, Male (Count of Participants)
Female	11 73.3%	11 73.3%	22 73.3%
Male	4 26.7%	4 26.7%	8 26.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	15 100%	15 100%	30 100%
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	15 100%	15 100%	30 100%
Body Weight (BW) (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	79.6 (11.9)	79.1 (16.8)	79.3 (14.3)
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	31.1 (3.7)	29.8 (5.2)	30.4 (4.4)
Waist circumference (WC) (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	97.3 (6.9)	98.8 (9.8)	98 (8.3)
Systolic blood pressure (SBP) (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	117 (12)	119 (12)	118 (12)
Diastolic blood pressure (DBP) (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	77 (13)	77 (8)	77 (11)
Triglycerides (TGs) (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	1.8 (1.3)	1.5 (0.7)	1.7 (1.0)
Total cholesterol (TC) (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	5.1 (0.1)	5.2 (0.9)	5.1 (0.9)
high-density lipoprotein cholesterol (HDL-C) (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	1.0 (0.1)	0.9 (0.3)	0.9 (0.2)
Low-density lipoprotein cholesterol (LDL-C) (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	3.5 (0.8)	3.5 (0.5)	3.5 (0.7)
Very-low density lipoprotein (VLDL) (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	0.4 (0.3)	0.3 (0.1)	0.3 (0.2)
Fasting plasma glucose (FPG) (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	5.9 (0.4)	5.6 (0.4)	5.8 (0.4)
2-hour postload plasma glucose (2-h PG) (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	9.1 (1.2)	8.6 (0.8)	8.9 (1)
Glycated hemoglobin A1c (Percent of glycated hemoglobin) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percent of glycated hemoglobin]	5.8 (0.3)	5.6 (0.2)	5.7 (0.3)
Creatinine (µmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [µmol/L]	79.5 (17.7)	70.8 (26.5)	70.8 (17.7)
Area under the curve of glucose (AUCG) (mmol/L/min) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L/min]	1157 (147)	1078 (137)	1120 (146)
Area under the curve of insulin (AUCI) (pmol/L/min) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pmol/L/min]	68,348 (20,329)	63,544 (28,041)	65946 (24188)
Total insulin secretion (unitless) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [unitless]	0.56 (0.20)	0.54 (0.22)	0.54 (0.22)
First phase of insulin secretion (unitless) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [unitless]	1297 (550)	1391 (712)	1344 (627)
Insulin sensitivity (unitless) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [unitless]	1.8 (0.8)	2.5 (1.5)	2.1 (1.2)

Outcome Measures

1. Primary Outcome

Title	Fasting Plasma Glucose
Description	After intervention by spectrophotometry
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

All participants, including those who dropped out before the end were taken into account for statical analysis (intention to treat).

Arm/Group Title	Gymnema Sylvestre	Placebo
Arm/Group Description	Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Measure Participants	13	13
Mean (Standard Deviation) [mmol/L]	77.4 (11.6)	77.7 (13.2)

2. Primary Outcome

Title	2-hour Post Load Plasma Glucose (2-h PG)
Description	The blood sample for determining of 2-h PG, was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gymnema Sylvestre	Placebo
Arm/Group Description	Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Measure Participants	13	13
Mean (Standard Deviation) [mmol/L]	7.8 (1.7)	7.9 (1.1)

3. Primary Outcome

Title	Glycated Hemoglobin A1c (A1C)
Description	After intervention by high-performance liquid chromatography
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gymnema Sylvestre	Placebo
Arm/Group Description	Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Measure Participants	13	13
Mean (Standard Deviation) [Percent of glycated hemoglobin]	5.4 (0.4)	5.7 (0.5)

4. Primary Outcome

Title	Total Insulin Secretion (Insulinogenic Index)
Description	Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose) after intervention.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gymnema Sylvestre	Placebo
Arm/Group Description	Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Measure Participants	13	13
Mean (Standard Deviation) [Unitless]	0.51 (0.21)	0.49 (0.18)

5. Primary Outcome

Title	First Phase of Insulin Secretion
Description	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') after intervention.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gymnema Sylvestre	Placebo
Arm/Group Description	Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Measure Participants	13	13
Mean (Standard Deviation) [Unitless]	1399 (552)	1528 (677)

6. Primary Outcome

Title	Insulin Sensitivity (Matsuda Index)
Description	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)] after intervention.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gymnema Sylvestre	Placebo
Arm/Group Description	Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Measure Participants	13	13
Mean (Standard Deviation) [Unitless]	2.4 (1.2)	2.5 (1.2)

7. Secondary Outcome

Title	Area Under the Curve of Glucose
Description	Area under the curve of glucose was obtained using the trapezoidal integration.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gymnema Sylvestre	Placebo
Arm/Group Description	Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Measure Participants	13	13
Mean (Standard Deviation) [mmol/l/min]	1075 (253)	1018 (158)

8. Secondary Outcome

Title	Area Under the Curve of Insulin
Description	After intervention area under the curve of insulin
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gymnema Sylvestre	Placebo
Arm/Group Description	Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Measure Participants	13	13
Mean (Standard Deviation) [mmol/l/min]	56968 (20787)	53374 (20663)

9. Secondary Outcome

Title	Body Weight (BW)
Description	The weight was measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gymnema Sylvestre	Placebo
Arm/Group Description	Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Measure Participants	13	13
Mean (Standard Deviation) [kg]	77.4 (11.6)	77.7 (13.2)

10. Secondary Outcome

Title	Body Mass Index (BMI)
Description	The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gymnema Sylvestre	Placebo
Arm/Group Description	Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Measure Participants	13	13
Mean (Standard Deviation) [kg/m^2]	30.3 (3.6)	29.3 (4.4)

11. Secondary Outcome

Title	Waist Circumference (WC)
Description	Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflects the waist circumference measure at week 12
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gymnema Sylvestre	Placebo
Arm/Group Description	Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Measure Participants	13	13
Mean (Standard Deviation) [cm]	97.3 (7.7)	99 (7.6)

12. Secondary Outcome

Title	Systolic Blood Pressure (SBP)
Description	The Systolic Blood Pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gymnema Sylvestre	Placebo
Arm/Group Description	Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Measure Participants	13	13
Mean (Standard Deviation) [mmHg]	120 (15)	120 (14)

13. Secondary Outcome

Title	Diastolic Blood Pressure (DBP)
Description	The Diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gymnema Sylvestre	Placebo
Arm/Group Description	Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Measure Participants	13	13
Mean (Standard Deviation) [mmHg]	75 (10)	77 (8)

14. Secondary Outcome

Title	Total Cholesterol
Description	After intervention by spectrophotometry
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gymnema Sylvestre	Placebo
Arm/Group Description	Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Measure Participants	13	13
Mean (Standard Deviation) [mmol/L]	4.7 (1.2)	5.4 (1)

15. Secondary Outcome

Title	Triglycerides
Description	After intervention by spectrophotometry
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gymnema Sylvestre	Placebo
Arm/Group Description	Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Measure Participants	13	13
Mean (Standard Deviation) [mmol/L]	1.7 (0.9)	1.6 (0.7)

16. Secondary Outcome

Title	High Density Lipoprotein Cholesterol
Description	After intervention by spectrophotometry
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gymnema Sylvestre	Placebo
Arm/Group Description	Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Measure Participants	13	13
Mean (Standard Deviation) [mmol/L]	0.9 (0.2)	1.0 (0.3)

17. Secondary Outcome

Title	Low Density Lipoprotein
Description	After intervention by spectrophotometry
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gymnema Sylvestre	Placebo
Arm/Group Description	Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Measure Participants	13	13
Mean (Standard Deviation) [mmol/L]	2.5 (1.3)	3.2 (1.6)

18. Secondary Outcome

Title	Very Low Density Lipoprotein
Description	After intervention by spectrophotometry
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gymnema Sylvestre	Placebo
Arm/Group Description	Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Measure Participants	13	13
Mean (Standard Deviation) [mmol/L]	0.3 (0.2)	0.3 (0.1)

19. Secondary Outcome

Title	Creatinine
Description	After intervention by spectrophotometry
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gymnema Sylvestre	Placebo
Arm/Group Description	Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Measure Participants	13	13
Mean (Standard Deviation) [µmol/L]	70.8 (17.6)	70.8 (17.6)

Adverse Events

Time Frame	Adverse events were collected throughout the 90 days of the study
Arm/Group Title	Gymnema Sylvestre		Placebo
Arm/Group Description	Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner		Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
All Cause Mortality
	Gymnema Sylvestre		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Serious Adverse Events
	Gymnema Sylvestre		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Gymnema Sylvestre		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/15 (26.7%)		6/15 (40%)
Gastrointestinal disorders
Diarrea	4/15 (26.7%)		2/15 (13.3%)
Abdominal distention	4/15 (26.7%)		6/15 (40%)
Nausea	2/15 (13.3%)		2/15 (13.3%)
Anorexy	1/15 (6.7%)		0/15 (0%)
Sweet taste intolerance	2/15 (13.3%)		0/15 (0%)
Dry mouth	2/15 (13.3%)		1/15 (6.7%)
General disorders
Polydipsia	1/15 (6.7%)		0/15 (0%)
Nervous system disorders
Headache	2/15 (13.3%)		3/15 (20%)

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.