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CompletedNCT02370121Updated Jun 18, 2019Results posted

Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin

A Phase 2 interventional study of Placebo and Gymnema Sylvestre in Metabolic Syndrome, sponsored by University of Guadalajara. Completed. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-06-18.

Sponsored by University of Guadalajara · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
All
01

Study summary

Gymnema sylvestre has demonstrated promising effects in the treatment of obesity, dyslipidemia, hypertension, insulin secretion, among others. The above mentioned findings show that Gymnema sylvestre has an excellent potential for the prevention and treatment of metabolic syndrome.

Read the detailed description

A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the modify International Diabetes Federation criteria. The patients received 300 mg capsules of Gymnema sylvestre or placebo, two times daily before breakfast and dinner for 90 days. Before and after intervention the investigators evaluated: The components of metabolic syndrome (waist circumference, triglycerides, high-density lipoprotein, fasting glucose and blood pressure), body weight, body mass index, total cholesterol, low-density lipoprotein, very-low-density lipoprotein, creatinine, aspartate transaminase and alanine transaminase.

Were calculated: Areas under the curve of glucose and insulin were calculated with de Trapezoidal formula. Total insulin secretion was evaluated with the Insulinogenic index and the insulin sensitivity was estimated using the Matsuda index.

02

Conditions studied

  • Metabolic Syndrome

Keywords

  • Gymnema Sylvestre
  • Insulin Secretion
  • Insulin Sensitivity
  • Central Obesity
03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's enrollment of 24 is below the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

University of Guadalajara is the lead sponsor of 94 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Letter of consent and release signed by each patient
  • Body mass index: 25-34.99 kg/m2
  • Body weight without variations above or under 5% during the three months prior to the study
  • Diagnostic of metabolic syndrome according to the modified International Diabetes Federation definition: Central obesity (defined as waist circumference ≥ 80 cm in women and ≥ 90 cm in men)

Plus any two of the following four factors:

  • Triglycerides: 150-499 mg/dL.
  • High density lipoprotein: Woman \< 50 mg/dL, man \< 40 mg/dL.
  • Blood pressure systolic:130-139 mmHg and/or Blood pressure diastolic: 85-89 mmHg
  • Fasting glucose: 100-125 mg/dL

Exclusion criteria

Exclusion Criteria:

  • Type 1 or 2 diabetes mellitus
  • Previous pharmacological treatment for components of metabolic syndrome
  • Mental or physical illness interfering with the study
  • Thyroid or cardiovascular disease
  • Pregnant or suspected pregnant women
  • Woman breastfeeding
  • Index of body mass: ≥ 35 kg/m2
  • Treatments known to affect metabolism of glucose, fats and affecting arterial tension
  • Patients with hepatic or renal diseases background
  • Patients diagnosed with kidneys disease
  • Calcined magnesium intolerance
  • Gymnema Sylvestre intolerance
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
24 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.

    Drug: Placebo

  • Experimental
    Gymnema Sylvestre

    600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.

    Drug: Gymnema Sylvestre

Interventions

  • DrugPlacebo

    Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.

    Also known as: Calcined Magnesia

  • DrugGymnema Sylvestre

    Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.

    Also known as: Gurmar

06

What researchers measure

Primary outcomes

  1. Waist Circumference (WC)

    The WC was evaluated 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: Week 12

  2. Triglycerides (TGs)

    The blood sample for determining of TGs, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.

    Time frame: week 12

  3. High-density Lipoprotein Cholesterol (HDL-C)

    The blood sample for determining of HDL-C, was taken after an overnight fast and was evaluated by colorimetric method. The value was expressed on mmol/L.

    Time frame: Week 12

  4. Fasting Plasma Glucose (FPG)

    The blood sample for determining of FPG, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.

    Time frame: week 12

  5. Systolic Blood Pressure (SBP)

    The SBP was evaluated 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: week 12

  6. Diastolic Blood Pressure (DBP)

    The DBP was evaluated 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: week 12

  7. Total Insulin Secretion

    The total insulin secretion was calculated by the insulinogenic index (ΔABC insulin / ΔABC glucose).

    Time frame: Week 12

  8. First Phase of Insulin Secretion

    The 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').

    Time frame: week 12

  9. Insulin Sensitivity

    The insulin sensitivity was calculated with Matsuda index \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\].

    Time frame: week 12

Secondary outcomes

  1. Body Weight (BW)

    The BW was evaluated after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal.

    Time frame: week 12

  2. Body Mass Index (BMI)

    The BMI was calculated by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.

    Time frame: week 12

  3. Total Cholesterol (TC)

    The blood sample for determining of TC, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.

    Time frame: week 12

  4. Low-density Lipoprotein Cholesterol (LDL-C)

    The blood sample for determining of LDL-C, was taken after an overnight fast and was calculated by Friedewald formula. The value was expressed on mmol/L.

    Time frame: Week 12

  5. Very-low Density Lipoprotein (VLDL)

    The blood sample for determining the VLDL, was taken after an overnight fast and was calculated as triglycerides/5. The value was expressed on mmol/L.

    Time frame: week 12

  6. 2-hour Postload Plasma Glucose (2-h PG)

    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: week 12

  7. Area Under the Curve of Glucose (AUCG)

    The estimation for AUCG was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed mmol/L/min.

    Time frame: week 12

  8. Area Under the Curve of Insulin (AUCI)

    The estimation for AUCI was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed on pmol/L/min.

    Time frame: week 12

07

Results

Posted Jun 3, 2016

Participant flow

Participant flow — Overall Study
MilestonePlaceboGymnema Sylvestre
Started1212
Completed1111
Not completed11
Withdrew: Lost to follow-up11

Outcome measures

PrimaryWaist Circumference (WC)

The WC was evaluated 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:
Week 12
Reported as:
Mean · cm
Waist Circumference (WC)
cmPlaceboGymnema Sylvestre
Waist Circumference (WC)101 ± 1596 ± 7
Statistical analysis
  • Placebo vs Gymnema Sylvestre · Wilcoxon (Mann-Whitney) · p = 0.57
PrimaryTriglycerides (TGs)

The blood sample for determining of TGs, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.

Time frame:
week 12
Reported as:
Mean · mmol/L
Triglycerides (TGs)
mmol/LPlaceboGymnema Sylvestre
Triglycerides (TGs)2.79 ± 0.591.70 ± 0.75
Statistical analysis
  • Placebo vs Gymnema Sylvestre · Wilcoxon (Mann-Whitney) · p = 0.07
PrimaryHigh-density Lipoprotein Cholesterol (HDL-C)

The blood sample for determining of HDL-C, was taken after an overnight fast and was evaluated by colorimetric method. The value was expressed on mmol/L.

Time frame:
Week 12
Reported as:
Mean · mmol/L
High-density Lipoprotein Cholesterol (HDL-C)
mmol/LPlaceboGymnema Sylvestre
High-density Lipoprotein Cholesterol (HDL-C)1.03 ± 0.251.08 ± 0.31
Statistical analysis
  • Placebo vs Gymnema Sylvestre · Wilcoxon (Mann-Whitney) · p = 0.79
PrimaryFasting Plasma Glucose (FPG)

The blood sample for determining of FPG, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.

Time frame:
week 12
Reported as:
Mean · mmol/L
Fasting Plasma Glucose (FPG)
mmol/LPlaceboGymnema Sylvestre
Fasting Plasma Glucose (FPG)5.00 ± 0.614.83 ± 0.72
Statistical analysis
  • Placebo vs Gymnema Sylvestre · Wilcoxon (Mann-Whitney) · p = 0.08
PrimarySystolic Blood Pressure (SBP)

The SBP was evaluated 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:
week 12
Reported as:
Mean · mmHg
Systolic Blood Pressure (SBP)
mmHgPlaceboGymnema Sylvestre
Systolic Blood Pressure (SBP)122 ± 13121 ± 11
Statistical analysis
  • Placebo vs Gymnema Sylvestre · Wilcoxon (Mann-Whitney) · p = 0.95
PrimaryDiastolic Blood Pressure (DBP)

The DBP was evaluated 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:
week 12
Reported as:
Mean · mmHg
Diastolic Blood Pressure (DBP)
mmHgPlaceboGymnema Sylvestre
Diastolic Blood Pressure (DBP)83 ± 778 ± 8
Statistical analysis
  • Placebo vs Gymnema Sylvestre · Wilcoxon (Mann-Whitney) · p = 0.92
PrimaryTotal Insulin Secretion

The total insulin secretion was calculated by the insulinogenic index (ΔABC insulin / ΔABC glucose).

Time frame:
Week 12
Reported as:
Mean · unitless
Total Insulin Secretion
unitlessPlaceboGymnema Sylvestre
Total Insulin Secretion0.95 ± 0.660.59 ± 0.25
Statistical analysis
  • Placebo vs Gymnema Sylvestre · Wilcoxon (Mann-Whitney) · p = 0.42
PrimaryFirst Phase of Insulin Secretion

The 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').

Time frame:
week 12
Reported as:
Mean · unitless
First Phase of Insulin Secretion
unitlessPlaceboGymnema Sylvestre
First Phase of Insulin Secretion1805 ± 7211366 ± 472
Statistical analysis
  • Placebo vs Gymnema Sylvestre · Wilcoxon (Mann-Whitney) · p = 0.77
PrimaryInsulin Sensitivity

The insulin sensitivity was calculated with Matsuda index \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\].

Time frame:
week 12
Reported as:
Mean · unitless
Insulin Sensitivity
unitlessPlaceboGymnema Sylvestre
Insulin Sensitivity2.5 ± 1.44.1 ± 2.1
Statistical analysis
  • Placebo vs Gymnema Sylvestre · Wilcoxon (Mann-Whitney) · p = 0.17
SecondaryBody Weight (BW)

The BW was evaluated after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal.

Time frame:
week 12
Reported as:
Mean · kg
Body Weight (BW)
kgPlaceboGymnema Sylvestre
Body Weight (BW)80.3 ± 18.277.9 ± 8.4
Statistical analysis
  • Placebo vs Gymnema Sylvestre · Wilcoxon (Mann-Whitney) · p = 0.02
SecondaryBody Mass Index (BMI)

The BMI was calculated by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.

Time frame:
week 12
Reported as:
Mean · kg/m^2
Body Mass Index (BMI)
kg/m^2PlaceboGymnema Sylvestre
Body Mass Index (BMI)30.70 ± 3.7530.43 ± 2.23
Statistical analysis
  • Placebo vs Gymnema Sylvestre · Wilcoxon (Mann-Whitney) · p = 0.02
SecondaryTotal Cholesterol (TC)

The blood sample for determining of TC, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.

Time frame:
week 12
Reported as:
Mean · mmol/L
Total Cholesterol (TC)
mmol/LPlaceboGymnema Sylvestre
Total Cholesterol (TC)5.04 ± 0.624.55 ± 0.98
Statistical analysis
  • Placebo vs Gymnema Sylvestre · Wilcoxon (Mann-Whitney) · p = 0.83
SecondaryLow-density Lipoprotein Cholesterol (LDL-C)

The blood sample for determining of LDL-C, was taken after an overnight fast and was calculated by Friedewald formula. The value was expressed on mmol/L.

Time frame:
Week 12
Reported as:
Mean · mmol/L
Low-density Lipoprotein Cholesterol (LDL-C)
mmol/LPlaceboGymnema Sylvestre
Low-density Lipoprotein Cholesterol (LDL-C)2.77 ± 0.542.69 ± 0.59
Statistical analysis
  • Placebo vs Gymnema Sylvestre · Wilcoxon (Mann-Whitney) · p = 0.24
SecondaryVery-low Density Lipoprotein (VLDL)

The blood sample for determining the VLDL, was taken after an overnight fast and was calculated as triglycerides/5. The value was expressed on mmol/L.

Time frame:
week 12
Reported as:
Mean · mmol/L
Very-low Density Lipoprotein (VLDL)
mmol/LPlaceboGymnema Sylvestre
Very-low Density Lipoprotein (VLDL)0.56 ± 0.120.35 ± 0.15
Statistical analysis
  • Placebo vs Gymnema Sylvestre · Wilcoxon (Mann-Whitney) · p = 0.05
Secondary2-hour Postload Plasma Glucose (2-h PG)

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:
week 12
Reported as:
Mean · mmol/L
2-hour Postload Plasma Glucose (2-h PG)
mmol/LPlaceboGymnema Sylvestre
2-hour Postload Plasma Glucose (2-h PG)6.83 ± 2.007.22 ± 3.05
Statistical analysis
  • Placebo vs Gymnema Sylvestre · Wilcoxon (Mann-Whitney) · p = 0.32
SecondaryArea Under the Curve of Glucose (AUCG)

The estimation for AUCG was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed mmol/L/min.

Time frame:
week 12
Reported as:
Mean · mmol/L/min
Area Under the Curve of Glucose (AUCG)
mmol/L/minPlaceboGymnema Sylvestre
Area Under the Curve of Glucose (AUCG)965 ± 235914 ± 267
Statistical analysis
  • Placebo vs Gymnema Sylvestre · Wilcoxon (Mann-Whitney) · p = 0.17
SecondaryArea Under the Curve of Insulin (AUCI)

The estimation for AUCI was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed on pmol/L/min.

Time frame:
week 12
Reported as:
Mean · pmol/L/min
Area Under the Curve of Insulin (AUCI)
pmol/L/minPlaceboGymnema Sylvestre
Area Under the Curve of Insulin (AUCI)90816 ± 4533660468 ± 37290
Statistical analysis
  • Placebo vs Gymnema Sylvestre · Wilcoxon (Mann-Whitney) · p = 0.89

Adverse events

Collected over Adverse events were collected throughout the 90 days of the study.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—0/12 (0%)4/12 (33.3%)
Gymnema Sylvestre—0/12 (0%)8/12 (66.7%)
Most frequent other events
Most frequent other events
EventPlaceboGymnema Sylvestre
headacheNervous system disorders2/121/12
DiarrheaGastrointestinal disorders1/122/12
PyrosisGastrointestinal disorders0/122/12
PolydipsiaMetabolism and nutrition disorders0/122/12
Abdominal distensionGastrointestinal disorders1/121/12

Baseline characteristics

Age, Continuous
Age, Continuous(years)PlaceboGymnema SylvestreTotal
Mean41 ± 443 ± 142 ± 4
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboGymnema SylvestreTotal
Female101020
Male224
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboGymnema SylvestreTotal
Hispanic or Latino121224
Not Hispanic or Latino000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)PlaceboGymnema SylvestreTotal
Mexico121224
Body weight (BW)
Body weight (BW)(kg)PlaceboGymnema SylvestreTotal
Mean78.8 ± 16.181.3 ± 10.680.2 ± 15.4
Body mass index (BMI)
Body mass index (BMI)(kg/m^2)PlaceboGymnema SylvestreTotal
Mean30.29 ± 3.2131.24 ± 2.5530.56 ± 2.98
Waist circumference (WC)
Waist circumference (WC)(cm)PlaceboGymnema SylvestreTotal
Mean98 ± 1499 ± 1098 ± 14
Systolic blood pressure (SBP)
Systolic blood pressure (SBP)(mmHg)PlaceboGymnema SylvestreTotal
Mean123 ± 11121 ± 10122 ± 15

13 further baseline measures are reported on the registry.

08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Lann D, LeRoith D. Insulin resistance as the underlying cause for the metabolic syndrome. Med Clin North Am. 2007 Nov;91(6):1063-77, viii. doi: 10.1016/j.mcna.2007.06.012. PubMed 17964909 ↗
  • Abdul-Ghani MA, Matsuda M, Balas B, DeFronzo RA. Muscle and liver insulin resistance indexes derived from the oral glucose tolerance test. Diabetes Care. 2007 Jan;30(1):89-94. doi: 10.2337/dc06-1519. PubMed 17192339 ↗
  • Sandeep S, Gokulakrishnan K, Velmurugan K, Deepa M, Mohan V. Visceral & subcutaneous abdominal fat in relation to insulin resistance & metabolic syndrome in non-diabetic south Indians. Indian J Med Res. 2010 May;131:629-35. PubMed 20516533 ↗
  • Al-Romaiyan A, Liu B, Asare-Anane H, Maity CR, Chatterjee SK, Koley N, Biswas T, Chatterji AK, Huang GC, Amiel SA, Persaud SJ, Jones PM. A novel Gymnema sylvestre extract stimulates insulin secretion from human islets in vivo and in vitro. Phytother Res. 2010 Sep;24(9):1370-6. doi: 10.1002/ptr.3125. PubMed 20812281 ↗
  • Shigematsu N, Asano R, Shimosaka M, Okazaki M. Effect of administration with the extract of Gymnema sylvestre R. Br leaves on lipid metabolism in rats. Biol Pharm Bull. 2001 Jun;24(6):713-7. doi: 10.1248/bpb.24.713. PubMed 11411567 ↗
  • Baskaran K, Kizar Ahamath B, Radha Shanmugasundaram K, Shanmugasundaram ER. Antidiabetic effect of a leaf extract from Gymnema sylvestre in non-insulin-dependent diabetes mellitus patients. J Ethnopharmacol. 1990 Oct;30(3):295-300. doi: 10.1016/0378-8741(90)90108-6. PubMed 2259217 ↗
  • Porchezhian E, Dobriyal RM. An overview on the advances of Gymnema sylvestre: chemistry, pharmacology and patents. Pharmazie. 2003 Jan;58(1):5-12. PubMed 12622244 ↗
  • Koshu K, Hirota S, Sonobe M, Takahashi S, Takaku A, Saito T, Ushijima T. [Continuous recording of cerebral blood flow by means of thermal diffusion method using Peltier stack]. Neurol Med Chir (Tokyo). 1987 Aug;27(8):724-8. doi: 10.2176/nmc.27.724. No abstract available. Japanese. PubMed 2451154 ↗
  • Bhansali S, Shafiq N, Pandhi P, Singh AP, Singh I, Singh PK, Sharma S, Malhotra S. Effect of a deacyl gymnemic acid on glucose homeostasis & metabolic parameters in a rat model of metabolic syndrome. Indian J Med Res. 2013 Jun;137(6):1174-9. PubMed 23852298 ↗
  • Tiwari P, Mishra BN, Sangwan NS. Phytochemical and pharmacological properties of Gymnema sylvestre: an important medicinal plant. Biomed Res Int. 2014;2014:830285. doi: 10.1155/2014/830285. Epub 2014 Jan 6. PubMed 24511547 ↗
  • Kumar V, Bhandari U, Tripathi CD, Khanna G. Protective Effect of Gymnema sylvestre Ethanol Extract on High Fat Diet-induced Obese Diabetic Wistar Rats. Indian J Pharm Sci. 2014 Jul;76(4):315-22. PubMed 25284929 ↗
  • Astell KJ, Mathai ML, Su XQ. Plant extracts with appetite suppressing properties for body weight control: a systematic review of double blind randomized controlled clinical trials. Complement Ther Med. 2013 Aug;21(4):407-16. doi: 10.1016/j.ctim.2013.05.007. Epub 2013 Jun 24. PubMed 23876572 ↗
  • Al-Romaiyan A, King AJ, Persaud SJ, Jones PM. A novel extract of Gymnema sylvestre improves glucose tolerance in vivo and stimulates insulin secretion and synthesis in vitro. Phytother Res. 2013 Jul;27(7):1006-11. doi: 10.1002/ptr.4815. Epub 2012 Aug 21. PubMed 22911568 ↗
  • Ogawa Y, Sekita K, Umemura T, Saito M, Ono A, Kawasaki Y, Uchida O, Matsushima Y, Inoue T, Kanno J. [Gymnema sylvestre leaf extract: a 52-week dietary toxicity study in Wistar rats]. Shokuhin Eiseigaku Zasshi. 2004 Feb;45(1):8-18. doi: 10.3358/shokueishi.45.8. Japanese. PubMed 15168555 ↗
  • Okabayashi Y, Tani S, Fujisawa T, Koide M, Hasegawa H, Nakamura T, Fujii M, Otsuki M. Effect of Gymnema sylvestre, R.Br. on glucose homeostasis in rats. Diabetes Res Clin Pract. 1990 May-Jun;9(2):143-8. doi: 10.1016/0168-8227(90)90106-4. PubMed 1695875 ↗
  • Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic insulin clamp. Diabetes Care. 1999 Sep;22(9):1462-70. doi: 10.2337/diacare.22.9.1462. PubMed 10480510 ↗
  • Tai MM. A mathematical model for the determination of total area under glucose tolerance and other metabolic curves. Diabetes Care. 1994 Feb;17(2):152-4. doi: 10.2337/diacare.17.2.152. PubMed 8137688 ↗
  • Renga B, Festa C, De Marino S, Di Micco S, D'Auria MV, Bifulco G, Fiorucci S, Zampella A. Molecular decodification of gymnemic acids from Gymnema sylvestre. Discovery of a new class of liver X receptor antagonists. Steroids. 2015 Apr;96:121-31. doi: 10.1016/j.steroids.2015.01.024. Epub 2015 Feb 7. PubMed 25668616 ↗
  • Stumvoll M, Mitrakou A, Pimenta W, Jenssen T, Yki-Jarvinen H, Van Haeften T, Renn W, Gerich J. Use of the oral glucose tolerance test to assess insulin release and insulin sensitivity. Diabetes Care. 2000 Mar;23(3):295-301. doi: 10.2337/diacare.23.3.295. PubMed 10868854 ↗
  • Izutani Y, Murai T, Imoto T, Ohnishi M, Oda M, Ishijima S. Gymnemic acids inhibit rabbit glyceraldehyde-3-phosphate dehydrogenase and induce a smearing of its electrophoretic band and dephosphorylation. FEBS Lett. 2005 Aug 15;579(20):4333-6. doi: 10.1016/j.febslet.2005.06.070. PubMed 16054141 ↗
  • Wang Y, Dawid C, Kottra G, Daniel H, Hofmann T. Gymnemic acids inhibit sodium-dependent glucose transporter 1. J Agric Food Chem. 2014 Jun 25;62(25):5925-31. doi: 10.1021/jf501766u. Epub 2014 Jun 10. PubMed 24856809 ↗

Individual participant data

Plan to share: Undecided

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02370121
Lead sponsor
University of Guadalajara
Responsible party
Esperanza Martínez-Abundis (Researcher Professor, University of Guadalajara) — Principal investigator
First posted
Feb 24, 2015
Start date
Feb 2013
Primary completion
Dec 2014
Completion
Jan 2015
Results posted
Jun 3, 2016
Last update
Jun 18, 2019

Study contacts

Esperanza Martínez, PhD
principal investigator · Institute of Experimental and Clinical Therapeutics

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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