Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin

NCT02370121 | Completed Phase 2 Results DMC

• 1 other identifier: CT-271281-YZ
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Metabolic Syndrome

Keywords

Gymnema Sylvestre; Insulin Secretion; Insulin Sensitivity; Central Obesity

Outcome Measures

Primary Outcomes (9)

• 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.

  Week 12

• 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.

  week 12

• 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.

  Week 12

• 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.

  week 12

• 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.

  week 12

• 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.

  week 12

• Total Insulin Secretion

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

  Week 12

• 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').

  week 12

• Insulin Sensitivity

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

  week 12

Secondary Outcomes (8)

• Body Weight (BW)

  week 12

• Body Mass Index (BMI)

  week 12

• Total Cholesterol (TC)

  week 12

• Low-density Lipoprotein Cholesterol (LDL-C)

  Week 12

• Very-low Density Lipoprotein (VLDL)

  week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Gymnema Sylvestre

EXPERIMENTAL

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

Placebo DRUG

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

Placebo

Gymnema Sylvestre DRUG

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

Gymnema Sylvestre

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guadalajara: lead

Related Publications (21)

• 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.

  PMID: 17964909 BACKGROUND

• 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.

  PMID: 17192339 BACKGROUND

• 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.

  PMID: 20516533 BACKGROUND

• 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.

  PMID: 20812281 RESULT

• 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.

  PMID: 11411567 RESULT

• 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.

  PMID: 2259217 RESULT

• Porchezhian E, Dobriyal RM. An overview on the advances of Gymnema sylvestre: chemistry, pharmacology and patents. Pharmazie. 2003 Jan;58(1):5-12.

  PMID: 12622244 RESULT

• 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.

  PMID: 2451154 RESULT

• 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.

  PMID: 23852298 RESULT

• 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.

  PMID: 24511547 RESULT

• 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.

  PMID: 25284929 RESULT

• 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.

  PMID: 23876572 RESULT

• 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.

  PMID: 22911568 RESULT

• 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.

  PMID: 15168555 RESULT

• 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.

  PMID: 1695875 RESULT

• 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.

  PMID: 10480510 RESULT

• 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.

  PMID: 8137688 RESULT

• 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.

  PMID: 25668616 RESULT

• 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.

  PMID: 10868854 RESULT

• 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.

  PMID: 16054141 RESULT

• 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.

  PMID: 24856809 RESULT

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance; Obesity, Abdominal

Interventions

Gurmarin protein, Gymnema sylvestre

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dra. Esperanza Martínez Abundis
• Organization: Institute of Experimental and Clinical Therapeutics

esperanzamartnezabundi@yahoo.com

+52-33-10-58-52-00

Study Officials

• Esperanza Martínez, PhD

  Institute of Experimental and Clinical Therapeutics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher Professor

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: February 24, 2015
• Study Start: February 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: June 18, 2019
• Results First Posted: June 3, 2016

Record last verified: 2019-06