Effect of Gynostemma Pentaphyllum Tea in Insulin Sensitivity in Type 2 Diabetic Patients

Type 2 Diabetes Clinical Trial

Official title:

Gynostemma Pentaphyllum Tea Improves Insulin Sensitivity in Type 2 Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254084
• Other study ID #: Diabetes II-Study3
• Secondary ID: Study 3
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 3, 2010
• Last updated: December 3, 2010
• Start date: February 2010
• Est. completion date: November 2010

Study information

• Verified date: February 2010
• Source: Hanoi Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Hanoi Medical University review board (HMURB) in Bio-Medical research
• Study type: Interventional

Clinical Trial Summary

The aim of the present study was to investigate the effects of Gynostemma Pentaphyllum tea on insulin sensitivity in drug-naïve type 2 diabetic patients.

Description:

In Vietnam, traditional herbal medicines have played a major role in the management of diabetes for centuries. Gynostemma Pentaphyllum (GP) Makino (Family Cucurbitaceae) is a perennial creeping herb growing wild in the mountainous regions of Vietnam, China and some other Asian countries and was widely used in Southeast Asian countries as an herbal medicine and being beneficial for the prevention and treatment of diabetes. We have previously published the evidences that GP tea possessed anti-diabetic effect with good safety data in newly diagnosed T2D patients, and had effect on insulin sensitivity. In addition extract of GP had been shown to reduce both hyperglycemia and hyperlipidemia in diabetic Zucker Fatty rats. So the present study was to investigate the effects of Gynostemma Pentaphyllum tea in insulin sensitivity in type 2 diabetic patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Newly diagnosed, drug-naive patients with type 2 diabetes

• Fasting plasma glucose: 7-11 mmol/l

• HbA1C: 7-9%.

Exclusion Criteria:

• Type 1 diabetes

• Liver and kidney failure

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Insulin Resistance
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Gynostemma Pentaphyllum tea
6g/day per oral, twice a day in 10 weeks, 30 minutes before breakfast and dinner
• Placebo tea
6g/day per oral, twice a day in 10 weeks, 30 minutes before breakfast and dinner

Locations

Country	Name	City	State
Vietnam	National Institute of Gerontology	Hanoi
Vietnam	National Institute of Gerontology, HMU	Hanoi

Sponsors (3)

Lead Sponsor	Collaborator
Hanoi Medical University	Karolinska Institutet, Swedish International Development Cooperation Agency (SIDA)

Country where clinical trial is conducted

Vietnam, 

References & Publications (4)

Hoa NK, Norberg A, Sillard R, Van Phan D, Thuan ND, Dzung DT, Jörnvall H, Ostenson CG. The possible mechanisms by which phanoside stimulates insulin secretion from rat islets. J Endocrinol. 2007 Feb;192(2):389-94. — View Citation

Hoa NK, Phan DV, Thuan ND, Ostenson CG. Screening of the hypoglycemic effect of eight Vietnamese herbal drugs. Methods Find Exp Clin Pharmacol. 2009 Apr;31(3):165-9. doi: 10.1358/mf.2009.31.3.1362514. — View Citation

Huyen VT, Phan DV, Thang P, Hoa NK, Ostenson CG. Antidiabetic effect of Gynostemma pentaphyllum tea in randomly assigned type 2 diabetic patients. Horm Metab Res. 2010 May;42(5):353-7. doi: 10.1055/s-0030-1248298. Epub 2010 Mar 8. — View Citation

Norberg A, Hoa NK, Liepinsh E, Van Phan D, Thuan ND, Jörnvall H, Sillard R, Ostenson CG. A novel insulin-releasing substance, phanoside, from the plant Gynostemma pentaphyllum. J Biol Chem. 2004 Oct 1;279(40):41361-7. Epub 2004 Jun 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fating plasma glucose, Steady state plasma glucose in Somatostatin-Insulin-Glucose Infusion Test	All subjects participated in Somatostatin-Insulin-Glucose Infusion Test (SIGIT), lasting 150 minutes, performed at 8am after an 8-10h overnight fast with only tap water allowed ad libitum. Somatostatin was used to suppress endogenous insulin release, thereby allowing estimation of sensitivity to exogenously administered insulin by measuring blood glucose value at 90, 120 and 150 minute of the test (SIGIT mean).	10 weeks	No
Secondary	Liver enzymes (ALT, AST)		10 weeks	Yes
Secondary	Kidney function (S-creatinine, S-BUN)		10 weeks	Yes
Secondary	Plasma lipids (TG, Cholesterol, HDL-, LDL-)		10 weeks	No
Secondary	Blood pressure		10 weeks	Yes
Secondary	Body weight (BMI, hip-waist ratio)		10 weeks	No