Anti-diabetic Effect of Gynostemma Pentaphyllum Tea in Type 2 Diabetic Patients

Type 2 Diabetes Clinical Trial

Official title:

Anti-diabetic Effect of Gynostemma Pentaphyllum Tea in Type 2 Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00786500
• Other study ID #: Diabetes II
• Secondary ID: Study 1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 5, 2008
• Last updated: December 3, 2010
• Start date: February 2007
• Est. completion date: December 2007

Study information

• Verified date: November 2008
• Source: Hanoi Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of HealthSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

The aim of the present study was to investigate the long-term effects on blood glucose concentrations and possible adverse effects of an extract of Gynostemma pentaphyllum (GP). This is a plant growing in the mountain regions of Northern Vietnam and previously being used in traditional medicine. The GP extract, or placebo, was randomized to newly diagnosed patients with type 2 diabetes and administered as a "tea", 3 g two times daily during 12 weeks. All patients received instructions regarding diet and physical exercise. Oral glucose tolerance tests were performed at baseline and then every 4 weeks, and blood tests were taken with the purpose to monitor lipids, kidney and liver function, body weight and blood pressure.

Description:

In Vietnam, herbal extracts have been used as a long-standing tradition to treat diabetic patients, but effects of these extracts have not been studied adequately. Based on previous results in experimental animals, we have selected the plant Gynostemma pentaphyllum (GP), which grows in the mountain region of Northern Vietnam. GP extract had a hypoglycemic effect on mice and rats, and was shown to contain a substance, phanoside, which stimulates insulin secretion. In addition, GP has been shown to reduce both hyperglycemia and hyperlipidemia in diabetic Zucker fatty rats.

The present study aimed at investigate effects of GP extract, administered as a "tea", and compared with placebo in a randomized, double-blind trial in drug-naive patients with newly diagnosed type 2 diabetes. All patients also received instructions about diet and physical exercise. In addition to monitoring effects on plasma glucose regulation, we also studied possible effects on plasma lipids, kidney and liver function as well as body weight and blood pressure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2007
• Est. primary completion date: September 2007
• 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 (FPG) 7.0-14.0 mmol/l

• HbA1c > 6%

Exclusion Criteria:

• Type 1 diabetes

• Liver failure

• Kidney Failure

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Gynostemma pentaphyllum tea
3 grams twice daily, orally
• Placebo tea
3 grams twice daily, orally

Locations

Country	Name	City	State
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 (2)

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

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	Fasting plasma glucose		12 weeks	No
Primary	HbA1c (glycosylated hemoglobin)		12 weeks	No
Secondary	Liver enzymes (ALT, AST)		12 weeks	Yes
Secondary	Kidney function (S-creatinine, S-BUN)		12 weeks	Yes
Secondary	Plasma lipids (TG, Cholesterol, HDL-, LDL-)		12 weeks	No
Secondary	Blood pressure		12 weeks	Yes
Secondary	Body weight (BMI, hip-waist ratio)		12 weeks	No

External Links

•   Publication on the study