Anti-Diabetic Effect of Gynostemma Pentaphyllum Tea as add-on Therapy With Sulfonylureas in Type 2 Diabetic Patients

Type 2 Diabetes Clinical Trial

Official title:

Anti-Diabetic Effect of Gynostemma Pentaphyllum Tea as add-on Therapy With Sulfonylureas in Type 2 Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00808860
• Other study ID #: Diabetes II-Study 2
• Secondary ID: Study 2
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 15, 2008
• Last updated: December 3, 2010
• Start date: February 2008
• Est. completion date: December 2008

Study information

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

Clinical Trial Summary

The present study aimed at investigating effect of Gynostemma pentapyllum (GP) extract, administered as a "tea", as add-on therapy with Sulfonylurea (SU) in drug-naive patients with newly diagnosed type 2 diabetes. After screening, all patients received gliclazide MR 30mg and instruction regarding diet and physical exercise for 12 weeks. After 4 weeks treated with gliclazide MR 30mg, the patients was randomized to additional GP tea or placebo tea, 3 g twice daily during 8 weeks. Oral glucose tolerance tests were performed at baseline, after 4 and 12 weeks. Blood tests were taken with the purpose to monitor lipids, kidney and liver function.

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 animal, the investigators have selected the plant Gynostemma pentapyllum (GP), which grows in the mountain region of Northern Vietnam. GP extract had a hypoglycemic effect on mice and rat. In addition, GP has been shown to reduce both hyperglycemia and hyperlipidemia in diabetic Zucker fatty rats.The present study aimed at investigating effect of Gynostemma pentapyllum (GP) extract, administered as a "tea", as add-on therapy with Sulfonylurea (SU) in drug-naive patients with newly diagnosed type 2 diabetes.In addition to monitoring effects plasma glucose regulation, the investigators 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: 25
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• 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)9.0-14.0 mmol/L

• HbA1C 9-13%

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:
• GP group
Gliclazide MR 30mg once a day, orally Gynostemma pentaphyllum tea 3 grams twice daily, orally
• Placebo group
Gliclazide MR 30mg once a day, 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 (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	fasting plasma glucose		12 weeks	No
Primary	HbA1C (glycosylated hemoglobin)		12 weeks	No
Secondary	liver enzymes (AST, ALT)		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-weight ratio)		12 weeks	No