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

• ClinicalTrials.gov Identifier: NCT00786500
• Recruitment Status: Completed
• First Posted: November 6, 2008
• Last Update Posted: December 6, 2010
• Sponsor: Hanoi Medical University
• Collaborators: Karolinska Institutet; Swedish International Development Cooperation Agency (SIDA)
• Information provided by: Hanoi Medical University

Tracking Information

• First Submitted Date: November 5, 2008
• First Posted Date: November 6, 2008
• Last Update Posted Date: December 6, 2010
• Study Start Date: February 2007
• Actual Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 5, 2008)

• Fasting plasma glucose [ Time Frame: 12 weeks ]
• HbA1c (glycosylated hemoglobin) [ Time Frame: 12 weeks ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 5, 2008)

• Liver enzymes (ALT, AST) [ Time Frame: 12 weeks ]
• Kidney function (S-creatinine, S-BUN) [ Time Frame: 12 weeks ]
• Plasma lipids (TG, Cholesterol, HDL-, LDL-) [ Time Frame: 12 weeks ]
• Blood pressure [ Time Frame: 12 weeks ]
• Body weight (BMI, hip-waist ratio) [ Time Frame: 12 weeks ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Anti-diabetic Effect of Gynostemma Pentaphyllum Tea in Type 2 Diabetic Patients
• Official Title: Anti-diabetic Effect of Gynostemma Pentaphyllum Tea in Type 2 Diabetic Patients
• Brief 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.

Detailed 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.

• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Type 2 Diabetes

Intervention

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

Study Arms

• Active Comparator: Gynostemma pentaphyllum tea
  Intervention: Dietary Supplement: Gynostemma pentaphyllum tea
• Placebo Comparator: Placebo tea
  Intervention: Dietary Supplement: Placebo tea

Publications *

• Hoa NK, Norberg A, Sillard R, Van Phan D, Thuan ND, Dzung DT, Jornvall H, Ostenson CG. The possible mechanisms by which phanoside stimulates insulin secretion from rat islets. J Endocrinol. 2007 Feb;192(2):389-94. doi: 10.1677/joe.1.06948.
• Norberg A, Hoa NK, Liepinsh E, Van Phan D, Thuan ND, Jornvall 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. doi: 10.1074/jbc.M403435200. Epub 2004 Jun 25.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 5, 2008): 24
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 2007
• Actual Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Vietnam

Administrative Information

• NCT Number: NCT00786500
• Other Study ID Numbers: Diabetes II; Study 1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Hanoi Medical University
• Original Study Sponsor: Same as current

Collaborators

• Karolinska Institutet
• Swedish International Development Cooperation Agency (SIDA)

Investigators

• Study Director: Claes Goran Ostenson, MD, PhD; Karolinska Institutet

• PRS Account: Hanoi Medical University
• Verification Date: November 2008