Anti-Diabetic Effect of Gynostemma Pentaphyllum Tea in Type 2 Diabetic Patients - Full Text View

Sponsors and Collaborators:	Hanoi Medical University Karolinska Institutet Swedish International Developmental Agency (SIDA), Stockholm, Sweden
Information provided by:	Hanoi Medical University
ClinicalTrials.gov Identifier:	NCT00786500

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes	Dietary Supplement: Gynostemma pentaphyllum tea Dietary Supplement: Placebo tea	Phase I Phase II

MedlinePlus related topics: Diabetes Dietary Supplements

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Anti-Diabetic Effect of Gynostemma Pentaphyllum Tea in Type 2 Diabetic Patients

Further study details as provided by Hanoi Medical University:

Primary Outcome Measures:

Fasting plasma glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
HbA1c (glycosylated hemoglobin) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Liver enzymes (ALT, AST) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Kidney function (S-creatinine, S-BUN) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Plasma lipids (TG, Cholesterol, HDL-, LDL-) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Body weight (BMI, hip-waist ratio) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	February 2007
Study Completion Date:	December 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Gynostemma pentaphyllum tea: Active Comparator	Dietary Supplement: Gynostemma pentaphyllum tea 3 grams twice daily, orally
Placebo tea: Placebo Comparator	Dietary Supplement: Placebo tea 3 grams twice daily, orally

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.

Eligibility

Ages Eligible for Study:	40 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00786500

Locations

Vietnam
National Institute of Gerontology, HMU
Hanoi, Vietnam

Sponsors and Collaborators

Hanoi Medical University

Karolinska Institutet

Swedish International Developmental Agency (SIDA), Stockholm, Sweden

Investigators

Study Director:

Claes Goran Ostenson, MD, PhD

Karolinska Institute

More Information

Publications:

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.

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.

Study ID Numbers:	Diabetes II, Study 1
Study First Received:	November 5, 2008
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00786500
Health Authority:	Vietnam: Ministry of Health; Sweden: Medical Products Agency

Keywords provided by Hanoi Medical University:

Herbal medicine
Type 2 diabetes
Insulin sensitivity
Insulin secretion

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

ClinicalTrials.gov processed this record on January 16, 2009