Anti-Diabetic Effect of Gynostemma Pentaphyllum Tea as Add-on Therapy With Sulfonylureas 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:	NCT00808860

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes	Dietary Supplement: GP group Dietary Supplement: Placebo group	Phase I Phase II

MedlinePlus related topics: Diabetes Dietary Supplements

Drug Information available for: Insulin Gliclazide

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 as Add-on Therapy With Sulfonylureas 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 (AST, ALT) [ 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-weight ratio) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	25
Study Start Date:	February 2008
Study Completion Date:	December 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo group: Placebo Comparator Gliclazide + Placebo tea	Dietary Supplement: Placebo group Gliclazide MR 30mg once a day, orally Placebo tea 3 grams twice daily, orally
GP group: Active Comparator Gliclazide + Gynostemma pentaphyllum tea	Dietary Supplement: GP group Gliclazide MR 30mg once a day, orally Gynostemma pentaphyllum 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 animal, we 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, 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)9.0-14.0 mmol/L
HbA1C 9-13%

Exclusion Criteria:

Type 1 diabetes
Liver failure
Kidney failure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808860

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 of Results:

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 2, Study 2
Study First Received:	December 15, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00808860
Health Authority:	Vietnam: Ministry of Health

Keywords provided by Hanoi Medical University:

Herbal medicine
Type 2 diabetes
Gynostemma pentaphyllum Tea
Insulin sensitivity
add-on

Study placed in the following topic categories:

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

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

ClinicalTrials.gov processed this record on January 14, 2009