Clinical trial NCT00808860: Anti-Diabetic Effect of Gynostemma Pentaphyllum Tea as add-on Therapy With Sulfonylureas in Type 2 Diabetic Patients
Official title: Anti-Diabetic Effect of Gynostemma Pentaphyllum Tea as add-on Therapy With Sulfonylureas in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes
Keywords: Herbal medicine
Type 2 diabetes
Gynostemma pentaphyllum Tea
Insulin sensitivity
add-on
Lead sponsor: Hanoi Medical University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Swedish International Development Cooperation Agency (SIDA)
First posted: 2008-12-16
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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, 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.

Eligibility 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

Primary outcomes:
measure: fasting plasma glucose
timeFrame: 12 weeks
measure: HbA1C (glycosylated hemoglobin)
timeFrame: 12 weeks
Secondary outcomes:
measure: liver enzymes (AST, ALT)
timeFrame: 12 weeks
measure: kidney function (S-creatinine, S-BUN)
timeFrame: 12 weeks
measure: plasma lipids (TG, Cholesterol, HDL-, LDL-)
timeFrame: 12 weeks
measure: blood pressure
timeFrame: 12 weeks
measure: body weight (BMI, hip-weight ratio)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: National Institute of Gerontology, HMU
Study officials:
affiliation: Karolinska Institutet
name: Claes-Goran Ostenson, MD, PhD
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.
citation: 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.