Clinical trial NCT01254084: Effect of Gynostemma Pentaphyllum Tea in Insulin Sensitivity in Type 2 Diabetic Patients
Official title: Gynostemma Pentaphyllum Tea Improves Insulin Sensitivity 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;
Lead sponsor: Hanoi Medical University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Swedish International Development Cooperation Agency (SIDA)
First posted: 2010-12-06
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to investigate the effects of Gynostemma Pentaphyllum tea on insulin sensitivity in drug-naïve type 2 diabetic patients.

Detailed description: In Vietnam, traditional herbal medicines have played a major role in the management of diabetes for centuries. Gynostemma Pentaphyllum (GP) Makino (Family Cucurbitaceae) is a perennial creeping herb growing wild in the mountainous regions of Vietnam, China and some other Asian countries and was widely used in Southeast Asian countries as an herbal medicine and being beneficial for the prevention and treatment of diabetes. We have previously published the evidences that GP tea possessed anti-diabetic effect with good safety data in newly diagnosed T2D patients, and had effect on insulin sensitivity. In addition extract of GP had been shown to reduce both hyperglycemia and hyperlipidemia in diabetic Zucker Fatty rats. So the present study was to investigate the effects of Gynostemma Pentaphyllum tea in insulin sensitivity in type 2 diabetic patients.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed, drug-naive patients with type 2 diabetes
* Fasting plasma glucose: 7-11 mmol/l
* HbA1C: 7-9%.

Exclusion Criteria:

* Type 1 diabetes
* Liver and kidney failure

Primary outcomes:
measure: Fating plasma glucose, Steady state plasma glucose in Somatostatin-Insulin-Glucose Infusion Test
timeFrame: 10 weeks
Secondary outcomes:
measure: Liver enzymes (ALT, AST)
timeFrame: 10 weeks
measure: Kidney function (S-creatinine, S-BUN)
timeFrame: 10 weeks
measure: Plasma lipids (TG, Cholesterol, HDL-, LDL-)
timeFrame: 10 weeks
measure: Blood pressure
timeFrame: 10 weeks
measure: Body weight (BMI, hip-waist ratio)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: National Institute of Gerontology, HMU
city: Hanoi
country: Vietnam
facility: National Institute of Gerontology
Study officials:
affiliation: Karolinska Institutet
name: Claes-Goran Ostenson, MD, Ph.D
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, 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: 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: 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.