Effect of Gynostemma Pentaphyllum Tea in Insulin Sensitivity in Type 2 Diabetic Patients

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: Placebo tea; Dietary Supplement: Gynostemma Pentaphyllum tea

• Registration Number: NCT01254084
• Lead Sponsor: Hanoi Medical University

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.

Study Timeline

• Status Verified: 2010-02
• Study Start: 2010-02
• Primary Completion: 2010-09
• Study Completion: 2010-11
• Study First Submitted: 2010-12-03
• Study First Submitted QC: 2010-12-03
• Last Update Submitted: 2010-12-03
• Study First Posted: 2010-12-06
• Last Update Posted: 2010-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo tea	Placebo tea	Dietary Supplement: Placebo tea 3 gram twice daily, orally
Gynostemma pentaphyllum Tea	Gynostemma Pentaphyllum tea	Gynostemma Pentaphyllum tea 3 grams twice daily, orally

Primary Outcome Measures

Name	Time	Method
Fating plasma glucose, Steady state plasma glucose in Somatostatin-Insulin-Glucose Infusion Test	10 weeks	All subjects participated in Somatostatin-Insulin-Glucose Infusion Test (SIGIT), lasting 150 minutes, performed at 8am after an 8-10h overnight fast with only tap water allowed ad libitum. Somatostatin was used to suppress endogenous insulin release, thereby allowing estimation of sensitivity to exogenously administered insulin by measuring blood glucose value at 90, 120 and 150 minute of the test (SIGIT mean).

Secondary Outcome Measures

Name	Time	Method
Liver enzymes (ALT, AST)	10 weeks
Kidney function (S-creatinine, S-BUN)	10 weeks
Plasma lipids (TG, Cholesterol, HDL-, LDL-)	10 weeks
Blood pressure	10 weeks
Body weight (BMI, hip-waist ratio)	10 weeks

Trial Locations

Locations (2)

National Institute of Gerontology; 🇻🇳 Hanoi, Vietnam

National Institute of Gerontology, HMU; 🇻🇳 Hanoi, Vietnam