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

December 3, 2010 updated by: Hanoi Medical University

Gynostemma Pentaphyllum Tea Improves Insulin Sensitivity in Type 2 Diabetic Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hanoi, Vietnam
        • National Institute of Gerontology, HMU
      • Hanoi, Vietnam
        • National Institute of Gerontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo tea
Dietary Supplement: Placebo tea 3 gram twice daily, orally
Dietary supplement: Placebo tea
6g/day per oral, twice a day in 10 weeks, 30 minutes before breakfast and dinner
Other Names:
  • Placebo extract
Active Comparator: Gynostemma pentaphyllum Tea
Gynostemma Pentaphyllum tea 3 grams twice daily, orally
Dietary supplement: Gynostemma Pentaphyllum tea
6g/day per oral, twice a day in 10 weeks, 30 minutes before breakfast and dinner
Other Names:
  • Gynostemma Pentaphyllum extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fating plasma glucose, Steady state plasma glucose in Somatostatin-Insulin-Glucose Infusion Test
Time Frame: 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).
10 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanoi Medical University

Collaborators

Karolinska Institutet
Swedish International Development Cooperation Agency (SIDA)

Investigators

  • Study Director: Claes-Goran Ostenson, MD, Ph.D, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

December 3, 2010

First Submitted That Met QC Criteria

December 3, 2010

First Posted (Estimate)

December 6, 2010

Study Record Updates

Last Update Posted (Estimate)

December 6, 2010

Last Update Submitted That Met QC Criteria

December 3, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Diabetes II-Study3
  • Study 3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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