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Anti-diabetic Effect of Gynostemma Pentaphyllum Tea in Type 2 Diabetic Patients

NCT ID: NCT00786500

Last Updated: 2010-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-12-31

Brief Summary

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The aim of the present study was to investigate the long-term effects on blood glucose concentrations and possible adverse effects of an extract of Gynostemma pentaphyllum (GP). This is a plant growing in the mountain regions of Northern Vietnam and previously being used in traditional medicine. The GP extract, or placebo, was randomized to newly diagnosed patients with type 2 diabetes and administered as a "tea", 3 g two times daily during 12 weeks. All patients received instructions regarding diet and physical exercise. Oral glucose tolerance tests were performed at baseline and then every 4 weeks, and blood tests were taken with the purpose to monitor lipids, kidney and liver function, body weight and blood pressure.

Detailed Description

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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 animals, we have selected the plant Gynostemma pentaphyllum (GP), which grows in the mountain region of Northern Vietnam. GP extract had a hypoglycemic effect on mice and rats, and was shown to contain a substance, phanoside, which stimulates insulin secretion. In addition, GP has been shown to reduce both hyperglycemia and hyperlipidemia in diabetic Zucker fatty rats.

The present study aimed at investigate effects of GP extract, administered as a "tea", and compared with placebo in a randomized, double-blind trial in drug-naive patients with newly diagnosed type 2 diabetes. All patients also received instructions about diet and physical exercise. In addition to monitoring effects on plasma glucose regulation, we also studied possible effects on plasma lipids, kidney and liver function as well as body weight and blood pressure.

Conditions

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Type 2 Diabetes

Keywords

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Herbal medicine Type 2 diabetes Insulin sensitivity Insulin secretion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Gynostemma pentaphyllum tea

Group Type ACTIVE_COMPARATOR

Gynostemma pentaphyllum tea

Intervention Type DIETARY_SUPPLEMENT

3 grams twice daily, orally

Placebo tea

Group Type PLACEBO_COMPARATOR

Placebo tea

Intervention Type DIETARY_SUPPLEMENT

3 grams twice daily, orally

Interventions

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Gynostemma pentaphyllum tea

3 grams twice daily, orally

Intervention Type DIETARY_SUPPLEMENT

Placebo tea

3 grams twice daily, orally

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed, drug-naive patients with type 2 diabetes
* Fasting plasma glucose (FPG) 7.0-14.0 mmol/l
* HbA1c \> 6%

Exclusion Criteria

* Type 1 diabetes
* Liver failure
* Kidney Failure
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Swedish International Development Cooperation Agency (SIDA)

OTHER_GOV

Sponsor Role collaborator

Hanoi Medical University

OTHER

Sponsor Role lead

Principal Investigators

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Claes Goran Ostenson, MD, PhD

Role: STUDY_DIRECTOR

Karolinska Institutet

Locations

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National Institute of Gerontology, HMU

Hanoi, , Vietnam

Site Status

Countries

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Vietnam

References

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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.

Reference Type BACKGROUND
PMID: 17283239 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15220351 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/20213586

Publication on the study

Other Identifiers

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Study 1

Identifier Type: -

Identifier Source: secondary_id

Diabetes II

Identifier Type: -

Identifier Source: org_study_id