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

NCT ID: NCT01254084

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-11-30

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes

Keywords

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Herbal medicine; Type 2 diabetes; Gynostemma pentaphyllum Tea; Insulin sensitivity;

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo tea

Dietary Supplement: Placebo tea 3 gram twice daily, orally

Group Type PLACEBO_COMPARATOR

Placebo tea

Intervention Type DIETARY_SUPPLEMENT

6g/day per oral, twice a day in 10 weeks, 30 minutes before breakfast and dinner

Gynostemma pentaphyllum Tea

Gynostemma Pentaphyllum tea 3 grams twice daily, orally

Group Type ACTIVE_COMPARATOR

Gynostemma Pentaphyllum tea

Intervention Type DIETARY_SUPPLEMENT

6g/day per oral, twice a day in 10 weeks, 30 minutes before breakfast and dinner

Interventions

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Gynostemma Pentaphyllum tea

6g/day per oral, twice a day in 10 weeks, 30 minutes before breakfast and dinner

Intervention Type DIETARY_SUPPLEMENT

Placebo tea

6g/day per oral, twice a day in 10 weeks, 30 minutes before breakfast and dinner

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Gynostemma Pentaphyllum extract Placebo extract

Eligibility Criteria

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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
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, Ph.D

Role: STUDY_DIRECTOR

Karolinska Institutet

Locations

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National Institute of Gerontology, HMU

Hanoi, , Vietnam

Site Status

National Institute of Gerontology

Hanoi, , Vietnam

Site Status

Countries

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Vietnam

References

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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.

Reference Type BACKGROUND
PMID: 20213586 (View on PubMed)

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)

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.

Reference Type BACKGROUND
PMID: 19536359 (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)

Other Identifiers

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Study 3

Identifier Type: -

Identifier Source: secondary_id

Diabetes II-Study3

Identifier Type: -

Identifier Source: org_study_id