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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 1
Locations
Vietnam
Study Type
Interventional
Intervention
Gynostemma Pentaphyllum tea
Placebo tea
Sponsored by
Hanoi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Herbal medicine; Type 2 diabetes; Gynostemma pentaphyllum Tea; Insulin sensitivity;

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Institute of Gerontology, HMU
  • National Institute of Gerontology

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo tea

Gynostemma pentaphyllum Tea

Arm Description

Dietary Supplement: Placebo tea 3 gram twice daily, orally

Gynostemma Pentaphyllum tea 3 grams twice daily, orally

Outcomes

Primary Outcome Measures

Fating plasma glucose, Steady state plasma glucose in Somatostatin-Insulin-Glucose Infusion Test
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

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

Full Information

First Posted
December 3, 2010
Last Updated
December 3, 2010
Sponsor
Hanoi Medical University
Collaborators
Karolinska Institutet, Swedish International Development Cooperation Agency (SIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01254084
Brief Title
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

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hanoi Medical University
Collaborators
Karolinska Institutet, Swedish International Development Cooperation Agency (SIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Herbal medicine; Type 2 diabetes; Gynostemma pentaphyllum Tea; Insulin sensitivity;

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo tea
Arm Type
Placebo Comparator
Arm Description
Dietary Supplement: Placebo tea 3 gram twice daily, orally
Arm Title
Gynostemma pentaphyllum Tea
Arm Type
Active Comparator
Arm Description
Gynostemma Pentaphyllum tea 3 grams twice daily, orally
Intervention Type
Dietary Supplement
Intervention Name(s)
Gynostemma Pentaphyllum tea
Other Intervention Name(s)
Gynostemma Pentaphyllum extract
Intervention Description
6g/day per oral, twice a day in 10 weeks, 30 minutes before breakfast and dinner
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo tea
Other Intervention Name(s)
Placebo extract
Intervention Description
6g/day per oral, twice a day in 10 weeks, 30 minutes before breakfast and dinner
Primary Outcome Measure Information:
Title
Fating plasma glucose, Steady state plasma glucose in Somatostatin-Insulin-Glucose Infusion Test
Description
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).
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Liver enzymes (ALT, AST)
Time Frame
10 weeks
Title
Kidney function (S-creatinine, S-BUN)
Time Frame
10 weeks
Title
Plasma lipids (TG, Cholesterol, HDL-, LDL-)
Time Frame
10 weeks
Title
Blood pressure
Time Frame
10 weeks
Title
Body weight (BMI, hip-waist ratio)
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claes-Goran Ostenson, MD, Ph.D
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Director
Facility Information:
Facility Name
National Institute of Gerontology, HMU
City
Hanoi
Country
Vietnam
Facility Name
National Institute of Gerontology
City
Hanoi
Country
Vietnam

12. IPD Sharing Statement

Citations:
PubMed Identifier
20213586
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.
Results Reference
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PubMed Identifier
17283239
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.
Results Reference
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PubMed Identifier
19536359
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.
Results Reference
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PubMed Identifier
15220351
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.
Results Reference
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Effect of Gynostemma Pentaphyllum Tea in Insulin Sensitivity in Type 2 Diabetic Patients

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