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Anti-Diabetic Effect of Gynostemma Pentaphyllum Tea as add-on Therapy With Sulfonylureas in Type 2 Diabetic Patients

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 1
Locations
Vietnam
Study Type
Interventional
Intervention
GP group
Placebo group
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, add-on

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 (FPG)9.0-14.0 mmol/L
  • HbA1C 9-13%

Exclusion Criteria:

  • Type 1 diabetes
  • Liver failure
  • Kidney failure

Sites / Locations

  • National Institute of Gerontology, HMU

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo group

GP group

Arm Description

Gliclazide + Placebo tea

Gliclazide + Gynostemma pentaphyllum tea

Outcomes

Primary Outcome Measures

fasting plasma glucose
HbA1C (glycosylated hemoglobin)

Secondary Outcome Measures

liver enzymes (AST, ALT)
kidney function (S-creatinine, S-BUN)
plasma lipids (TG, Cholesterol, HDL-, LDL-)
blood pressure
body weight (BMI, hip-weight ratio)

Full Information

First Posted
December 15, 2008
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
NCT00808860
Brief Title
Anti-Diabetic Effect of Gynostemma Pentaphyllum Tea as add-on Therapy With Sulfonylureas in Type 2 Diabetic Patients
Official Title
Anti-Diabetic Effect of Gynostemma Pentaphyllum Tea as add-on Therapy With Sulfonylureas in Type 2 Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
December 2008 (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 present study aimed at investigating effect of Gynostemma pentapyllum (GP) extract, administered as a "tea", as add-on therapy with Sulfonylurea (SU) in drug-naive patients with newly diagnosed type 2 diabetes. After screening, all patients received gliclazide MR 30mg and instruction regarding diet and physical exercise for 12 weeks. After 4 weeks treated with gliclazide MR 30mg, the patients was randomized to additional GP tea or placebo tea, 3 g twice daily during 8 weeks. Oral glucose tolerance tests were performed at baseline, after 4 and 12 weeks. Blood tests were taken with the purpose to monitor lipids, kidney and liver function.
Detailed Description
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 animal, the investigators have selected the plant Gynostemma pentapyllum (GP), which grows in the mountain region of Northern Vietnam. GP extract had a hypoglycemic effect on mice and rat. In addition, GP has been shown to reduce both hyperglycemia and hyperlipidemia in diabetic Zucker fatty rats.The present study aimed at investigating effect of Gynostemma pentapyllum (GP) extract, administered as a "tea", as add-on therapy with Sulfonylurea (SU) in drug-naive patients with newly diagnosed type 2 diabetes.In addition to monitoring effects plasma glucose regulation, the investigators also studied possible effects on plasma lipids, kidney and liver function as well as body weight and blood pressure.

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, add-on

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Gliclazide + Placebo tea
Arm Title
GP group
Arm Type
Active Comparator
Arm Description
Gliclazide + Gynostemma pentaphyllum tea
Intervention Type
Dietary Supplement
Intervention Name(s)
GP group
Intervention Description
Gliclazide MR 30mg once a day, orally Gynostemma pentaphyllum tea 3 grams twice daily, orally
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo group
Intervention Description
Gliclazide MR 30mg once a day, orally Placebo tea 3 grams twice daily, orally
Primary Outcome Measure Information:
Title
fasting plasma glucose
Time Frame
12 weeks
Title
HbA1C (glycosylated hemoglobin)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
liver enzymes (AST, ALT)
Time Frame
12 weeks
Title
kidney function (S-creatinine, S-BUN)
Time Frame
12 weeks
Title
plasma lipids (TG, Cholesterol, HDL-, LDL-)
Time Frame
12 weeks
Title
blood pressure
Time Frame
12 weeks
Title
body weight (BMI, hip-weight ratio)
Time Frame
12 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 (FPG)9.0-14.0 mmol/L HbA1C 9-13% Exclusion Criteria: Type 1 diabetes Liver failure Kidney failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claes-Goran Ostenson, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Director
Facility Information:
Facility Name
National Institute of Gerontology, HMU
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
background
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
background
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
result
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
result

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Anti-Diabetic Effect of Gynostemma Pentaphyllum Tea as add-on Therapy With Sulfonylureas in Type 2 Diabetic Patients

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