- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00786500
Anti-diabetic Effect of Gynostemma Pentaphyllum Tea in Type 2 Diabetic Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Hanoi, Vietnam
- National Institute of Gerontology, HMU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Gynostemma pentaphyllum tea
|
3 grams twice daily, orally
|
Placebo Comparator: Placebo tea
|
3 grams twice daily, orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fasting plasma glucose
Time Frame: 12 weeks
|
12 weeks
|
HbA1c (glycosylated hemoglobin)
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood pressure
Time Frame: 12 weeks
|
12 weeks
|
Liver enzymes (ALT, AST)
Time Frame: 12 weeks
|
12 weeks
|
Kidney function (S-creatinine, S-BUN)
Time Frame: 12 weeks
|
12 weeks
|
Plasma lipids (TG, Cholesterol, HDL-, LDL-)
Time Frame: 12 weeks
|
12 weeks
|
Body weight (BMI, hip-waist ratio)
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Claes Goran Ostenson, MD, PhD, Karolinska Institutet
Publications and helpful links
General Publications
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Diabetes II
- Study 1
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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