Anti-diabetic Effect of Gynostemma Pentaphyllum Tea in Type 2 Diabetic Patients
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ClinicalTrials.gov Identifier: NCT00786500 |
Recruitment Status :
Completed
First Posted : November 6, 2008
Last Update Posted : December 6, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes | Dietary Supplement: Gynostemma pentaphyllum tea Dietary Supplement: Placebo tea | Phase 1 Phase 2 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Anti-diabetic Effect of Gynostemma Pentaphyllum Tea in Type 2 Diabetic Patients |
Study Start Date : | February 2007 |
Actual Primary Completion Date : | September 2007 |
Actual Study Completion Date : | December 2007 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Gynostemma pentaphyllum tea |
Dietary Supplement: Gynostemma pentaphyllum tea
3 grams twice daily, orally |
Placebo Comparator: Placebo tea |
Dietary Supplement: Placebo tea
3 grams twice daily, orally |
- Fasting plasma glucose [ Time Frame: 12 weeks ]
- HbA1c (glycosylated hemoglobin) [ Time Frame: 12 weeks ]
- Liver enzymes (ALT, AST) [ Time Frame: 12 weeks ]
- Kidney function (S-creatinine, S-BUN) [ Time Frame: 12 weeks ]
- Plasma lipids (TG, Cholesterol, HDL-, LDL-) [ Time Frame: 12 weeks ]
- Blood pressure [ Time Frame: 12 weeks ]
- Body weight (BMI, hip-waist ratio) [ Time Frame: 12 weeks ]
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Ages Eligible for Study: | 40 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00786500
Vietnam | |
National Institute of Gerontology, HMU | |
Hanoi, Vietnam |
Study Director: | Claes Goran Ostenson, MD, PhD | Karolinska Institutet |
Publications:
ClinicalTrials.gov Identifier: | NCT00786500 |
Other Study ID Numbers: |
Diabetes II Study 1 |
First Posted: | November 6, 2008 Key Record Dates |
Last Update Posted: | December 6, 2010 |
Last Verified: | November 2008 |
Herbal medicine Type 2 diabetes Insulin sensitivity Insulin secretion |
Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |