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| ID | Type | Description | Link |
|---|---|---|---|
| Study 1 |
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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
| Swedish International Development Cooperation Agency (SIDA) | OTHER_GOV |
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The aim of the present study was to investigate the long-term effects on blood glucose concentrations and possible adverse effects of an extract of Gynostemma pentaphyllum (GP). This is a plant growing in the mountain regions of Northern Vietnam and previously being used in traditional medicine. The GP extract, or placebo, was randomized to newly diagnosed patients with type 2 diabetes and administered as a "tea", 3 g two times daily during 12 weeks. All patients received instructions regarding diet and physical exercise. Oral glucose tolerance tests were performed at baseline and then every 4 weeks, and blood tests were taken with the purpose to monitor lipids, kidney and liver function, body weight and blood pressure.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gynostemma pentaphyllum tea | Active Comparator |
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| Placebo tea | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gynostemma pentaphyllum tea | Dietary Supplement | 3 grams twice daily, orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Fasting plasma glucose | 12 weeks | |
| HbA1c (glycosylated hemoglobin) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Liver enzymes (ALT, AST) | 12 weeks | |
| Kidney function (S-creatinine, S-BUN) | 12 weeks | |
| Plasma lipids (TG, Cholesterol, HDL-, LDL-) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claes Goran Ostenson, MD, PhD | Karolinska Institutet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Gerontology, HMU | Hanoi | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17283239 | Background | 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. | |
| 15220351 | Background | 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. |
| Label | URL |
|---|---|
| Publication on the study | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo tea |
| Dietary Supplement |
3 grams twice daily, orally |
|
| 12 weeks |
| Blood pressure | 12 weeks |
| Body weight (BMI, hip-waist ratio) | 12 weeks |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |