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The main aim of the study is to assess the short term and 1-month metabolic effects of Stevia rebaudiana bertoni in patients with type 2 diabetes.
This is a non-randomized clinical trial in a type 2 diabetic population aiming to investigate the effect of Stevia rebaudiana bertoni on the glycaemic and insulin secretory response to a mixed meal tolerance test, insulin sensitivity and lipid profile. The study has two arms including an intervention arm (test group) and a non-intervention arm (controls) matched for age, sex and body mass index in 2:1 ratio.
The intervention is made of two phases including
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stevia | Experimental | Once-daily oral intake of 240 mg of Stevia liquid extract for 30 days as food supplement. |
|
| Control | No Intervention | No intervention, similar follow up as experimental arm to control for trial effect |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stevia rebaudiana liquid extract | Dietary Supplement | Sweetener made of liquid stevia self administered daily for 30 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycaemic profile in response to mixed meal test | Change in blood glucose profile during a mixed meal test at baseline and after one month intervention | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| insulin secretion in response to mixed meal test | Change in serum C-peptide profile during a mixed meal test at baseline and after one month intervention | 1 month |
| Serum lipids | Change in fasting serum lipids |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugene Sobngwi, MD, PhD | University of Yaoundé 1 and Yaoundé Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Obesity Centre | Yaoundé | Cameroon |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 1 month |
| Insulin sensitivity | Change in mixed meal derived insulin sensitivity | 1 month |
| Liver enzymes | Change in serum alanine amino transferase | 1 month |
| D006946 | Hyperinsulinism |