Metabolic Effects of Stevia in Type 2 Diabetic Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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 A mixed meal tolerance test with and without 240 mg of Stevia in a randomized order to evaluate the acute effects; An oral intake of 240 mg of Stevia within 30 days as food supplement in order to assess medium-term effects

Official Title
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Effects of Stevia on Glycaemic Profile and Insulin Secretion of Type 2 Diabetic Patients

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Stevia rebaudiana liquid extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Known type 2 diabetes Unchanged hypoglycaemic treatment for at least 3 months prior to inclusion No acute complication of diabetes HbA1C≤ 8% Exclusion Criteria: Infection up to 10 days prior to inclusion Serum ALAT >3N, MDRD estimated creatinine clearance <60ml/min Tobacco smoking

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stevia<br>Once-daily oral intake of 240 mg of Stevia liquid extract for 30 days as food supplement. | Dietary Supplement: Stevia rebaudiana liquid extract<br>* Sweetener made of liquid stevia self administered daily for 30 days<br>|
| No Intervention: Control<br>No intervention, similar follow up as experimental arm to control for trial effect | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 1 month | 
| Insulin sensitivity | Change in mixed meal derived insulin sensitivity | 1 month | 
| Liver enzymes | Change in serum alanine amino transferase | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Stevia, insulin secretion, insulin sensitivity, Sweetener