Effects of Stevia on Glycaemic Profile and Insulin Secretion of Type 2 Diabetic Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Glycaemic profile in response to mixed meal test
Study Overview
Brief Summary
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
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 21 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Glycaemic profile in response to mixed meal test
Time Frame: 1 month
Change in blood glucose profile during a mixed meal test at baseline and after one month intervention
Secondary Outcomes
- insulin secretion in response to mixed meal test(1 month)
- Serum lipids(1 month)
- Insulin sensitivity(1 month)
- Liver enzymes(1 month)
Investigators
Sobngwi Eugene
Professor
Yaounde Central Hospital