Diabetes Mellitus
Conditions
Keywords
Diabetes, Stevia, insulin secretion, insulin sensitivity, Sweetener
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 1. A mixed meal tolerance test with and without 240 mg of Stevia in a randomized order to evaluate the acute effects; 2. An oral intake of 240 mg of Stevia within 30 days as food supplement in order to assess medium-term effects
Interventions
DIETARY_SUPPLEMENTStevia rebaudiana liquid extract
Sweetener made of liquid stevia self administered daily for 30 days
Sponsors
Yaounde Central Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycaemic profile in response to mixed meal test | 1 month | Change in blood glucose profile during a mixed meal test at baseline and after one month intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum lipids | 1 month | Change in fasting serum lipids |
| insulin secretion in response to mixed meal test | 1 month | Change in serum C-peptide profile during a mixed meal test at baseline and after one month intervention |
| Insulin sensitivity | 1 month | Change in mixed meal derived insulin sensitivity |
| Liver enzymes | 1 month | Change in serum alanine amino transferase |
Countries
Cameroon
Outcome results
None listed