Metabolic Effects of Stevia in Type 2 Diabetic Patients

Yaounde Central Hospital22 enrolled

Overview

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 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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Diabetes Mellitus

Interventions

Stevia rebaudiana liquid extractDIETARY_SUPPLEMENT

Sweetener made of liquid stevia self administered daily for 30 days

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

National Obesity Centre

Yaoundé, Cameroon

Outcomes

Primary Outcomes

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

Time frame: 1 month

Secondary Outcomes

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

Time frame: 1 month

Serum lipids

Change in fasting serum lipids

Time frame: 1 month

Insulin sensitivity

Change in mixed meal derived insulin sensitivity

Time frame: 1 month

Liver enzymes

Change in serum alanine amino transferase

Time frame: 1 month

Data from ClinicalTrials.gov

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