Overview

This trial is active, not recruiting.

Condition diabetes mellitus
Treatment stevia rebaudiana liquid extract
Sponsor Yaounde Central Hospital
Start date March 2016
End date July 2016
Trial size 22 participants
Trial identifier NCT02834715, CNO20161

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
Once-daily oral intake of 240 mg of Stevia liquid extract for 30 days as food supplement.
stevia rebaudiana liquid extract
Sweetener made of liquid stevia self administered daily for 30 days
(No Intervention)
No intervention, similar follow up as experimental arm to control for trial effect

Primary Outcomes

Measure
Glycaemic profile in response to mixed meal test
time frame: 1 month

Secondary Outcomes

Measure
insulin secretion in response to mixed meal test
time frame: 1 month
Serum lipids
time frame: 1 month
Insulin sensitivity
time frame: 1 month
Liver enzymes
time frame: 1 month

Eligibility Criteria

Male or female participants from 21 years up to 75 years old.

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

Additional Information

Official title Effects of Stevia on Glycaemic Profile and Insulin Secretion of Type 2 Diabetic Patients
Principal investigator Eugene Sobngwi, MD, PhD
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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Yaounde Central Hospital.