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Clinical Trials/NCT02834715
NCT02834715CompletedNot Applicable

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

Yaounde Central Hospital1 site in 1 country22 target enrollmentStarted: March 1, 2016Last updated:
Conditions

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

  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 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

Sponsor
Yaounde Central Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Sobngwi Eugene

Professor

Yaounde Central Hospital

Study Sites (1)

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