Metabolic Effects of Stevia in Type 2 Diabetic Patients

Diabetes Mellitus Clinical Trial

— STEDIA1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02834715
• Other study ID #: CNO20161
• Status: Completed
• Phase: N/A
• First received: July 8, 2016
• Last updated: January 23, 2017
• Start date: March 2016
• Est. completion date: August 2016

Study information

• Verified date: January 2017
• Source: Yaounde Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Dietary Supplement:
• Stevia rebaudiana liquid extract
Sweetener made of liquid stevia self administered daily for 30 days

Locations

Country	Name	City	State
Cameroon	National Obesity Centre	Yaounde

Sponsors (1)

Lead Sponsor	Collaborator
Yaounde Central Hospital

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 month
Secondary	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	1 month
Secondary	Serum lipids	Change in fasting serum lipids	1 month
Secondary	Insulin sensitivity	Change in mixed meal derived insulin sensitivity	1 month
Secondary	Liver enzymes	Change in serum alanine amino transferase	1 month