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Completed

NCT Number: NCT02834715

Metabolic Effects of Stevia in Type 2 Diabetic Patients

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Obesity Centre

Yaoundé, Cameroon

About this study

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

  • A mixed meal tolerance test with and without 240 mg of Stevia in a randomized order to evaluate the acute effects;
  • An oral intake of 240 mg of Stevia within 30 days as food supplement in order to assess medium-term effects

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stevia rebaudiana liquid extract

Dietary Supplement

Sweetener made of liquid stevia self administered daily for 30 days

Primary outcomes

  1. 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

  1. insulin secretion in response to mixed meal test

    Time frame: 1 month

    Change in serum C-peptide profile during a mixed meal test at baseline and after one month intervention

  2. Serum lipids

    Time frame: 1 month

    Change in fasting serum lipids

  3. Insulin sensitivity

    Time frame: 1 month

    Change in mixed meal derived insulin sensitivity

  4. Liver enzymes

    Time frame: 1 month

    Change in serum alanine amino transferase

Sponsors and collaborators

Lead sponsor

Yaounde Central Hospital

Other Gov

Registry information

Official study title

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

Acronym: STEDIA1

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 15, 2016
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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