Metabolic Effects of Stevia in Type 2 Diabetic Patients

NCT ID: NCT02834715

Last Updated: 2017-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-08-31

Brief Summary

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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

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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

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Stevia

Once-daily oral intake of 240 mg of Stevia liquid extract for 30 days as food supplement.

Group Type EXPERIMENTAL

Stevia rebaudiana liquid extract

Intervention Type DIETARY_SUPPLEMENT

Sweetener made of liquid stevia self administered daily for 30 days

Control

No intervention, similar follow up as experimental arm to control for trial effect

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Stevia rebaudiana liquid extract

Sweetener made of liquid stevia self administered daily for 30 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yaounde Central Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sobngwi Eugene

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eugene Sobngwi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Yaoundé 1 and Yaoundé Central Hospital

Locations

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National Obesity Centre

Yaoundé, , Cameroon

Site Status

Countries

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Cameroon

Other Identifiers

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CNO20161

Identifier Type: -

Identifier Source: org_study_id

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