NCT02834715

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

July 8, 2016

Last Update Submit

January 23, 2017

Conditions

Diabetes Mellitus

Keywords

DiabetesSteviainsulin secretioninsulin sensitivitySweetener

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • insulin secretion in response to mixed meal test

    1 month

  • Serum lipids

    1 month

  • Insulin sensitivity

    1 month

  • Liver enzymes

    1 month

Study Arms (2)

Stevia

EXPERIMENTAL

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

Dietary Supplement: Stevia rebaudiana liquid extract

Control

NO INTERVENTION

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

Interventions

Stevia rebaudiana liquid extractDIETARY_SUPPLEMENT

Sweetener made of liquid stevia self administered daily for 30 days

Stevia

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Known type 2 diabetes
  • No acute complication of diabetes
  • HbA1C≤ 8%

You may not qualify if:

  • Serum ALAT \>3N,
  • MDRD estimated creatinine clearance \<60ml/min
  • Tobacco smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Obesity Centre

Yaoundé, Cameroon

Location

MeSH Terms

Conditions

Diabetes MellitusInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Eugene Sobngwi, MD, PhD

    University of Yaoundé 1 and Yaoundé Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 8, 2016

First Posted

July 15, 2016

Study Start

March 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

January 24, 2017

Record last verified: 2017-01

Locations

CA(1)