Influence of Preprandial Metformin Administration on Carbohydrate Absorption (METTIME)

August 18, 2022 updated by: University Hospital, Lille

Influence of Preprandial Metformin Administration on Carbohydrate Absorption: Pilot Randomized Controlled Study

Type 2 diabetes is spreading worldwide as well as obesity. Metformin is the most prescribed antidiabetic medication. One suggested mechanism of action is by decreasing carbohydrate absorption.

It is usually recommended to take metformin during the meal to decrease gastrointestinal side effects. However, if metformin decreases carbohydrate absorption, this might not be the most efficient intake.

To study the influence of preprandial metformin administration on carbohydrate absorption, it will repeat 3 oral glucose tolerance test on obese dysglycemic patients, without metformin or with metformin administer 30 or 60 minutes before. We will also evaluate how it impacts gastrointestinal tolerance.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Obesity (BMI ≥30 kg/m2)
  • Dysglycemia (HbA1c≥ 6,0 %)
  • No anti diabetic medication

Exclusion Criteria:

  • No obesity (BMI < 30 kg/m2)
  • No dysglycemia (HbA1c <6,0%)
  • Treatment that might interfere with carbohydrate absorption (anti diabetic medication, antibiotics, probiotics, steroids)
  • Anemia (Hb <12 g/dL)
  • Organ failure
  • Inflammatory Bowel Disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: taking metformin 30 or 60 minutes before the OGTT
Other: Oral glucose tolerance test (OGTT) with or without metformin
Each participant will have 3 OGTT, one without metformin, one with metformin30 minutes before the test, one with metformin 60 minutes before the test. The order for each test will be randomized.
Placebo Comparator: No metformin before OGTT
Other: Oral glucose tolerance test (OGTT) with or without metformin
Each participant will have 3 OGTT, one without metformin, one with metformin30 minutes before the test, one with metformin 60 minutes before the test. The order for each test will be randomized.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the curve of D-Xylose
Time Frame: During the 3 hours OGTT
During the 3 hours OGTT

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with gastrointestinal side effects
Time Frame: During the 3 hours OGTT
During the 3 hours OGTT
Area under the curve of blood glucose
Time Frame: During the 3 hours OGTT
During the 3 hours OGTT
Area under the curve of insulin
Time Frame: During the 3 hours OGTT
During the 3 hours OGTT
Area under the curve of GLP-1
Time Frame: During the 3 hours OGTT
During the 3 hours OGTT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: camille Marciniak, MD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2022

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

July 10, 2019

First Submitted That Met QC Criteria

July 10, 2019

First Posted (Actual)

July 12, 2019

Study Record Updates

Last Update Posted (Actual)

August 19, 2022

Last Update Submitted That Met QC Criteria

August 18, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018_35
  • 2019-001175-36 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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