METTIME: Influence of Preprandial Metformin Administration on Carbohydrate Absorption

Sponsor

University Hospital, Lille (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04018105

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Impaired Glucose Tolerance Type2 Diabetes	Other: Oral glucose tolerance test (OGTT) with or without metformin	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Area under the curve of D-Xylose [During the 3 hours OGTT]

Secondary Outcome Measures

Number of Participants with gastrointestinal side effects [During the 3 hours OGTT]
Area under the curve of blood glucose [During the 3 hours OGTT]
Area under the curve of insulin [During the 3 hours OGTT]
Area under the curve of GLP-1 [During the 3 hours OGTT]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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