Influence of Preprandial Metformin Administration on Carbohydrate Absorption

NCT ID: NCT04018105

Last Updated: 2022-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2024-12-31

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.

Conditions

Type2 Diabetes; Impaired Glucose Tolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

taking metformin 30 or 60 minutes before the OGTT

Group Type: EXPERIMENTAL

Oral glucose tolerance test (OGTT) with or without metformin

Intervention Type: OTHER

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.

No metformin before OGTT

Group Type: PLACEBO_COMPARATOR

Oral glucose tolerance test (OGTT) with or without metformin

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

camille Marciniak, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Central Contacts

Camille Marciniak, MD

Role: CONTACT

camille.marciniak@chru-lille.fr

03.20.44.67.37 ext. +33

Other Identifiers

2019-001175-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2018_35

Identifier Type: -

Identifier Source: org_study_id