Influence of Preprandial Metformin Administration on Carbohydrate Absorption (METTIME)

University Hospital, Lille

Status: Not yet enrolling

Conditions: Impaired Glucose Tolerance; Type2 Diabetes

Treatments: Other: Oral glucose tolerance test (OGTT) with or without metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT04018105

2018_35

2019-001175-36 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups, including a placebo group

taking metformin 30 or 60 minutes before the OGTT

Experimental group

Treatment:

Other: Oral glucose tolerance test (OGTT) with or without metformin

No metformin before OGTT

Placebo Comparator group

Treatment:

Other: Oral glucose tolerance test (OGTT) with or without metformin