Influence of Preprandial Metformin Administration on Carbohydrate Absorption

Study Overview
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Brief Summary
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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.

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

Conditions
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Type2 Diabetes, Impaired Glucose Tolerance

Intervention / Treatment
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* Other: Oral glucose tolerance test (OGTT) with or without metformin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention 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<br> | Other: Oral glucose tolerance test (OGTT) with or without metformin<br>* 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.<br>|
| Placebo Comparator: No metformin before OGTT<br> | Other: Oral glucose tolerance test (OGTT) with or without metformin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Impaired glucose tolerance, type 2 diabetes, obesity, carbohydrate absorption, metformin