Influence of Preprandial Metformin Administration on Carbohydrate Absorption

Type2 Diabetes Clinical Trial

— METTIME  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04018105
• Other study ID #: 2018_35
• Secondary ID: 2019-001175-36
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2022
• Est. completion date: December 2024

Study information

• Verified date: August 2022
• Source: University Hospital, Lille
• Contact: Camille Marciniak, MD
• Phone: 03.20.44.67.37
• Email: camille.marciniak[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Impaired Glucose Tolerance
• Type2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve of D-Xylose		During the 3 hours OGTT
Secondary	Number of Participants with gastrointestinal side effects		During the 3 hours OGTT
Secondary	Area under the curve of blood glucose		During the 3 hours OGTT
Secondary	Area under the curve of insulin		During the 3 hours OGTT
Secondary	Area under the curve of GLP-1		During the 3 hours OGTT