Influence of Preprandial Metformin Administration on Carbohydrate Absorption

NCT04018105 | Completed

• 2 other identifiers: 2018_352019-001175-36
• Study Type: interventional
• Target: 1
• Locations: 0 countries
• Sites: N/A

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

Impaired Glucose Tolerance; Type2 Diabetes

Keywords

Impaired glucose tolerance; type 2 diabetes; obesity; carbohydrate absorption; metformin

Outcome Measures

Primary Outcomes (1)

• Area under the curve of D-Xylose

  During the 3 hours OGTT

Secondary Outcomes (4)

• 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

Study Arms (2)

taking metformin 30 or 60 minutes before the OGTT

EXPERIMENTAL

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

No metformin before OGTT

PLACEBO COMPARATOR

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

Interventions

Oral glucose tolerance test (OGTT) with or without metformin 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; taking metformin 30 or 60 minutes before the OGTT

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Obesity (BMI ≥30 kg/m2)
• Dysglycemia (HbA1c≥ 6,0 %)
• No anti diabetic medication

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

MeSH Terms

Conditions

Glucose Intolerance; Diabetes Mellitus, Type 2; Obesity

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• camille Marciniak, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 12, 2019
• Study Start: July 28, 2021
• Primary Completion: April 4, 2025
• Study Completion: April 5, 2025
• Last Updated: April 22, 2026

Record last verified: 2025-12