Study of Clinical Response to Acute Metformin by Leveraging Evaluations During a Mixed Meal Tolerance Test for Exploring Glycemia and GeneticS

Not Applicable

Active, not recruiting

• Conditions: Genetics; Metabolism; Type 2 Diabetes
• Interventions: Other: Mixed Meal Tolerance Test; Drug: Metformin

• Registration Number: NCT02087826
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The purpose of this research study is to examine whether specific genes (e.g. SLC16A11) affect how human beings respond to food and a medication that is commonly used to treat type 2 diabetes. The food the investigators will be studying is specially prepared to contain protein, carbohydrate, and fat. The drug the investigators are studying is metformin. The investigators hypothesize that physiological responses to the meal and to the medication will differ between carriers and non-carriers of genes associated with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-12
• Study First Submitted QC: 2014-03-13
• Study First Posted: 2014-03-14
• Study Start: 2014-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1017

Inclusion Criteria

• Adult males or non-pregnant females
• Age 18-79
• Able and willing to give consent relevant to genetic investigation

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Exclusion Criteria

• Women who are pregnant, nursing, or at risk of becoming pregnant
• Currently taking any medications used for the treatment of diabetes
• History of liver disease and/or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 3 times upper limit of normal (ULN)
• Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation
• Currently taking or intending to take during the study duration any medication known to affect glycemic parameters, such as glucocorticoids, growth hormone, or fluoroquinolones
• Contraindications to safe use of metformin, including planned radiologic or angiographic study requiring contrast within one week of the study completion
• Planned changes to any prescribed medications, specifically diuretics, during study enrollment
• Participation in any other interventional study during the study duration
• Conditions causing intestinal malabsorption, including celiac disease or a history of intestinal or gastric bypass surgery
• Dietary restrictions that would prevent consumption of a MMTT
• Objection or inability to take metformin

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Carriers of the SLC16A11 risk allele	Mixed Meal Tolerance Test	Day 1: Mixed Meal Tolerance Test Day 3-7: 500mg metformin, twice daily Day 8: Mixed Meal Tolerance Test in presence of Metformin
Carriers of the SLC16A11 risk allele	Metformin	Day 1: Mixed Meal Tolerance Test Day 3-7: 500mg metformin, twice daily Day 8: Mixed Meal Tolerance Test in presence of Metformin
Non-carriers of the SLC16A11 risk allele	Mixed Meal Tolerance Test	Day 1: Mixed Meal Tolerance Test Day 3-7: 500mg metformin, twice daily Day 8: Mixed Meal Tolerance Test in presence of Metformin
Non-carriers of the SLC16A11 risk allele	Metformin	Day 1: Mixed Meal Tolerance Test Day 3-7: 500mg metformin, twice daily Day 8: Mixed Meal Tolerance Test in presence of Metformin

Primary Outcome Measures

Name	Time	Method
Response to the Mixed Meal Tolerance Test	2 hours after the meal	Primary endpoint point: 2 hr glucose after the MMTT; Secondary endpoints: 2 hr insulin after the MMTT, change in glucose, insulin, and amino acid and lipid metabolites from baseline to 60 and 120 minutes after the MMTT; change in GLP-1 concentrations from baseline to 5,10, 15, 30, 60, and 120 minutes after the MMTT; and glucose, insulin, and GLP-1 AUC over 120 minutes

Secondary Outcome Measures

Name	Time	Method
Response to Metformin	Day 8 of the study	Primary endpoint: change in fasting glucose from Visit 1 to Visit 2; Secondary endpoints: change in fasting insulin, amino acid and lipid metabolites, GLP-1, and HOMA-IR from Visit 1 to Visit 2

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States