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

Mass General Brigham

Status: Active, not recruiting

Conditions: Metabolism; Genetics; Type 2 Diabetes

Treatments: Other: Mixed Meal Tolerance Test; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT02087826

2014P000255

Details and patient eligibility

About

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.

Enrollment: 1,017 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,017 participants in 2 patient groups, including a placebo group

Carriers of the SLC16A11 risk allele

Active Comparator group

Description:

Day 1: Mixed Meal Tolerance Test Day 3-7: 500mg metformin, twice daily Day 8: Mixed Meal Tolerance Test in presence of Metformin

Treatment:

Drug: Metformin

Other: Mixed Meal Tolerance Test

Non-carriers of the SLC16A11 risk allele

Placebo Comparator group

Description:

Day 1: Mixed Meal Tolerance Test Day 3-7: 500mg metformin, twice daily Day 8: Mixed Meal Tolerance Test in presence of Metformin

Treatment:

Drug: Metformin

Other: Mixed Meal Tolerance Test