Clinical trial

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

NCT02087826

Name

2014P000255

Description

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.

Trial arms

Trial start

2014-04-01

Estimated PCD

2023-12-01

Trial end

2024-12-01

Status

Active (not recruiting)

Treatment

Mixed Meal Tolerance Test

The meal will provide a standard amount of total calories, protein, fat, and carbohydrate to each participant at both study visits. Pre-packaged and prepared food, weighed to the nearest gram, will be used.

Arms:

Carriers of the SLC16A11 risk allele, Non-carriers of the SLC16A11 risk allele

Metformin

Metformin will be administered during this study. This medication is safely prescribed at a maximum dose of 1000 mg twice daily for the treatment or prevention of type 2 diabetes, as well as for other metabolic conditions. To minimize potential side effects of metformin (e.g., GI upset), participants will take ½ the maximum dose of this medication (500 mg twice daily) and for only 5 days. Participants will be informed of the potential side effects of metformin. They will be asked to contact study staff and discontinue the medication if symptoms are very uncomfortable.

Arms:

Carriers of the SLC16A11 risk allele, Non-carriers of the SLC16A11 risk allele

Other names:

Glucophage, Glumetza, Glucophage XR, Fortamet

Size

1017

Primary endpoint

Response to the Mixed Meal Tolerance Test

2 hours after the meal

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1017, 'type': 'ACTUAL'}}

Updated at

2023-03-21

1 organization

1 drug

3 indications

Organization

Massachusetts General Hospital

Drug

Indication

Indication

Indication