Metformin Response During Meal Test for Type 2 Diabetes
(SCRAMBLED EGGS Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Massachusetts General Hospital

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults aged 18-79 who can consent to genetic research. It's not for those with kidney issues, contraindications to metformin, recent or planned medication changes, other study participation, intestinal malabsorption conditions, liver disease, pregnancy risk, or on diabetes medications.

Inclusion Criteria

I am an adult and not pregnant.

I am between 18 and 79 years old.

I am willing to consent to genetic testing.

Exclusion Criteria

I have a condition like celiac disease or had surgery that affects how my body absorbs food.

I am not pregnant, nursing, or at risk of becoming pregnant.

I am currently on medication for diabetes.

+8 more

Participant Groups

The study tests how genes affect responses to a special meal and metformin (a common diabetes drug). Participants will eat a mixed meal and take metformin while researchers observe differences in response between gene carriers linked to type 2 diabetes.

2Treatment groups

Active Control

Placebo Group

Group I: Carriers of the SLC16A11 risk alleleActive Control2 Interventions

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

Group II: Non-carriers of the SLC16A11 risk allelePlacebo Group2 Interventions

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

Metformin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Glucophage for: