Metformin Response During Meal Test for Type 2 Diabetes

(SCRAMBLED EGGS Trial)

Overseen By Cristina Quintero

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 5 days

1017 Participants Needed

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.

Research Team

Laura N Brenner, MD

Principal Investigator

Massachusetts General Hospital

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants undergo a Mixed Meal Tolerance Test to assess baseline glucose and insulin response

1 day

1 visit (in-person)

Treatment

Participants receive 500mg metformin twice daily from Day 3 to Day 7

5 days

Daily medication administration

Post-Treatment Assessment

Participants undergo a Mixed Meal Tolerance Test in the presence of Metformin to assess changes in glucose and insulin response

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Metformin

Trial Overview 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.

Participant Groups

Group I: Carriers of the SLC16A11 risk allele Active Control 2 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 allele Placebo Group 2 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:

• Type 2 diabetes

Approved in United States as Glucophage for:

• Type 2 diabetes

Approved in Canada as Glucophage for:

• Type 2 diabetes

Approved in Japan as Glucophage for:

• Type 2 diabetes

Approved in China as Glucophage for:

• Type 2 diabetes

Approved in Switzerland as Glucophage for:

• Type 2 diabetes

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Instituto Carlos Slim de la Salud

Collaborator

Trials

1

Recruited

1,000+

Broad Institute of MIT and Harvard

Collaborator

Trials

21

Recruited

16,300+

Broad Institute

Collaborator

Trials

21

Recruited

16,300+