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Biguanide

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

N/A
Waitlist Available
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-79
Be older than 18 years old
Must not have
Women who are pregnant, nursing, or at risk of becoming pregnant
Currently taking any medications used for the treatment of diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 8 of the study

Summary

This trial looks at how different genes affect how humans respond to food and medication for diabetes.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Metformin may cause digestive upset like diarrhea or nausea; it might also lead to vitamin B12 deficiency over time. Rarely it could cause a serious condition called lactic acidosis especially if there are kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 79 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, nursing, or at risk of becoming pregnant.
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I am currently on medication for diabetes.
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My liver is healthy and my liver enzyme levels are not more than 3 times the normal limit.
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I am taking or plan to take medication that can affect blood sugar levels.
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I have no health issues preventing me from safely using metformin, and I am not scheduled for any contrast imaging tests within a week after the study ends.
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I plan to change my prescribed medications, including diuretics, during the study.
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I have a condition like celiac disease or had surgery that affects how my body absorbs food.
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I cannot or do not want to take metformin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 8 of the study
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 8 of the study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Response to the Mixed Meal Tolerance Test
Secondary study objectives
Response to Metformin
Other study objectives
Response to a Mixed Meal Tolerance Test after Metformin

Trial Design

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

Find a Location

Who is running the clinical trial?

Instituto Carlos Slim de la SaludUNKNOWN
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,412,782 Total Patients Enrolled
3 Trials studying Metabolism
253,639 Patients Enrolled for Metabolism
Broad InstituteOTHER
20 Previous Clinical Trials
15,313 Total Patients Enrolled
Laura N Brenner, MDStudy DirectorMassachusetts General Hospital
Jose C Florez, MDStudy DirectorMassachusetts General Hospital

Media Library

Metformin (Biguanide) Clinical Trial Eligibility Overview. Trial Name: NCT02087826 — N/A
Metabolism Research Study Groups: Carriers of the SLC16A11 risk allele, Non-carriers of the SLC16A11 risk allele
Metabolism Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT02087826 — N/A
Metformin (Biguanide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02087826 — N/A
~87 spots leftby Dec 2025
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