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NCT Number: NCT02087826

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Genetics Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Metabolism Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mixed Meal Tolerance Test

Other

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.

metformin

Drug

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.

Other names: Glucophage, Glumetza, Glucophage XR, Fortamet

Primary outcomes

  1. Response to the Mixed Meal Tolerance Test

    Time frame: 2 hours after the meal

    Primary endpoint point: 2 hr glucose after the MMTT

    Secondary endpoints: 2 hr insulin after the MMTT, change in glucose, insulin, and amino acid and lipid metabolites from baseline to 60 and 120 minutes after the MMTT; change in GLP-1 concentrations from baseline to 5,10, 15, 30, 60, and 120 minutes after the MMTT; and glucose, insulin, and GLP-1 AUC over 120 minutes

Secondary outcomes

  1. Response to Metformin

    Time frame: Day 8 of the study

    Primary endpoint: change in fasting glucose from Visit 1 to Visit 2

    Secondary endpoints: change in fasting insulin, amino acid and lipid metabolites, GLP-1, and HOMA-IR from Visit 1 to Visit 2

Other outcomes

  1. Response to a Mixed Meal Tolerance Test after Metformin

    Time frame: 2 hours after the meal

    Primary endpoint point: 2 hr glucose after the MMTT

    Secondary endpoints: 2 hr insulin after the MMTT, change in glucose, insulin, and amino acid and lipid metabolites from baseline to 60 and 120 minutes after the MMTT; glucose, insulin, and GLP-1 AUC over 120 minutes; and intra-individual change in the above variables from Visit 1 to Visit 2

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Broad Institute of MIT and Harvard
  • Instituto Carlos Slim de la Salud

Registry information

Official study title

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

Acronym: SCRAMBLED EGGS

Important dates

Study start
2014
Primary completion
2026
Study completion
2026
First posted
Mar 14, 2014
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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