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

Type 2 Diabetes Clinical Trial

— SCRAMBLED EGGS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02087826
• Other study ID #: 2014P000255
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2014
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1017
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Genetics
• Metabolism
• Type 2 Diabetes

Intervention

Other:
• 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.

Drug:
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Broad Institute, Instituto Carlos Slim de la Salud

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Response to a Mixed Meal Tolerance Test after Metformin	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	2 hours after the meal
Primary	Response to the Mixed Meal Tolerance Test	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	2 hours after the meal
Secondary	Response to Metformin	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	Day 8 of the study