Common Variation at SLC16A11 and Other Genes on the Response to a Mixed Meal Tolerance Test | RxWiki

Common Variation at SLC16A11 and Other Genes on the Response to a Mixed Meal Tolerance Test

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Genetics Metabolism Type 2 Diabetes
Intervention	Other: Mixed Meal Tolerance Test Drug: Metformin
Phase	N/A
Sponsor	Massachusetts General Hospital
Responsible Party	Massachusetts General Hospital
ClinicalTrials.gov Identifier	NCT02087826
First Received	March 12, 2014
Last Updated	April 14, 2014
Last verified	April 2014

Tracking Information[ + expand ][ + ]

First Received Date	March 12, 2014
Last Updated Date	April 14, 2014
Start Date	April 2014
Estimated Primary Completion Date	January 2017
Current Primary Outcome Measures	Response to the Mixed Meal Tolerance Test [Time Frame: 2 hours after the meal] [Designated as safety issue: No]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
Current Secondary Outcome Measures	Response to Metformin [Time Frame: Day 8 of the study] [Designated as safety issue: No]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

Descriptive Information[ + expand ][ + ]

Brief Title	Common Variation at SLC16A11 and Other Genes on the Response to a Mixed Meal Tolerance Test
Official Title	A Study to Understand the Influence of Common Variation at SLC16A11 and Other Genes on the Physiologic Response to a Mixed Meal Tolerance Test (SIGMA2 MGH)
Brief 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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	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. Other Names: Glucophage Glumetza Glucophage XR Fortamet
Study Arm (s)	Active Comparator: Carriers of the SLC16A11 risk allele Day 1: Mixed Meal Tolerance Test Day 3-7: 500mg metformin, twice daily Day 8: Mixed Meal Tolerance Test in presence of Metformin Placebo Comparator: Non-carriers of the SLC16A11 risk allele Day 1: Mixed Meal Tolerance Test Day 3-7: 500mg metformin, twice daily Day 8: Mixed Meal Tolerance Test in presence of Metformin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	100
Estimated Completion Date	January 2017
Estimated Primary Completion Date	January 2017
Eligibility Criteria	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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Contact: Nicole Landa, MPH 6176434985 nlanda@partners.org
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT02087826
Other Study ID Numbers	2014P000255
Has Data Monitoring Committee	Yes
Information Provided By	Massachusetts General Hospital
Study Sponsor	Massachusetts General Hospital
Collaborators	Instituto Carlos Slim de la Salud Broad Institute of Harvard and MIT
Investigators	Principal Investigator: Geoffrey A Walford, MD Massachusetts General Hospital
Verification Date	April 2014

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