Clinical trial NCT02087826: Study of Clinical Response to Acute Metformin By Leveraging Evaluations During a Mixed Meal Tolerance Test for Exploring Glycemia and GeneticS
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Genetics
Metabolism
Type 2 Diabetes
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Instituto Carlos Slim de la Salud
name: Broad Institute of MIT and Harvard
First posted: 2014-03-14
Enrollment: 1017
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Response to the Mixed Meal Tolerance Test
timeFrame: 2 hours after the meal
Secondary outcomes:
measure: Response to Metformin
timeFrame: Day 8 of the study
Other outcomes:
measure: Response to a Mixed Meal Tolerance Test after Metformin
timeFrame: 2 hours after the meal
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Laura N Brenner, MD
role: STUDY_DIRECTOR
References: