Common Variation at SLC16A11 and Other Genes on the Response to a Mixed Meal Tolerance Test
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 79 |
| Updated: | 3/9/2019 |
| Start Date: | April 2014 |
| End Date: | March 2020 |
| Contact: | Varinderpal Kaur |
| Email: | vkaur@partners.org |
| Phone: | 617-643-5423 |
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)
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.
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.
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
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Jose C Florez, MD, PhD
Phone: 617-643-5423
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