Study to Understand the Genetics of the Acute Response to Metformin and Glipizide in Humans

2007p000193

The SUGAR-MGH investigators are studying the influence of inherited gene variants on the response to two commonly prescribed type 2 diabetes medications, metformin and glipizide. They hypothesize that variants in genes that are associated with type 2 diabetes or related traits may impact the effect of anti-diabetic medications. In addition, physiological responses to an insulin secretagogue or an insulin sensitizer may shed light on the mechanism of action of reported genetic associations.

2008-01-01

2015-12-01

2025-12-01

Active (not recruiting)

Early phase I

1033

Inclusion Criteria: * Male or non-pregnant female \> 18 years of age * Investigators will target preferentially people at risk of diabetes or requiring diabetes meds * The first tier of risk will be illustrated by one of the following variables (e.g. established type 2 diabetes on diet therapy alone, elevated random glucose in electronic medical record, PCOS, metabolic syndrome, obesity, history of gestational diabetes, etc.) * The second tier of risk will be illustrated by other features that correlate with diabetes risk, such as a history of hypertension or dyslipidemia * Otherwise healthy subjects may also be candidates for the study. * Able and willing to give consent relevant to genetic investigation Exclusion Criteria: * Pregnant, nursing or at risk of becoming pregnant * Currently taking any medications for the treatment of diabetes * Currently on metformin for any other indication (e.g. PCOS) * Onset of diabetes in a family member before age 25, with autosomal transmission of diabetes across three generations * History of liver or kidney disease * Known severe allergic reactions to sulfonamides * History of porphyria * Documented estimated glomerular filtration rate (GFR) \< 60 ml/min/1.73 m2, based on the most recent serum creatinine measurement available in the electronic medical record, and calculated by the Modification of Diet in Renal Disease equation (49) available at http://www.nephron.com/cgi-bin/MDRD_GFR.cgi * Currently taking medications known to affect glycemic parameters, such as glucocorticoids, growth hormone or fluoroquinolones * Planned radiologic or angiographic study requiring contrast within one week of completion of this study * Established coronary artery disease (CAD), defined as: * History of myocardial infarction. * History of revascularization (coronary artery bypass grafting, percutaneous coronary intervention (e.g. stenting or balloon angioplasty). * Evidence of ischemia on cardiac stress test. * Enrolled in any other interventional study at time of screening through completion of study protocol * History of bariatric surgery * History of seizures * History of stroke/CVA

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1033, 'type': 'ACTUAL'}}

2024-05-01