Examining Genetic Influence on Response to Beta-Blocker Medications in People With Type 2 Diabetes
Recruitment status was Recruiting
Beta-blockers are medications used to treat cardiovascular disease (CVD) symptoms, including high blood pressure and chest pain. People with diabetes who receive beta-blockers may experience adverse health effects, but the exact cause of why this happens remains unknown. This study will examine the genetic factors that may influence how atenolol, a beta-blocker medication, affects fat breakdown, blood sugar levels, and heart function in people with type 2 diabetes.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Uncoupling Protein Polymorphisms and Cardiometabolic Responses to Beta-Blockers|
- Change in diastolic function (annular tissue velocity [Em]) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Change in free fatty acid kinetics [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Change in insulin sensitivity, glucose effectiveness, glucose, insulin, high-density lipoprotein (HDL), or triglycerides [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Participants will receive atenolol for 8 weeks.
12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated
People with diabetes who develop CVD have worse health outcomes than people without diabetes who develop CVD. Beta-blockers are medications used to treat high blood pressure, angina (i.e., chest pain), arrhythmias, and other CVD conditions. While beta-blockers are effective at treating these conditions, they may also have damaging effects on cholesterol or glucose levels, thereby possibly lessening their ability to prevent CVD events in people with diabetes. It is important to identify which patients may not benefit from receiving beta-blocker medications. Genetic factors may influence how people respond to beta-blocker medications. The purpose of this study is to evaluate the influence of genetic variation on beta-blocker-induced changes in insulin sensitivity, fat breakdown, and heart function in people with type 2 diabetes.
This study will enroll people with type 2 diabetes. At a series of up to three baseline study visits, participants will have a blood collection, a glucose tolerance test, an echocardiogram to obtain images of the heart, and biopsies of muscle from the thigh and fat from the stomach. All participants will then receive atenolol once a day for 8 weeks. During Week 1, participants will receive a low dose of atenolol. They will then attend a study visit at the end of Week 1, and study researchers will examine how well participants are tolerating the medication. If the atenolol is well tolerated, the dose will be increased. Study researchers will call participants 1 week after any dosage changes to monitor for side effects. Blood collection will occur again at a study visit at Week 4. At Week 8, participants will then attend up to three study visits for repeat baseline testing. Participants will then be slowly tapered off of atenolol over a 1-week period.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00925119
|Contact: Amber L Beitelshees, PharmD, MPHfirstname.lastname@example.org|
|United States, Maryland|
|University of Maryland||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Sub-Investigator: Alan Shuldiner, MD|
|Sub-Investigator: Richard Horenstein, MD|
|Sub-Investigator: Stephen Liggett, MD|
|Sub-Investigator: John C. McLenithan, PhD|
|Sub-Investigator: John Gottdiener, MD|
|Principal Investigator:||Amber L. Beitelshees, PharmD, MPH||University of Maryland, Baltimore County|