Diabetes Mellitus, Type 2 | Examining Genetic Influence on Response to Beta-Blocker Medications in People With Type 2 Diabetes
Diabetes Mellitus, Type 2 research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - Type 2 diabetes for more than 1 year before study entry Exclusion Criteria: - Insulin therapy - Treatment with any beta-blocker in the 30 days before study entry - Asthma - Chronic obstructive pulmonary disease (COPD) - Greater than first degree heart block - Heart rate less than 60 bpm - Systolic blood pressure less than 90 mm Hg - Raynaud's phenomenon - Known history of angina, heart attack, heart failure, coronary revascularization, or automatic implantable cardioverter defibrillators - Pregnant - Creatinine clearance less than 35 ml/min - Hematologic dysfunction (white blood cell[WBC] count less than 3000 or hematocrit less than 28%) - Allergy to amide anesthetics
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Diabetes Mellitus, Type 2
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Atenolol12.5 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
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
AtenololParticipants will receive atenolol for 8 weeks.
Start Date: December 2009
Completed Date: June 2013
Phase: Phase 4
Primary Outcome: Change in diastolic function (annular tissue velocity [Em])
Secondary Outcome: Change in insulin sensitivity, glucose effectiveness, glucose, insulin, high-density lipoprotein (HDL), or triglycerides
Study sponsors, principal investigator, and references
Principal Investigator: Amber L. Beitelshees, PharmD, MPH
Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Collaborator: University of Maryland