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Examining Genetic Influence on Response to Beta-Blocker Medications in People With Type 2 Diabetes

Information source: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Atenolol (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)

Official(s) and/or principal investigator(s):
Amber L. Beitelshees, PharmD, MPH, Principal Investigator, Affiliation: University of Maryland, Baltimore County

Overall contact:
Amber L Beitelshees, PharmD, MPH, Phone: 410-706-0118, Email: abeitels@medicine.umaryland.edu

Summary

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.

Clinical Details

Official title: Uncoupling Protein Polymorphisms and Cardiometabolic Responses to Beta-Blockers

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Change in diastolic function (annular tissue velocity [Em])

Change in free fatty acid kinetics

Secondary outcome: Change in insulin sensitivity, glucose effectiveness, glucose, insulin, high-density lipoprotein (HDL), or triglycerides

Detailed description: 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.

Eligibility

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Amber L Beitelshees, PharmD, MPH, Phone: 410-706-0118, Email: abeitels@medicine.umaryland.edu

University of Maryland, Baltimore, Maryland 21201, United States; Recruiting
Alan Shuldiner, MD, Sub-Investigator
Richard Horenstein, MD, Sub-Investigator
Stephen Liggett, MD, Sub-Investigator
John C. McLenithan, PhD, Sub-Investigator
John Gottdiener, MD, Sub-Investigator
Additional Information

Starting date: December 2009
Last updated: September 10, 2010

Page last updated: August 23, 2015

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