Examining Genetic Influence on Response to Beta-Blocker Medications in People With Type 2 Diabetes
| Status: | Terminated |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 1/24/2018 |
| Start Date: | December 2009 |
| End Date: | May 2014 |
Uncoupling Protein Polymorphisms and Cardiometabolic Responses to Beta-Blockers
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.
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.
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.
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.
Inclusion Criteria:
- Type 2 diabetes
- Pre-Diabetes
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
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