Impact of Exenatide on Cardiovascular Exercise Performance in Type 2 Diabetes

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Previous research in our lab and others has established that type 2 diabetes (T2D) is associated with significantly impaired functional exercise capacity, a factor which is potentially associated with an increased risk of cardiovascular disease in those with type 2 diabetes. Of great concern, the majority of people with type 2 diabetes are sedentary and one possible reason may be that exercise, even at low levels, is perceived as being a harder effort than for nondiabetic people. Thus, treatments that may motivate patients with type 2 diabetes to be more physically active have great potential benefit.

Recent observational studies suggest that glucagon-like peptide-1 agents, such as exenatide, may have a beneficial effect on endothelial and cardiac function. Because these two factors have been shown to be associated with exercise dysfunction in type 2 diabetes, the investigators hypothesize that exenatide may improve exercise capacity in those with type 2 diabetes. The aims of this study are to (1) assess whether exenatide will improve functional exercise capacity in persons with type 2 diabetes and (2) investigate the effect of exenatide on specific metabolic, endothelial, cardiac and peripheral circulatory measures of function related to changes in exercise capacity. The Investigators primary hypothesis is that exenatide will improve functional exercise capacity in people with type 2 diabetes. Having a drug that improves exercise capacity could motivate patients to exercise more and hence be a significant benefit.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborators: Amylin Pharmaceuticals, LLC.; Eli Lilly and Company
• Treatments: Exenatide

Criteria

Inclusion Criteria

• Men and women between the ages of 45 and 70 years of age

• Diagnosed with uncomplicated type 2 diabetes

• Sedentary persons (exercising not more than one time per week)

• Females who are post-menopausal

• BMI must be less than 35

• Subjects must be taking metformin for diabetes control and may also be on sulfonylurea drugs or meglitinides

• Glycosylated hemoglobin (HbA1C) <9%

• Non-smokers or former smokers who have quit for at least 1 year

• Absence of comorbid conditions

• Resting systolic blood pressure < 190, Resting diastolic blood pressure < 95

Exclusion Criteria

• People with type 2 diabetes (T2D) taking oral medications, other than metformin or sulfonylurea drugs or meglitinides, to control their diabetes.

• Persons treated with insulin will be excluded

• People who are currently smoking or have not quit for at least one year

• Peripheral neuropathy

• Regional wall motion abnormalities

• Left ventricular systolic dysfunction

• Ischemic heart disease (abnormal resting or exercise electrocardiogram)

• Presence of angina that would limit exercise performance

• Pulmonary problems that would limit exercise performance

• Systolic blood pressure >190 mmHg at rest or >250 mmHg with exercise or diastolic pressure >95 mmHg at rest or >115 mmHg with exercise

• Persons with autonomic dysfunction (>20 mm fall in upright BP without a change in heart rate)

• Proteinuria (urine protein >200 mg/dl) or a creatinine > 2.0 mg/dl

• Renal disease

• Persons with peripheral arterial disease

• Persons with a history of pancreatitis