N/A
N=23
Impact of Exenatide on Cardiovascular Exercise Performance in Type 2 Diabetes
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01364584 ↗Enrolled (actual)
23
Serious AEs
13.0%
Results posted
Jul 2018
Primary outcome: Primary: Peak Oxygen Consumption (VO2 Peak) — 16.6; 16.1 milliliters per kilogram per minute
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exenatide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Oxygen Consumption (VO2 Peak) |
16.6; 16.1 | — |
| SECONDARY Oxygen Uptake Kinetics Steady State Tau |
71.4; 67.2 | — |
| SECONDARY Change From Baseline in Arterial Stiffness |
-1.23; 0.37 | — |
| SECONDARY Change From Baseline in Peak Dilation of Brachial Artery Diameter |
0.193; 0.192; 0.226; 0.151 | — |
| SECONDARY Change in (Non-invasively Measured) Deoxygenated Hemoglobin Concentration in the Vastus Lateralis During Exercise |
— | — |
| SECONDARY Echocardiographic Measures - Circumferential Strain |
-25.6; -22.6 | — |
| SECONDARY Echocardiographic Measures - Longitudinal Strain |
-18.5; -18.3 | — |
| SECONDARY Echocardiographic Measures - Stroke Volume |
93.3; 80.7 | — |
| SECONDARY Echocardiographic Measures - Mitral Valve E Wave Velocity |
0.61; 0.78 | — |
| SECONDARY Echocardiographic Measures - Mitral Valve E:A Wave Velocity |
0.85; 0.82 | — |
| SECONDARY Echocardiographic Measures - Mitral Valve Deceleration Time |
234.6; 239.8 | — |
| SECONDARY Echocardiographic Measures - Septal E' |
0.08; 0.07 | — |
| SECONDARY Echocardiographic Measures - Septal E:E' |
8.3; 12.6 | — |
| SECONDARY Echocardiographic Measures - Lateral E' |
0.09; 0.09 | — |
| SECONDARY Echocardiographic Measures - Lateral E:E' |
6.7; 8.4 | — |
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.
Eligibility 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) 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
Data sourced from ClinicalTrials.gov (NCT01364584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.