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N/A N=23 Randomized Double-blind Other

Impact of Exenatide on Cardiovascular Exercise Performance in Type 2 Diabetes

Type 2 Diabetes

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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