Primary outcomeMean· Baseline and 3 months
Peak Oxygen Consumption (VO2 Peak)
| Group | Value (milliliters per kilogram per minute) | Spread |
|---|---|---|
| Exenatide | 16.6 | 1.1 |
| Placebo | 16.1 | 1.1 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataImpact of Exenatide on Cardiovascular Exercise Performance in Type 2 Diabetes
Short name Exenatide
NCTNCT01364584 (opens ClinicalTrials.gov in a new tab)Other id10-0438
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 23 participants (actual)
- Sponsor
- University of Colorado, Denver · Other
- Design
- Randomized · Double masking
- Countries
1 country
United States
- Start
- Oct 2010
- Primary completion
- Dec 2014
- Completion
- Dec 2014
- First posted
- 2 Jun 2011 (estimated)
- Last update posted
- 12 Jul 2023
- Conditions
- Type 2 Diabetes
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201020112012201320142015
- N/A
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- ExenatideDrug
- PlaceboDrug
Arms2
Experimental
Exenatide
Pre-dosed inject-able pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months
Placebo comparator
Placebo
Pre-dosed inject-able pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months
Primary outcomes1
Outcomes the sponsor listed as primary.
Peak Oxygen Consumption (VO2 Peak)
Time frame · Baseline and 3 months
Registry description
Subjects' peak oxygen consumption (VO2 peak) will be tested on a stationary bike before and after 3 months of study medication or placebo.
Secondary outcomes(14)
Oxygen Uptake Kinetics Steady State Tau
Time frame · Baseline and 3 months
Registry description
Time to steady state oxygen consumption will be assessed in subject before and after 3 months of study medication or placebo.
Change From Baseline in Arterial Stiffness
Time frame · Baseline and 3 months
Registry description
Pulse wave velocity will be measured via sphygmocor before and after 3 months of study medication or placebo.
Change From Baseline in Peak Dilation of Brachial Artery Diameter
Time frame · Baseline and 3 months
Registry description
Change in the response of the brachial artery to hyperemia will be assessed before and after 3 months of study medication or placebo.
Change in (Non-invasively Measured) Deoxygenated Hemoglobin Concentration in the Vastus Lateralis During Exercise
Time frame · Baseline and 3 months
Registry description
Deoxygenated hemoglobin concentration will be measured using near-infrared spectroscopy during sub-maximal exercise before and after 3 months of study drug administration.
Echocardiographic Measures - Circumferential Strain
Time frame · Baseline and 3 months
Registry description
Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Echocardiographic Measures - Longitudinal Strain
Time frame · Baseline and 3 months
Registry description
Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Echocardiographic Measures - Stroke Volume
Time frame · Baseline and 3 months
Registry description
Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Echocardiographic Measures - Mitral Valve E Wave Velocity
Time frame · Baseline and 3 months
Registry description
Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Echocardiographic Measures - Mitral Valve E:A Wave Velocity
Time frame · Baseline and 3 months
Registry description
Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Echocardiographic Measures - Mitral Valve Deceleration Time
Time frame · Baseline and 3 months
Registry description
Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Echocardiographic Measures - Septal E'
Time frame · Baseline and 3 months
Registry description
Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Echocardiographic Measures - Septal E:E'
Time frame · Baseline and 3 months
Registry description
Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Echocardiographic Measures - Lateral E'
Time frame · Baseline and 3 months
Registry description
Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Echocardiographic Measures - Lateral E:E'
Time frame · Baseline and 3 months
Registry description
Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline and 3 months
Oxygen Uptake Kinetics Steady State Tau
| Group | Value (seconds) | Spread |
|---|---|---|
| Exenatide | 71.4 | 8.5 |
| Placebo | 67.2 | 2.7 |
Secondary outcomeMean· Baseline and 3 months
Change From Baseline in Arterial Stiffness
| Group | Value (meters/second) | Spread |
|---|---|---|
| Exenatide | -1.23 | 1.27 |
| Placebo | 0.37 | 0.89 |
Secondary outcomeMean· Baseline and 3 months
Change From Baseline in Peak Dilation of Brachial Artery Diameter
| Group | Value (millimeters) | Spread |
|---|---|---|
| Exenatide | 0.193 | 0.045 |
| Placebo | 0.192 | 0.046 |
Secondary outcome· Baseline and 3 months
Change in (Non-invasively Measured) Deoxygenated Hemoglobin Concentration in the Vastus Lateralis During Exercise
| Group | Value |
|---|---|
| Exenatide | not posted |
| Placebo | not posted |
Secondary outcomeMean· Baseline and 3 months
Echocardiographic Measures - Circumferential Strain
| Group | Value (% difference in circumferences) | Spread |
|---|---|---|
| Exenatide | -25.6 | 1.78 |
| Placebo | -22.6 | 1.4 |
Secondary outcomeMean· Baseline and 3 months
Echocardiographic Measures - Longitudinal Strain
| Group | Value (% difference in lengths) | Spread |
|---|---|---|
| Exenatide | -18.5 | 1.2 |
| Placebo | -18.3 | 0.8 |
Secondary outcomeMean· Baseline and 3 months
Echocardiographic Measures - Stroke Volume
| Group | Value (mL/beat) | Spread |
|---|---|---|
| Exenatide | 93.3 | 2.8 |
| Placebo | 80.7 | 1.9 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| ExenatidePre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID) | – | 3 / 11 | 0 / 11 |
| PlaceboPre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID | – | 0 / 12 | 0 / 12 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 45 Years up to 70 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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