Type 2 DiabetesExenatideNCT01364584
Impact of Exenatide on Cardiovascular Exercise Performance in Type 2 Diabetes
A study testing Exenatide in people with Type 2 Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Exenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
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.
Read the detailed description
Subjects will come for a total of seven testing visits, including two screening visits, during which evaluations will take place. Visits are structured as follows:
Visits 1, 2 and 3 will be completed over a four-week period.
- After subjects review the study and give consent for study participation, a history and physical exam will be performed. In addition, the Low-level Physical Activity Recall (LoPAR) questionnaire, pulmonary function testing, and vital signs will be performed.
- Subjects will be asked to fast prior to visit 2. Blood and urine samples will be collected for measurement of glycosylated hemoglobin(HbA1C), fasting glucose, fasting insulin, free fatty acids and microalbuminuria (these measures will be covariates in the analyses). A dietary survey will be administered for food preferences for the three day study diet administered prior to visits 3, 4, 6 and 7. Dual Energy X-ray Absorptiometry (DXA) and body composition tests will be done to ensure that groups are weight similar (using fat-free mass). Autonomic nervous system testing, a resting electrocardiogram (EKG) and familiarization bicycle test will be performed.
- Subjects will receive a three day study diet prior to visit 3. A resting and exercise EKG will be performed on the day of the visit. Patients will have measures made of cardiac function and endothelial function on visit 3 as well using plethysmography and cardiac echo. The peak aerobic capacity (VO2max) test will be performed. Vital signs will be taken at rest.
- Randomization: Subjects will receive a three day study diet prior to visit 4. During visit four, arterial stiffness/endothelial function will be non-invasively measured by the Sphygmocor system. Subjects will have three constant-load tests to measure oxygen (VO2) kinetics where oxygen saturation (StO2) will be measured during exercise. A resting and exercise EKG and vital signs will be performed during the visit. Subjects will be randomized to either taking exenatide or placebo and all must have been taking metformin (1-2 grams /d) for at least 3 months. Exenatide will be titrated starting at 5 mcg twice per day for two weeks then moving to 10 mcg twice per day as tolerated and the placebo dose will match this titration. During the treatment phase subjects will be given a log to keep track of their blood glucose each day. Study coordinators will contact each subject weekly to obtain these values which will be checked by the study doctors and shared with the subject's primary care physician if adjustments in other medications need to be made.
- Week 4: Visit 5 will consist of a physical exam with a clinician as well as a blood draw and check of vital signs during exenatide treatment.
- Week 12: After 3 months of exenatide or placebo administration, the procedures of Visit 3 will be repeated as Visit 6. Additional testing to be performed during visit 6 include a physical exam performed by a study physician, DXA scan and body composition tests to monitor any changes in body composition (fat-free mass), blood work for lab tests listed in Visit 2 and the LoPAR questionnaire.
- Week 13: During visit 7, the testing performed during visit 4 will be repeated after 3 months of exenatide or placebo administration.
Subjects will continue exenatide or placebo treatment while completing exit testing during Weeks 12 and 13.
- Conditions
- Type 2 Diabetes
- Being tested
- Exenatide, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
Also called Byetta
Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)
PlaceboDrug
Subcutaneous injection 2.5 mcg-10 mcg BID
| Study group | Role | What they receive |
|---|---|---|
| Exenatide | Experimental | Pre-dosed inject-able pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months Receives: Drug: Exenatide |
| Placebo | Placebo comparator | Pre-dosed inject-able pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Oxygen Consumption (VO2 Peak)
Subjects' peak oxygen consumption (VO2 peak) will be tested on a stationary bike before and after 3 months of study medication or placebo.
Measured: Baseline and 3 months
Secondary outcomes (14)
Oxygen Uptake Kinetics Steady State Tau
Time to steady state oxygen consumption will be assessed in subject before and after 3 months of study medication or placebo.
Measured: Baseline and 3 months
Change From Baseline in Arterial Stiffness
Pulse wave velocity will be measured via sphygmocor before and after 3 months of study medication or placebo.
Measured: Baseline and 3 months
Change From Baseline in Peak Dilation of Brachial Artery Diameter
Change in the response of the brachial artery to hyperemia will be assessed before and after 3 months of study medication or placebo.
Measured: Baseline and 3 months
Change in (Non-invasively Measured) Deoxygenated Hemoglobin Concentration in the Vastus Lateralis During Exercise
Deoxygenated hemoglobin concentration will be measured using near-infrared spectroscopy during sub-maximal exercise before and after 3 months of study drug administration.
Measured: Baseline and 3 months
Echocardiographic Measures - Circumferential Strain
Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Measured: Baseline and 3 months
Echocardiographic Measures - Longitudinal Strain
Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Measured: Baseline and 3 months
Echocardiographic Measures - Stroke Volume
Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Measured: Baseline and 3 months
Echocardiographic Measures - Mitral Valve E Wave Velocity
Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Measured: Baseline and 3 months
Echocardiographic Measures - Mitral Valve E:A Wave Velocity
Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Measured: Baseline and 3 months
Echocardiographic Measures - Mitral Valve Deceleration Time
Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Measured: Baseline and 3 months
Echocardiographic Measures - Septal E'
Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Measured: Baseline and 3 months
Echocardiographic Measures - Septal E:E'
Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Measured: Baseline and 3 months
Echocardiographic Measures - Lateral E'
Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Measured: Baseline and 3 months
Echocardiographic Measures - Lateral E:E'
Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startOct 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Amylin Pharmaceuticals, LLC., Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Judith G Regensteiner, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364584
- Sponsor's protocol ID
- 10-0438
- Acronym
- Exenatide
- Status last verified
- Jul 2023
- First submitted
- 24 May 2011
- Last updated
- 12 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exenatide on Cardiovascular Exercise Performance in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01364584
- Acronym / sponsor ID
- Exenatide / 10-0438
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Amylin Pharmaceuticals, LLC., Eli Lilly and Company
- Study start
- Oct 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Jun 2011 (estimated)
- Results
- Posted 9 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects will come for a total of seven testing visits, including two screening visits, during which evaluations will take place. Visits are structured as follows:
Visits 1, 2 and 3 will be completed over a four-week period.
- After subjects review the study and give consent for study participation, a history and physical exam will be performed. In addition, the Low-level Physical Activity Recall (LoPAR) questionnaire, pulmonary function testing, and vital signs will be performed.
- Subjects will be asked to fast prior to visit 2. Blood and urine samples will be collected for measurement of glycosylated hemoglobin(HbA1C), fasting glucose, fasting insulin, free fatty acids and microalbuminuria (these measures will be covariates in the analyses). A dietary survey will be administered for food preferences for the three day study diet administered prior to visits 3, 4, 6 and 7. Dual Energy X-ray Absorptiometry (DXA) and body composition tests will be done to ensure that groups are weight similar (using fat-free mass). Autonomic nervous system testing, a resting electrocardiogram (EKG) and familiarization bicycle test will be performed.
- Subjects will receive a three day study diet prior to visit 3. A resting and exercise EKG will be performed on the day of the visit. Patients will have measures made of cardiac function and endothelial function on visit 3 as well using plethysmography and cardiac echo. The peak aerobic capacity (VO2max) test will be performed. Vital signs will be taken at rest.
- Randomization: Subjects will receive a three day study diet prior to visit 4. During visit four, arterial stiffness/endothelial function will be non-invasively measured by the Sphygmocor system. Subjects will have three constant-load tests to measure oxygen (VO2) kinetics where oxygen saturation (StO2) will be measured during exercise. A resting and exercise EKG and vital signs will be performed during the visit. Subjects will be randomized to either taking exenatide or placebo and all must have been taking metformin (1-2 grams /d) for at least 3 months. Exenatide will be titrated starting at 5 mcg twice per day for two weeks then moving to 10 mcg twice per day as tolerated and the placebo dose will match this titration. During the treatment phase subjects will be given a log to keep track of their blood glucose each day. Study coordinators will contact each subject weekly to obtain these values which will be checked by the study doctors and shared with the subject's primary care physician if adjustments in other medications need to be made.
- Week 4: Visit 5 will consist of a physical exam with a clinician as well as a blood draw and check of vital signs during exenatide treatment.
- Week 12: After 3 months of exenatide or placebo administration, the procedures of Visit 3 will be repeated as Visit 6. Additional testing to be performed during visit 6 include a physical exam performed by a study physician, DXA scan and body composition tests to monitor any changes in body composition (fat-free mass), blood work for lab tests listed in Visit 2 and the LoPAR questionnaire.
- Week 13: During visit 7, the testing performed during visit 4 will be repeated after 3 months of exenatide or placebo administration.
Subjects will continue exenatide or placebo treatment while completing exit testing during Weeks 12 and 13.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exenatide | Experimental | Drug: ExenatidePre-dosed inject-able pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months |
| Placebo | Placebo comparator | Drug: PlaceboPre-dosed inject-able pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExenatideAlso: ByettaSubcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID) | Drug | Exenatide |
| PlaceboSubcutaneous injection 2.5 mcg-10 mcg BID | Drug | Placebo |
Primary outcome
Peak Oxygen Consumption (VO2 Peak)
Time frame: Baseline and 3 months
Subjects' peak oxygen consumption (VO2 peak) will be tested on a stationary bike before and after 3 months of study medication or placebo.
14 secondary outcomes
Oxygen Uptake Kinetics Steady State Tau
Time frame: Baseline and 3 months
Change From Baseline in Arterial Stiffness
Time frame: Baseline and 3 months
Change From Baseline in Peak Dilation of Brachial Artery Diameter
Time frame: Baseline and 3 months
Change in (Non-invasively Measured) Deoxygenated Hemoglobin Concentration in the Vastus Lateralis During Exercise
Time frame: Baseline and 3 months
Echocardiographic Measures - Circumferential Strain
Time frame: Baseline and 3 months
Echocardiographic Measures - Longitudinal Strain
Time frame: Baseline and 3 months
Echocardiographic Measures - Stroke Volume
Time frame: Baseline and 3 months
Echocardiographic Measures - Mitral Valve E Wave Velocity
Time frame: Baseline and 3 months
Echocardiographic Measures - Mitral Valve E:A Wave Velocity
Time frame: Baseline and 3 months
Echocardiographic Measures - Mitral Valve Deceleration Time
Time frame: Baseline and 3 months
Echocardiographic Measures - Septal E'
Time frame: Baseline and 3 months
Echocardiographic Measures - Septal E:E'
Time frame: Baseline and 3 months
Echocardiographic Measures - Lateral E'
Time frame: Baseline and 3 months
Echocardiographic Measures - Lateral E:E'
Time frame: Baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith G Regensteiner, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exenatide in people with Type 2 Diabetes, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Oxygen Consumption (VO2 Peak) (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.