Type 2 DiabetesNCT01883258
Effect of Aerobic Interval Training on Cardiovascular Function in Type 2 Diabetes
A study testing High intensity aerobic interval training and Continuous moderate intensity exercise in people with Type 2 Diabetes, run by University of Florida at 1 site in United States.
Trial summary
The study objectives are: 1. To compare cardiovascular function in type 2 diabetes patients vs. healthy controls. 2. To compare the effect of 8 weeks of aerobic interval training versus continuous moderate exercise on cardiovascular function in adults with type 2 diabetes. 3. Read more about this study
- Who is it for?
- Ages 30 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- High intensity aerobic interval training and Continuous moderate intensity exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to 16 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetes
- Sedentary or minimally physically active for at least the prior 1 year
- Able to give consent
- Sedentary or minimally physically active for at least the prior 1 year
- Able to give consent
Who cannot join
- History of diabetic proliferative retinopathy, autonomic or peripheral neuropathy
- History of any relevant cardiovascular diseases (myocardial infarction, angina pectoris, history of coronary artery bypass surgery or angioplasty, congestive heart failure, or arrhythmia)
- Hypertension (≥160 mmHg systolic or ≥100 mmHg diastolic)
- History of renal impairment
- History of gout or hyperuricemia
- History of hepatic disease or infection with hepatitis B, C
Show all 14Show fewer
- History of seizures, or other relevant on-going or recurrent illness
- Recent (within 3 months) or recurrent hospitalizations
- Use of tobacco products
- >5 % weight change in the prior 6 months.
- Current intake of medications that may affect study results
- Premenopausal women taking oral contraceptives and postmenopausal women taking hormone replacement therapy.
- Pregnancy (positive urine pregnancy test) or lactation
- For the healthy control group, history of diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanisms of Cardiovascular Dysfunction and Effect of Aerobic Exercise Training in Adults With Type 2 Diabetes
The study objectives are:
- To compare cardiovascular function in type 2 diabetes patients vs. healthy controls.
- To compare the effect of 8 weeks of aerobic interval training versus continuous moderate exercise on cardiovascular function in adults with type 2 diabetes.
- To examine the mechanisms underlying the exercise-related changes in cardiovascular function.
The investigators hypothesize that compared to continuous moderate intensity exercise training, interval training will be more effective in improving cardiovascular function in adults with type 2 diabetes.
Read the detailed description
Cardiovascular function will be measured at baseline in adults with type 2 diabetes and in age-matched healthy controls. Research volunteers with type 2 diabetes who meet the inclusion criteria will be randomized to the aerobic interval training group, continuous moderate exercise group or non-exercise control group. At the end of the 8-week randomized control exercise intervention, baseline measures will be repeated.
- Conditions
- Type 2 Diabetes
- Being tested
- High intensity aerobic interval training, Continuous moderate intensity exercise
- 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.
High intensity aerobic interval trainingOther
Supervised aerobic interval training will be performed on bicycles 4 times per week for 8 weeks. Each training session will last 40 minutes and will consist of 10-minute warm up at 70% of maximal heart rate (HRmax), four 4-minute intervals at 90% of HRmax with 3-min active recovery at 70% of HRmax and 5-minute cool down at 70% of HRmax.
Continuous moderate intensity exerciseOther
Supervised exercise training will be performed on bicycles 4 times per week for 8 weeks. Each training session will last 47 minutes and will consist of continuous moderate intensity cycling at 70% of HRmax.
| Study group | Role | What they receive |
|---|---|---|
| High intensity aerobic interval training | Experimental | Type 2 diabetes subjects will complete 8 weeks of high intensity aerobic interval exercise training. Receives: Other: High intensity aerobic interval training |
| Continuous moderate intensity exercise | Experimental | Type 2 diabetes subjects will complete 8 weeks of continuous moderate intensity exercise training. Receives: Other: Continuous moderate intensity exercise |
| Non-exercise control group | No intervention | Type 2 diabetes subjects assigned to the non-exercise control group will maintain their normal lifestyle for 8 weeks. |
| Healthy control group | No intervention | Healthy subjects will be assigned to the healthy control group and will undergo baseline measures only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vascular endothelial function
Brachial flow mediated dilation using ultrasonography
Measured: At baseline and after 8 weeks of exercise training
Secondary outcomes (4)
Change in factors related with endothelial function
Blood and cellular markers of adiponectin, oxidative stress and inflammation.
Measured: At baseline and after 8 weeks of exercise training
Change in arterial stiffness
Arterial stiffness (pulse wave velocity) and wave reflection (augmentation index) will be measured using the SphygmoCor device.
Measured: At baseline and after 8 weeks of exercise training
Change in cardiac function
Left ventricular systolic and diastolic function will be measured using echocardiography.
Measured: At baseline and after 8 weeks of exercise training
Change in maximal oxygen consumption
Maximal oxygen consumption will be measured using online computer-assisted open-circuit spirometry during incremental treadmill exercise.
Measured: At baseline and after 8 weeks of exercise training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startMay 2013
- Primary completion16 Jul 2018
- Study completion16 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Demetra D Christou, Ph.D, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883258
- Sponsor's protocol ID
- IRB201601534-N
- Other IDs
- 280-2012, 1R21AG050203-01, OCR12584
- Status last verified
- Dec 2019
- First submitted
- 13 Jun 2013
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Cardiovascular Dysfunction and Effect of Aerobic Exercise Training in Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01883258
- Acronym / sponsor ID
- IRB201601534-N
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- May 2013 (actual)
- Primary completion
- 16 Jul 2018 (actual)
- Study completion
- 16 Jul 2018 (actual)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objectives are:
- To compare cardiovascular function in type 2 diabetes patients vs. healthy controls.
- To compare the effect of 8 weeks of aerobic interval training versus continuous moderate exercise on cardiovascular function in adults with type 2 diabetes.
- To examine the mechanisms underlying the exercise-related changes in cardiovascular function.
The investigators hypothesize that compared to continuous moderate intensity exercise training, interval training will be more effective in improving cardiovascular function in adults with type 2 diabetes.
Detailed description
Cardiovascular function will be measured at baseline in adults with type 2 diabetes and in age-matched healthy controls. Research volunteers with type 2 diabetes who meet the inclusion criteria will be randomized to the aerobic interval training group, continuous moderate exercise group or non-exercise control group. At the end of the 8-week randomized control exercise intervention, baseline measures will be repeated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High intensity aerobic interval training | Experimental | Other: High intensity aerobic interval trainingType 2 diabetes subjects will complete 8 weeks of high intensity aerobic interval exercise training. |
| Continuous moderate intensity exercise | Experimental | Other: Continuous moderate intensity exerciseType 2 diabetes subjects will complete 8 weeks of continuous moderate intensity exercise training. |
| Non-exercise control group | No intervention | –Type 2 diabetes subjects assigned to the non-exercise control group will maintain their normal lifestyle for 8 weeks. |
| Healthy control group | No intervention | –Healthy subjects will be assigned to the healthy control group and will undergo baseline measures only. |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of type 2 diabetes
- Sedentary or minimally physically active for at least the prior 1 year
- Able to give consent
- Sedentary or minimally physically active for at least the prior 1 year
- Able to give consent
Key exclusion criteria (14 listed)
- History of diabetic proliferative retinopathy, autonomic or peripheral neuropathy
- History of any relevant cardiovascular diseases (myocardial infarction, angina pectoris, history of coronary artery bypass surgery or angioplasty, congestive heart failure, or arrhythmia)
- Hypertension (≥160 mmHg systolic or ≥100 mmHg diastolic)
- History of renal impairment
- History of gout or hyperuricemia
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 |
|---|---|---|
| High intensity aerobic interval trainingSupervised aerobic interval training will be performed on bicycles 4 times per week for 8 weeks. Each training session will last 40 minutes and will consist of 10-minute warm up at 70% of maximal heart rate (HRmax), four 4-minute intervals at 90% of HRmax with 3-min active recovery at 70% of HRmax and 5-minute cool down at 70% of HRmax. | Other | High intensity aerobic interval training |
| Continuous moderate intensity exerciseSupervised exercise training will be performed on bicycles 4 times per week for 8 weeks. Each training session will last 47 minutes and will consist of continuous moderate intensity cycling at 70% of HRmax. | Other | Continuous moderate intensity exercise |
Primary outcome
Change in vascular endothelial function
Time frame: At baseline and after 8 weeks of exercise training
Brachial flow mediated dilation using ultrasonography
4 secondary outcomes
Change in factors related with endothelial function
Time frame: At baseline and after 8 weeks of exercise training
Change in arterial stiffness
Time frame: At baseline and after 8 weeks of exercise training
Change in cardiac function
Time frame: At baseline and after 8 weeks of exercise training
Change in maximal oxygen consumption
Time frame: At baseline and after 8 weeks of exercise training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
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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.
Demetra D Christou, Ph.D principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity aerobic interval training and Continuous moderate intensity exercise in people with Type 2 Diabetes, run by University of Florida 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 5 inclusion and 14 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 6 Dec 2019. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in vascular endothelial function (time frame: At baseline and after 8 weeks of exercise training). 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 6 Dec 2019.