Type 2 DiabetesNCT01993121
Exercise and Type 2 Diabetes: Gender and Endothelial Function
A study testing Supervised Exercise Training in people with Type 2 Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The objective of the current proposal is to evaluate the importance of blood vessel dysfunction and heart dysfunction to overall exercise impairments in type 2 diabetes and their contribution to the gender differences observed in exercise capacity. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Supervised Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Sep 2008
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women between the ages of 30 and 55 years
- Persons with type 2 diabetes taking only certain oral medications (
- Pre-menopausal women
- Persons with type 2 diabetes who have a total HbA1c level <9%
- Persons with a BMI between 25-35.
Who cannot join
- Current smokers or anyone who has smoked within the last year
- Persons who have clinically evident distal symmetrical neuropathy
- Abnormal lipid levels (total cholesterol >200, LDL-cholesterol level >130, or triglyceride level >250).
- Persons with regional wall motion abnormalities, left ventricular wall thickness >1.1 cm , or decreased contractility.
- Persons will also be excluded if they have evidence of ischemic heart disease by history or abnormal resting or exercise electrocardiogram (ECG).
- Presence of systolic blood pressure >140 mmHg at rest or >250 mmHg with exercise or diastolic pressure >90 mmHg at rest or >105 mmHg with exercise will be grounds for exclusion.
Show all 10Show fewer
- Subjects will be excluded who have peripheral arterial disease.
- Persons with autonomic insufficiency, assessed by measuring variation in RR intervals with cycled breathing and by presence of a >20 mm fall in upright blood pressure without a change in heart rate, will be excluded.
- Subjects with proteinuria (urine protein >200 mg/dl) or a creatinine > 2 mg/dl, suggestive of renal disease will be excluded.
- Controls will not be accepted with an immediate family history of Type 2 Diabetes Mellitis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
The objective of the current proposal is to evaluate the importance of blood vessel dysfunction and heart dysfunction to overall exercise impairments in type 2 diabetes and their contribution to the gender differences observed in exercise capacity. Importantly, treatments that improve blood vessel function in persons with type 2 diabetes can be used to directly assess whether impairment in blood vessel function and ultimately exercise performance, can be improved and whether the degree of improvement differs between the sexes.
Hypothesis 1. Uncomplicated type 2 diabetes more adversely affects exercise capacity in women than men.
Read more
Hypothesis 2. Blood vessel function and cardiac function are more significantly impaired in women with type 2 diabetes than men and contribute to the gender differences in exercise capacity.
Hypothesis 3. Restoration of blood vessel function will improve exercise capacity more in women than men with type 2 diabetes.
Read the detailed description
Subjects will come in for a total of seven research visits. Four initial study visits before exercise training for three months and then subjects will repeat the testing.
- Initial exam. A history and physical exam will be performed. Blood will be drawn for measurements of overall health. Resting electrocardiogram will be obtained. The Low Level Physical Activity Recall (LOPAR) questionnaire will be administered.
- Dual Energy X-ray Absorptiometry (DEXA) will be carried out during visit two. A familiarization bicycle ergometer test will also be performed on this day.
- During visit three, a euglycemic clamp will be performed.
- During visit four, echocardiographic measurements will be made and a diet interview will be performed.
- On visit five, measures of blood vessel-dependent vasodilation will be performed. Repeated brachial artery diameter and forearm blood flow responses to cuff occlusion will be measured separately on this occasion.
- On visit six, arterial stiffness will be measured. Subjects will also perform a graded bicycle exercise test.
- On visit seven, subjects will perform constant level bicycle tests.
- Conditions
- Type 2 Diabetes
- Being tested
- Supervised Exercise Training
- Keywords
- diabetes, exercise, heart, cardiovascular
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Exercise TrainingOther
All subjects will perform three months of supervised exercise training.
| Study group | Role | What they receive |
|---|---|---|
| Three-month exercise training program | Experimental | All subjects will perform three months of supervised exercise training. Receives: Other: Supervised Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in cardiovascular exercise performance
Subjects' peak oxygen consumption will be tested on a stationary bike before and after 3 months of exercise training.
Measured: baseline and 3 months
Changes from baseline in cardiovascular exercise performance
Subjects' oxygen uptake kinetics will be tested on a stationary bike before and after 3 months of exercise training.
Measured: baseline and 3 months
Changes from baseline in cardiovascular exercise performance
Subjects' tissue oxygen saturation will be tested during exercise testing before and after 3 months of exercise training.
Measured: baseline and 3 months
Secondary outcomes (3)
Changes from baseline in endothelial function will be measured
Endothelial-dependent vasodilation will be determined in the peripheral circulation by measurement of changes in brachial artery diameter in response to cuff occlusion.
Measured: baseline and 3 months
Changes from baseline in endothelial function will be measured
Forearm blood flow will be assessed by plethysmography before and after cuff occlusion.
Measured: baseline and 3 months
Changes from baseline in diastolic function will be measured
The role of diastolic function in the exercise impairments will be examined using advanced echocardiographic techniques during rest and exercise
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 posted25 Nov 2013 (estimated)
- Study startSep 2002
- Primary completionSep 2008
- Study completionSep 2008
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 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Judith G Regensteiner, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993121
- Sponsor's protocol ID
- 02-0514
- Status last verified
- Nov 2013
- First submitted
- 12 Nov 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Type 2 Diabetes: Gender and Endothelial Function
- ClinicalTrials.gov ID
- NCT01993121
- Acronym / sponsor ID
- 02-0514
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes, exercise, heart, cardiovascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Sep 2002
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 25 Nov 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 objective of the current proposal is to evaluate the importance of blood vessel dysfunction and heart dysfunction to overall exercise impairments in type 2 diabetes and their contribution to the gender differences observed in exercise capacity. Importantly, treatments that improve blood vessel function in persons with type 2 diabetes can be used to directly assess whether impairment in blood vessel function and ultimately exercise performance, can be improved and whether the degree of improvement differs between the sexes.
Hypothesis 1. Uncomplicated type 2 diabetes more adversely affects exercise capacity in women than men.
Hypothesis 2. Blood vessel function and cardiac function are more significantly impaired in women with type 2 diabetes than men and contribute to the gender differences in exercise capacity.
Hypothesis 3. Restoration of blood vessel function will improve exercise capacity more in women than men with type 2 diabetes.
Detailed description
Subjects will come in for a total of seven research visits. Four initial study visits before exercise training for three months and then subjects will repeat the testing.
- Initial exam. A history and physical exam will be performed. Blood will be drawn for measurements of overall health. Resting electrocardiogram will be obtained. The Low Level Physical Activity Recall (LOPAR) questionnaire will be administered.
- Dual Energy X-ray Absorptiometry (DEXA) will be carried out during visit two. A familiarization bicycle ergometer test will also be performed on this day.
- During visit three, a euglycemic clamp will be performed.
- During visit four, echocardiographic measurements will be made and a diet interview will be performed.
- On visit five, measures of blood vessel-dependent vasodilation will be performed. Repeated brachial artery diameter and forearm blood flow responses to cuff occlusion will be measured separately on this occasion.
- On visit six, arterial stiffness will be measured. Subjects will also perform a graded bicycle exercise test.
- On visit seven, subjects will perform constant level bicycle tests.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Three-month exercise training program | Experimental | Other: Supervised Exercise TrainingAll subjects will perform three months of supervised exercise training. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and women between the ages of 30 and 55 years
- Persons with type 2 diabetes taking only certain oral medications (
- Pre-menopausal women
- Persons with type 2 diabetes who have a total HbA1c level <9%
- Persons with a BMI between 25-35.
Key exclusion criteria (10 listed)
- Current smokers or anyone who has smoked within the last year
- Persons who have clinically evident distal symmetrical neuropathy
- Abnormal lipid levels (total cholesterol >200, LDL-cholesterol level >130, or triglyceride level >250).
- Persons with regional wall motion abnormalities, left ventricular wall thickness >1.1 cm , or decreased contractility.
- Persons will also be excluded if they have evidence of ischemic heart disease by history or abnormal resting or exercise electrocardiogram (ECG).
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 |
|---|---|---|
| Supervised Exercise TrainingAll subjects will perform three months of supervised exercise training. | Other | Three-month exercise training program |
Primary outcome
Changes from baseline in cardiovascular exercise performance
Time frame: baseline and 3 months
Subjects' peak oxygen consumption will be tested on a stationary bike before and after 3 months of exercise training.
Changes from baseline in cardiovascular exercise performance
Time frame: baseline and 3 months
Subjects' oxygen uptake kinetics will be tested on a stationary bike before and after 3 months of exercise training.
Changes from baseline in cardiovascular exercise performance
Time frame: baseline and 3 months
Subjects' tissue oxygen saturation will be tested during exercise testing before and after 3 months of exercise training.
3 secondary outcomes
Changes from baseline in endothelial function will be measured
Time frame: baseline and 3 months
Changes from baseline in endothelial function will be measured
Time frame: baseline and 3 months
Changes from baseline in diastolic function will be measured
Time frame: baseline and 3 months
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 25 Nov 2013.
Related trials for Type 2 Diabetes
Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Enrolling by invitation
MTM2MTG Pilot Ancillary Study
Diet, Healthy, HbA1c
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
Not yet recruitingPhase 1/2
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Cochlear Synaptopathy
Not yet recruitingPhase 1
A Research Study to Check the Safety of NNC9836-0001 When Given to Healthy Participants and Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2
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 Supervised Exercise Training 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 5 inclusion and 10 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 25 Nov 2013. 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?
Changes from baseline in cardiovascular exercise performance (time frame: baseline and 3 months). The study lists 3 primary outcomes in all. 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 25 Nov 2013.