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Exercise and Type 2 Diabetes: Gender and Endothelial Function

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ClinicalTrials.gov Identifier: NCT01993121
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
University of Colorado, Denver

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Other: Supervised Exercise Training Not Applicable

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.

  1. 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.
  2. 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.
  3. During visit three, a euglycemic clamp will be performed.
  4. During visit four, echocardiographic measurements will be made and a diet interview will be performed.
  5. 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.
  6. On visit six, arterial stiffness will be measured. Subjects will also perform a graded bicycle exercise test.
  7. On visit seven, subjects will perform constant level bicycle tests.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Exercise and Type 2 Diabetes: Gender and Endothelial Function
Study Start Date : September 2002
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Three-month exercise training program
All subjects will perform three months of supervised exercise training.
Other: Supervised Exercise Training
All subjects will perform three months of supervised exercise training.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Changes from baseline in endothelial function will be measured [ Time Frame: baseline and 3 months ]
    Endothelial-dependent vasodilation will be determined in the peripheral circulation by measurement of changes in brachial artery diameter in response to cuff occlusion.

  2. Changes from baseline in endothelial function will be measured [ Time Frame: baseline and 3 months ]
    Forearm blood flow will be assessed by plethysmography before and after cuff occlusion.

  3. Changes from baseline in diastolic function will be measured [ Time Frame: baseline and 3 months ]
    The role of diastolic function in the exercise impairments will be examined using advanced echocardiographic techniques during rest and exercise



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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993121


Locations
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United States, Colorado
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
American Diabetes Association
Investigators
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Principal Investigator: Judith G Regensteiner, PhD University of Colorado, Denver
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01993121    
Other Study ID Numbers: 02-0514
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Keywords provided by University of Colorado, Denver:
diabetes
exercise
heart
cardiovascular
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases