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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

Tracking Information
First Submitted Date  ICMJE November 12, 2013
First Posted Date  ICMJE November 25, 2013
Last Update Posted Date November 25, 2013
Study Start Date  ICMJE September 2002
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise and Type 2 Diabetes: Gender and Endothelial Function
Official Title  ICMJE Exercise and Type 2 Diabetes: Gender and Endothelial Function
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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE Other: Supervised Exercise Training
All subjects will perform three months of supervised exercise training.
Study Arms  ICMJE Experimental: Three-month exercise training program
All subjects will perform three months of supervised exercise training.
Intervention: Other: Supervised Exercise Training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2013)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01993121
Other Study ID Numbers  ICMJE 02-0514
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE American Diabetes Association
Investigators  ICMJE
Principal Investigator: Judith G Regensteiner, PhD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP