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Exercise and Cardiovascular Control During Upright Tilt in Older Adults With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00387452
First Posted: October 13, 2006
Last Update Posted: April 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Kenneth Madden, University of British Columbia
  Purpose
Older persons with diabetes have a harder time maintaining blood pressure when standing up. When blood pressure drops when standing up, fainting may occur. This study will see how regular exercise can improve the ability of the body to keep blood pressure up when standing. We want to see how this improvement varies with different types of exercise. The types of exercise that we will be studying are aerobic (running or cycling on a stationary bike) and strength training (weight lifting).

Condition Intervention
Cardiovascular Diabetic Behavioral: Aerobic Exercise and Strength Exercise Behavioral: Strength training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Exercise and Cardiovascular Control During Upright Tilt in Older Adults With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Kenneth Madden, University of British Columbia:

Primary Outcome Measures:
  • Pulse wave velocity (central and peripheral)
  • Drop in middle cerebral artery velocity with upright tilting
  • Drop in blood pressure with upright tilt
  • Arterial baroreflex sensitivity
  • Time and frequency domain measures of heart rate variability

Secondary Outcome Measures:
  • Fasting blood glucose, HgbA1C
  • VO2max
  • Dynamometry measures of muscle strength
  • Resting and maximal heart rate
  • Waist to hip ratio, BMI
  • Lean body mass/% fat
  • Catecholamines
  • Increase in Gosling's pulsatility index
  • Linear transfer-function analysis of cerebral autoregulation during upright tilt

Enrollment: 64
Actual Study Start Date: February 2006
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Behavioral: Aerobic Exercise and Strength Exercise
6 months of aerobic training exercise. regulated by heart rate; work up to 80% of maximal heart rate on treadmill or stationary bike; 3 hours a week, 90% attendance.
Active Comparator: 2 Behavioral: Strength training
6 months of strength training exercise using weight machines involving legs and arms: 12-15 repetitions of weights per exercise; 3 hours a week, 90% attendance.
No Intervention: 3
No intervention, only testing during 6 months.

Detailed Description:
  1. PURPOSE: Older adults with diabetes faint frequently, due to an impairment in the cardiovascular control mechanisms (arterial baroreceptor function, autonomic nervous system function and cerebral autoregulation) that prevent syncope. The purpose of this study is to examine the ability of different intensities of aerobic exercise to reverse these impairments.
  2. HYPOTHESES: a) Aerobic or strength training will improve the compensatory cardiovascular responses that prevent syncope in older adults with Type 2 diabetes. Aerobic training will:

    • increase arterial baroreflex sensitivity
    • increase heart rate variability (marker of autonomic nervous system function)
    • decrease cerebrovascular resistance
    • improve cerebral autoregulation during upright tilt. b) There will be relationship between the improvement in compensatory cardiovascular responses and aerobic or strength training.

      c) The majority of the benefits of aerobic or strength exercise on the above parameters will with which training, allowing for the design of more practicable training prescriptions than that used in a research setting.

  Eligibility

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Type 2 diabetes for at least 5 years treated with diet alone or oral agents Nonsmoker for at least 5 years Subjects must be sedentary BMI between 24 and 35 All subjects will have a fasting glucose of <12 mM and a hemoglobin A1c < 8.5% All subjects must have developed hypertension CDA guidelines (systolic greater than 130 or diastolic greater than 80)

Exclusion Criteria:

  • Abnormalities on complete blood count, electrolytes or creatinine, on resting ECG, treadmill exercise stress test Significant pulmonary, exercise-limiting orthopedic or neurological impairment Evidence of valvular disease, exercise-induced syncope, angina, arrhythmias or peripheral vascular disease Poor blood pressure control as defined as systolic blood pressure greater than or equal to 160 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg Total cholesterol/HDL cholesterol greater than or equal to 5.0 or LDL cholesterol greater than or equal to 4.21 mmol/L Peripheral neuropathy severe enough to cause discomfort (for safety reasons) Significant orthostatic hypotension defined as a drop in systolic blood pressure greater than 30 mmHg during one of five consecutive arterial blood pressure readings immediately after changing position from lying to standing for safety.

Overt diabetic nephropathy excluding subjects with a urine albumin to creatinine ratio of greater than 2.0 in men or 2.8 in women Diabetic retinopathy

  Contacts and Locations
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): NCT00387452


Locations
Canada, British Columbia
Vancouver General Hospital Research Pavilion
Vancouver, British Columbia, Canada, V5Z 1L8
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Kenneth Madden, MD University of British Columbia
  More Information

Responsible Party: Kenneth Madden, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT00387452     History of Changes
Other Study ID Numbers: H04-70001
ORSIL# 05-0820
First Submitted: October 11, 2006
First Posted: October 13, 2006
Last Update Posted: April 14, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kenneth Madden, University of British Columbia:
Aging
Type 2 diabetes
exercise
aerobic training
strength training
glucose metabolism arterial baroreceptors
heart rate variability
cerebral autoregulation
tilt table study
transcranial Doppler
autonomic nervous system

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases