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

This study has been completed.
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Kenneth Madden, University of British Columbia Identifier:
First received: October 11, 2006
Last updated: April 12, 2017
Last verified: April 2017
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
Behavioral: Aerobic Exercise and Strength Exercise
Behavioral: Strength training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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) [ Time Frame: Unspecified ]
  • Drop in middle cerebral artery velocity with upright tilting [ Time Frame: Unspecified ]
  • Drop in blood pressure with upright tilt [ Time Frame: Unspecified ]
  • Arterial baroreflex sensitivity [ Time Frame: Unspecified ]
  • Time and frequency domain measures of heart rate variability [ Time Frame: Unspecified ]

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

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.


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

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

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Please refer to this study by its identifier: NCT00387452

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)
Principal Investigator: Kenneth Madden, MD University of British Columbia
  More Information

Responsible Party: Kenneth Madden, Principal Investigator, University of British Columbia Identifier: NCT00387452     History of Changes
Other Study ID Numbers: H04-70001
ORSIL# 05-0820
Study First Received: October 11, 2006
Last Updated: April 12, 2017
Individual Participant Data  
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:
Type 2 diabetes
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 processed this record on May 25, 2017