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Exercise and Cardiovascular Control During Upright Tilt in Older Adults With Type 2 Diabetes
This study is currently recruiting participants.
Study NCT00387452.   Last updated on September 24, 2008.
Information provided by University of British Columbia
This Tabular View shows the required WHO registration data elements as marked by

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

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).

  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.

Interventional
Other, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Pulse wave velocity (central and peripheral) [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Drop in middle cerebral artery velocity with upright tilting [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Drop in blood pressure with upright tilt [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Arterial baroreflex sensitivity [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Time and frequency domain measures of heart rate variability [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Fasting blood glucose, HgbA1C [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
VO2max [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Dynamometry measures of muscle strength [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Resting and maximal heart rate [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Waist to hip ratio, BMI [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Lean body mass/% fat [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Catecholamines [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Increase in Gosling's pulsatility index [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Linear transfer-function analysis of cerebral autoregulation during upright tilt [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Cardiovascular
Diabetic
Behavioral: Aerobic Exercise and Strength Exercise
Behavioral: Strength training
 
Recruiting
60
February 2006
December 2010

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

Both
65 Years and older
Yes
Contact: Chris Lockhart 604-875-4111 ext 68535 lockhart@interchange.ubc.ca
Canada
 
NCT00387452
CO4-0001
ORSIL# 05-0820
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Kenneth Madden, Ph.D University of British Columbia
University of British Columbia
September 2008
October 11, 2006
September 24, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.