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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00387452
Other study ID # H04-70001
Secondary ID ORSIL# 05-0820
Status Completed
Phase N/A
First received October 11, 2006
Last updated April 12, 2017
Start date February 2006
Est. completion date April 2012

Study information

Verified date April 2017
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Canada Vancouver General Hospital Research Pavilion Vancouver British Columbia

Sponsors (2)

Lead Sponsor Collaborator
University of British Columbia Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pulse wave velocity (central and peripheral) Unspecified
Primary Drop in middle cerebral artery velocity with upright tilting Unspecified
Primary Drop in blood pressure with upright tilt Unspecified
Primary Arterial baroreflex sensitivity Unspecified
Primary Time and frequency domain measures of heart rate variability Unspecified
Secondary Fasting blood glucose, HgbA1C Unspecified
Secondary VO2max Unspecified
Secondary Dynamometry measures of muscle strength Unspecified
Secondary Resting and maximal heart rate Unspecified
Secondary Waist to hip ratio, BMI Unspecified
Secondary Lean body mass/% fat Unspecified
Secondary Catecholamines Unspecified
Secondary Increase in Gosling's pulsatility index Unspecified
Secondary Linear transfer-function analysis of cerebral autoregulation during upright tilt Unspecified
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