Skip to main content
OpenTrials
Completed

NCT Number: NCT00387452

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vancouver General Hospital Research Pavilion

Vancouver, British Columbia, V5Z 1L8, Canada

About this study

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise and Strength Exercise

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Pulse wave velocity (central and peripheral)

  2. Drop in middle cerebral artery velocity with upright tilting

  3. Drop in blood pressure with upright tilt

  4. Arterial baroreflex sensitivity

  5. Time and frequency domain measures of heart rate variability

Secondary outcomes

  1. Fasting blood glucose, HgbA1C

  2. VO2max

  3. Dynamometry measures of muscle strength

  4. Resting and maximal heart rate

  5. Waist to hip ratio, BMI

  6. Lean body mass/% fat

  7. Catecholamines

  8. Increase in Gosling's pulsatility index

  9. Linear transfer-function analysis of cerebral autoregulation during upright tilt

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Oct 13, 2006
Registry last updated
Apr 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.