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

Primary Purpose

Cardiovascular, Diabetic

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Aerobic Exercise and Strength Exercise

Strength training

About this trial

This is an interventional other trial for Cardiovascular focused on measuring 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

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Vancouver General Hospital Research Pavilion

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

Arm Description

No intervention, only testing during 6 months.

Outcomes

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

Full Information

NCT ID

NCT00387452

First Posted

October 11, 2006

Last Updated

April 12, 2017

Sponsor

University of British Columbia

Collaborators

Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT00387452

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

February 2006 (Actual)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

Collaborators

Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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).

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiovascular, Diabetic

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

No Intervention

Arm Description

No intervention, only testing during 6 months.

Intervention Type

Behavioral

Intervention Name(s)

Aerobic Exercise and Strength Exercise

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Strength training

Intervention Description

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 Outcome Measure Information:

Title

Pulse wave velocity (central and peripheral)

Title

Drop in middle cerebral artery velocity with upright tilting

Title

Drop in blood pressure with upright tilt

Title

Arterial baroreflex sensitivity

Title

Time and frequency domain measures of heart rate variability

Secondary Outcome Measure Information:

Title

Fasting blood glucose, HgbA1C

Title

VO2max

Title

Dynamometry measures of muscle strength

Title

Resting and maximal heart rate

Title

Waist to hip ratio, BMI

Title

Lean body mass/% fat

Title

Catecholamines

Title

Increase in Gosling's pulsatility index

Title

Linear transfer-function analysis of cerebral autoregulation during upright tilt

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kenneth Madden, MD

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vancouver General Hospital Research Pavilion

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1L8

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

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

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