Diabetes Clinical Trial
Official title:
The Use of a Home-based Walking Program to Treat Orthostatic Hypotension in Older Adults With Type 2 Diabetes
Verified date | April 2017 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 a home-based walking program.
Status | Completed |
Enrollment | 13 |
Est. completion date | September 2015 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
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 (as defined by no strength training and less than 30 minutes brisk walking/moderate exercise per week and no vigorous exercise in the preceding 6 months) - All subjects will have a fasting glucose of <12 mM and a hemoglobin A1c < 8.5% - Orthostatic hypotension defined as a decrease in systolic blood pressure of at least 20 mm Hg or diastolic blood pressure of at least 10 mm Hg within 3 minutes of assuming an upright posture on the initial screening visit as per current American Academy of Neurology guidelines. 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) - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Dr. Scott Lear's Lab, Simon Fraser University, Harbour | Vancouver | British Columbia |
Canada | VITALiTY Research Centre - VGH Research Pavilion | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pulse wave velocity (central and peripheral) | Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase | ||
Primary | Drop in middle cerebral artery velocity with upright tilting | Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase | ||
Primary | Drop in blood pressure with upright tilt | Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase | ||
Primary | Arterial baroreflex sensitivity | Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase | ||
Secondary | Fasting blood glucose, HgbA1C | Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase. | ||
Secondary | VO2max | Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase. | ||
Secondary | Dynamometry measures of muscle strength | Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase. | ||
Secondary | Resting and maximal heart rate | Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase. | ||
Secondary | Waist to hip ratio, BMI | Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase. | ||
Secondary | Lean body mass/% fat | Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase. | ||
Secondary | Catecholamines | Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase. | ||
Secondary | Increase in Gosling's pulsatility index | Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05594446 -
Morphometric Study of the Legs and Feet of Diabetic Patients in Order to Collect Data Intended to be Used to Measure by Dynamometry the Pressures Exerted by Several Medical Compression Socks at the Level of the Forefoot
|
||
Completed |
NCT03975309 -
DHS MIND Metabolomics
|
||
Completed |
NCT01855399 -
Technologically Enhanced Coaching: A Program to Improve Diabetes Outcomes
|
N/A | |
Completed |
NCT01819129 -
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
|
Phase 3 | |
Recruiting |
NCT04984226 -
Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD
|
Phase 2 | |
Recruiting |
NCT05007990 -
Caregiving Networks Across Disease Context and the Life Course
|
||
Active, not recruiting |
NCT04420936 -
Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program
|
N/A | |
Recruiting |
NCT03549559 -
Imaging Histone Deacetylase in the Heart
|
N/A | |
Completed |
NCT04903496 -
Clinical Characteristics and Disease Burden of Diabetic Patients Based on Tianjin Regional Database
|
||
Completed |
NCT01437592 -
Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects
|
Phase 1 | |
Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Completed |
NCT03390179 -
Hyperglycemic Response and Steroid Administration After Surgery (DexGlySurgery)
|
||
Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
|
N/A | |
Recruiting |
NCT05294822 -
Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes
|
N/A | |
Completed |
NCT04427982 -
Dance and Diabetes/Prediabetes Self-Management
|
N/A | |
Completed |
NCT02356848 -
STEP UP to Avert Amputation in Diabetes
|
N/A | |
Completed |
NCT03292185 -
A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects
|
Phase 1 | |
Active, not recruiting |
NCT05477368 -
Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes
|
N/A | |
Completed |
NCT04496401 -
PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus
|
Phase 4 |