Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00195884
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2005-09-12
Brief Title:
Diabetes Aerobic and Resistance Exercise DARE Study
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
Resistance Exercise as an Intervention in Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this study is to assess the impact of exercise training aerobic exercise resistance exercise combined aerobic and resistance exercise versus a sedentary waiting list control on glycemic control as reflected in reduced hemoglobin A1c HbA1c body composition weight body mass index BMI waist circumference total body fat visceral and subcutaneous abdominal fat mid-thigh muscle cross-sectional area lipids Apo-B Apo-A1 Apo-BA1 ratio low density lipoprotein LDL particle diameter high-sensitivity C-reactive protein and quality of life
Detailed Description:
Background The incidence of type 2 diabetes mellitus in the Western world is rising rapidly due to increases in obesity and sedentary behaviour and diabetes is among the most potent common risk factors for premature disability and mortality Landmark clinical trials such as the UK Prospective Diabetes Study proved that these excess risks in type 2 diabetes can be reduced through relatively modest improvements in glycemic control HbA1c difference of 09 over time The excess morbidity and mortality in diabetes is attributable both to hyperglycemia and to a cluster of other metabolic disturbances associated with insulin resistance and exercise can have beneficial effects on all of these abnormalities The standard recommendation to people with diabetes has been to perform aerobic exercise such as brisk walking swimming or jogging There is very little research on resistance exercise such as weight lifting or exercise with weight machines in type 2 diabetes Resistance exercise in non-diabetic subjects increases lean body mass resulting in increased metabolic rate decreased insulin resistance and increased glucose disposal Furthermore in a recent randomized trial the addition of resistance exercise to a cardiac rehabilitation program resulted in marked improvements in quality of life to a far greater extent than seen with aerobic exercise alone For these reasons we feel that resistance exercise in type 2 diabetes is a modality worthy of further research A pilot study of our present proposal funded by the Canadian Diabetes Association CDA is in progress compliance has been excellent with 90 attendance
Primary research question In patients with type 2 diabetes does a 6-month resistance or aerobic training program result in improved glycemic control as reflected in reduced hemoglobin A1c HbA1c Is the effect of one type of exercise additive to that of the other
Secondary research questions In patients with type 2 diabetes what are the effects of each exercise modality on
1 Body composition assessed using gold-standard methods including CT scan and deuterium oxide resting energy expenditure using indirect calorimetry and insulin resistance To what extent do changes in these parameters mediate changes in HbA1c
2 Important nontraditional metabolic CHD risk factors LDL particle diameter plasma insulin apoprotein B c-reactive protein free fatty acids and traditional metabolic CHD risk factors HDL-C LDL-C triglycerides totalHDL cholesterol ratio BP
3 Health-related quality of life QOL as measured by the Well-Being questionnaire or the SF-36 Does modality of exercise or change in quality of life from baseline to 6 months predict frequency of exercise during the 6 months following the intervention
Study design Randomized controlled trial After a 4-week supervised low-intensity exercise run-in period to test compliance previously inactive Type 2 diabetic subjects not currently engaging in regular exercise are randomized to 4 arms aerobic exercise 3X per week resistance exercise 3X per week both combined or waiting-list control The exercise intervention takes place at YMCA branches in metropolitan Ottawa Exercise is closely supervised and progressive in intensity and duration Compliance is verified through direct supervision completion of detailed exercise logs and central automated electronic tracking of YMCA attendance through scanning of membership cards Primary outcomes are measured at 6 months At the end of 6 months subjects are given a maintenance program and reexamined 6 months later to assess the durability of any benefits from the exercise program During the 6 month intervention period diet is standardized using repeated sessions with a dietitian and doses of medications altering glucose lipids and BP are held constant unless change is medically urgent
Significance The global burden of type 2 diabetes is increasing and complications of the illness occur primarily in those whose glycemic control is fair or poor If appropriately selected exercise training improves glycemic control and is adopted by more patients it is likely that the morbidity associated with type 2 diabetes will be decreased This is particularly true if such training also improves quality of life and more people are thus inclined to continue exercising in the long term
Primary research question In patients with type 2 diabetes does a 6-month resistance or aerobic training program result in improved glycemic control as reflected in reduced hemoglobin A1c HbA1c Is the effect of one type of exercise additive to that of the other
Secondary research questions In patients with type 2 diabetes what are the effects of each exercise modality on
1 Body composition assessed using gold-standard methods including CT scan and deuterium oxide resting energy expenditure using indirect calorimetry and insulin resistance To what extent do changes in these parameters mediate changes in HbA1c
2 Important nontraditional metabolic CHD risk factors LDL particle diameter plasma insulin apoprotein B c-reactive protein free fatty acids and traditional metabolic CHD risk factors HDL-C LDL-C triglycerides totalHDL cholesterol ratio BP
3 Health-related quality of life QOL as measured by the Well-Being questionnaire or the SF-36 Does modality of exercise or change in quality of life from baseline to 6 months predict frequency of exercise during the 6 months following the intervention
Study design Randomized controlled trial After a 4-week supervised low-intensity exercise run-in period to test compliance previously inactive Type 2 diabetic subjects not currently engaging in regular exercise are randomized to 4 arms aerobic exercise 3X per week resistance exercise 3X per week both combined or waiting-list control The exercise intervention takes place at YMCA branches in metropolitan Ottawa Exercise is closely supervised and progressive in intensity and duration Compliance is verified through direct supervision completion of detailed exercise logs and central automated electronic tracking of YMCA attendance through scanning of membership cards Primary outcomes are measured at 6 months At the end of 6 months subjects are given a maintenance program and reexamined 6 months later to assess the durability of any benefits from the exercise program During the 6 month intervention period diet is standardized using repeated sessions with a dietitian and doses of medications altering glucose lipids and BP are held constant unless change is medically urgent
Significance The global burden of type 2 diabetes is increasing and complications of the illness occur primarily in those whose glycemic control is fair or poor If appropriately selected exercise training improves glycemic control and is adopted by more patients it is likely that the morbidity associated with type 2 diabetes will be decreased This is particularly true if such training also improves quality of life and more people are thus inclined to continue exercising in the long term
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None