Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148538
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2005-09-06
Brief Title:
Type 1 Diabetes Aerobic and Resistance Exercise T1-DARE
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
Type 1 Diabetes Aerobic and Resistance Exercise T1-DARE
Status:
COMPLETED
Status Verified Date:
2019-07
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:
This is a randomized controlled trial evaluating different exercise modalities in previously inactive subjects with type 1 diabetes
The primary objective of this study is to determine the effects of resistance exercise training and of aerobic exercise training on glycemic control A1c in previously inactive individuals with type 1 diabetes with background therapy meeting modern standards including multiple daily insulin injections or insulin pump carbohydrate counting frequent glucose monitoring and utilization of glucose monitoring to adjust CHO and insulin for exercise
Secondary aims In type 1 diabetic individuals receiving therapy meeting the criteria above to determine the effects of resistance exercise training and aerobic exercise training on frequency of hypoglycemia body composition lipids C-reactive protein and quality of life
Hypotheses
1 Subjects randomized to resistance exercise R and AR combined will have greater reductions in A1c than in those not randomized to resistance exercise A and C combined
2 Subjects randomized to aerobic exercise A and AR combined will show a trend to greater HbA1c reduction than those not randomized to aerobic exercise R and C combined
Secondary hypotheses We expect that both aerobic and resistance exercise will show trends to improvement in most listed secondary outcomes
The primary objective of this study is to determine the effects of resistance exercise training and of aerobic exercise training on glycemic control A1c in previously inactive individuals with type 1 diabetes with background therapy meeting modern standards including multiple daily insulin injections or insulin pump carbohydrate counting frequent glucose monitoring and utilization of glucose monitoring to adjust CHO and insulin for exercise
Secondary aims In type 1 diabetic individuals receiving therapy meeting the criteria above to determine the effects of resistance exercise training and aerobic exercise training on frequency of hypoglycemia body composition lipids C-reactive protein and quality of life
Hypotheses
1 Subjects randomized to resistance exercise R and AR combined will have greater reductions in A1c than in those not randomized to resistance exercise A and C combined
2 Subjects randomized to aerobic exercise A and AR combined will show a trend to greater HbA1c reduction than those not randomized to aerobic exercise R and C combined
Secondary hypotheses We expect that both aerobic and resistance exercise will show trends to improvement in most listed secondary outcomes
Detailed Description:
Background Type 1 diabetes is characterized by complete or near-complete absence of insulin secretion generally due to autoimmune disease Cardiovascular disease CVD risk in type 1 diabetes is just as great as in type 2 diabetic individuals of the same age even though type 1 diabetic individuals usually have fewer additional CVD risk factors This is likely due to earlier age of onset of diabetes and therefore much longer exposure to hyperglycemia The incidence of type 1 diabetes is increasing throughout the world The reasons for this are thought to be environmental although the exact nature of the environmental precipitants is not well understood In contrast to type 2 diabetes in which it is clear that aerobic exercise improves glycemic control studies in type 1 diabetes have generally not found a significant beneficial effect for aerobic exercise on glycemic control even though there is often reduction in insulin requirements and improved insulin sensitivity This paradoxical finding may be because individuals with type 1 diabetes are at much higher risk of hypoglycaemia than type 2 and tend to increase their carbohydrate intake in an effort to avoid exercise-induced drops in glucose
The acute effects of resistance exercise on glycemia in type 1 diabetes have not been established it is possible that resistance exercise results in a smoother or more predictable decline in blood glucose than aerobic training does which might reduce fear of hypoglycemia and consequent overcompensation Resistance exercise training increases insulin receptor protein expression which is not true of aerobic exercise training
Study Design This will be a randomized controlled trial with a 2 by 2 factorial design resistance training versus no resistance training aerobic training versus no aerobic training in previously inactive subjects with type 1 diabetes After screening qualifying subjects will enter a 5-week stabilizationrun in period prior to randomization During this period their diet and insulin therapy will be assessed and optimized and in weeks 2-5 they will also undergo three supervised sessions of low-intensity exercise per week Those demonstrating adequate compliance during the run-in period will then be randomized in equal numbers to Aerobic Training A progressing to 45 min 3Xwk at 75 of maximum heart rate Resistance Training R 3Xweek progressing to 3 sets 8 repetitions of 8 exercises at the maximum load that can be lifted 8 times 8RM both Aerobic Training and Resistance Training AR or waiting-list control C The exercise intervention will take place at YMCAs in metropolitan Ottawa Subjects cannot be blinded as to group assignment after randomization but the main study outcomes will be measured by blinded individuals lab technologists using objective methods Subjects randomized to waiting list control will begin a program of their choice A R or AR after all 6-month outcome measures are collected
Significance This study addresses questions of clinical and scientific importance It will help clarify the benefits and risks of aerobic and resistance exercise training in people with type 1 diabetes Depending on the strength of any differences found the study will either stand alone or provide pilot data that will set the stage for a larger definitive study Even if results are substantially different from our expectations this study will provide valuable new information on the effects of different exercise modalities on metabolic control body composition cardiovascular risk factors and quality of life in this high-risk population
The acute effects of resistance exercise on glycemia in type 1 diabetes have not been established it is possible that resistance exercise results in a smoother or more predictable decline in blood glucose than aerobic training does which might reduce fear of hypoglycemia and consequent overcompensation Resistance exercise training increases insulin receptor protein expression which is not true of aerobic exercise training
Study Design This will be a randomized controlled trial with a 2 by 2 factorial design resistance training versus no resistance training aerobic training versus no aerobic training in previously inactive subjects with type 1 diabetes After screening qualifying subjects will enter a 5-week stabilizationrun in period prior to randomization During this period their diet and insulin therapy will be assessed and optimized and in weeks 2-5 they will also undergo three supervised sessions of low-intensity exercise per week Those demonstrating adequate compliance during the run-in period will then be randomized in equal numbers to Aerobic Training A progressing to 45 min 3Xwk at 75 of maximum heart rate Resistance Training R 3Xweek progressing to 3 sets 8 repetitions of 8 exercises at the maximum load that can be lifted 8 times 8RM both Aerobic Training and Resistance Training AR or waiting-list control C The exercise intervention will take place at YMCAs in metropolitan Ottawa Subjects cannot be blinded as to group assignment after randomization but the main study outcomes will be measured by blinded individuals lab technologists using objective methods Subjects randomized to waiting list control will begin a program of their choice A R or AR after all 6-month outcome measures are collected
Significance This study addresses questions of clinical and scientific importance It will help clarify the benefits and risks of aerobic and resistance exercise training in people with type 1 diabetes Depending on the strength of any differences found the study will either stand alone or provide pilot data that will set the stage for a larger definitive study Even if results are substantially different from our expectations this study will provide valuable new information on the effects of different exercise modalities on metabolic control body composition cardiovascular risk factors and quality of life in this high-risk population
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