Diabetes Mellitus, Type 1Phase 3NCT00148538
Type 1 Diabetes Aerobic and Resistance Exercise (T1-DARE)
A Phase 3 study testing Resistance and/or Aerobic Exercise in people with Diabetes Mellitus, Type 1, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Resistance and/or Aerobic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2005to Apr 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Type 1 diabetes mellitus as defined by the 2003 CDA guidelines (16) requiring insulin therapy starting within one year of diagnosis and continuously thereafter
- Male or female, age 16-45 years, A1c 0.066-0.090
- Physically inactive (see exclusion criteria below)
- Willingness and ability to work closely with the study physicians, nurse and dietitian and follow intensive diabetes therapy including carbohydrate counting, glucose monitoring ≥ 4 times per day, and intensive insulin therapy--either by multiple daily injections (MDI--insulin aspart or lispro before meals and NPH or insulin glargine 1-2X/day) or continuous subcutaneous insulin infusion (CSII) by pump therapy using insulin aspart or lispro for the duration of involvement in the study. CSII will only be an option for those already on CSII prior to entry in the study.
Who cannot join
- Participation during the previous 4 months in a regular program of exercise or aerobic sports greater than 2 times per week for at least 20 minutes per session, or in any resistance training.
- Hypoglycemia unawareness, or severe hypoglycemia requiring assistance from another person within the previous 3 months.
- "Brittle" diabetes, characterized by frequent and unpredictable hypoglycemia (even if not requiring assistance from others) and hyperglycemia.
- Restrictions in physical activity due to disease: intermittent claudication, severe peripheral neuropathy or active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, severe arthritis.
- Known or suspected clinically significant gastroparesis.
- Body mass index less than or equal to 32 kg/m2.
Show all 17Show fewer
- Fasting serum c-peptide less than 0.2 nmol/l.
- Recent significant weight change (increase or decrease of 5% of body weight during the two months before enrollment).
- An expected requirement within the subsequent 6 months for medications (other than insulin) that will affect glucose metabolism (e.g. corticosteroids).
- If age < 18 yr, linear growth of 1cm during the previous year.
- Significant renal disease: serum creatinine greater than 200 mEq/l. or proteinuria > 1 g/24 hours.
- Uncontrolled hypertension: BP > 150 mm Hg systolic or > 95 mm Hg diastolic in a sitting position.
- Other illness, judged by the patient or investigators to make participation in this study inadvisable.
- Cognitive deficit resulting in inability to understand or comply with instructions.
- Pregnancy at the start of the study, or intention to become pregnant in the next year.
- Inability to communicate in English or French.
- Unwillingness to sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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:
- 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).
- 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.
Read the 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 stabilization/run 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 3X/wk at 75% of maximum heart rate, Resistance Training (R) 3X/week 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Resistance and/or Aerobic Exercise
- Keywords
- Type 1 Diabetes, Resistance Exercise, Aerobic Exercise, Exercise & Disease, Exercise, Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity, Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance and/or Aerobic ExerciseBehavioural
Also called non applicable
Resistance and/or Aerobic Exercise
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | resistance exercise Receives: Behavioral: Resistance and/or Aerobic Exercise |
| 2 | Active comparator | Aerobic and Resistance exercise Receives: Behavioral: Resistance and/or Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c at the end of the 6-month exercise period
Measured: end of study
Secondary outcomes (10)
frequency of hypoglycemia
Measured: end of study
fructosamine
Measured: end of study
blood pressure
Measured: end of study
lipid concentrations
Measured: end of study
apolipoproteins A1 and B
Measured: end of study
C-reactive protein
Measured: end of study
FFA
Measured: end of study
body composition (CT & DEXA)
Measured: end of study
compliance with the exercise
Measured: end of study
quality of life
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionDec 2010
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald J Sigal, Principal investigator, The Ottawa Health Research Institute, The Ottawa Hospital, The University of OttawaGary Goldfield, Principal investigator, Children's Hospital of Eastern OntarioGlen Kenny, Principal investigator, University of OttawaStasia Hadjiyannakis, Principal investigator, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148538
- Sponsor's protocol ID
- GA-3-05-1903-RS
- Status last verified
- Jul 2019
- First submitted
- 6 Sep 2005
- Last updated
- 23 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 1 Diabetes Aerobic and Resistance Exercise (T1-DARE)
- ClinicalTrials.gov ID
- NCT00148538
- Acronym / sponsor ID
- GA-3-05-1903-RS
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Type 1 Diabetes, Resistance Exercise, Aerobic Exercise, Exercise & Disease, Exercise, Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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 stabilization/run 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 3X/wk at 75% of maximum heart rate, Resistance Training (R) 3X/week 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Resistance and/or Aerobic Exerciseresistance exercise |
| 2 | Active comparator | Behavioral: Resistance and/or Aerobic ExerciseAerobic and Resistance exercise |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 diabetes mellitus as defined by the 2003 CDA guidelines (16) requiring insulin therapy starting within one year of diagnosis and continuously thereafter
- Male or female, age 16-45 years, A1c 0.066-0.090
- Physically inactive (see exclusion criteria below)
- Willingness and ability to work closely with the study physicians, nurse and dietitian and follow intensive diabetes therapy including carbohydrate counting, glucose monitoring ≥ 4 times per day, and intensive insulin therapy--either by multiple daily injections (MDI--insulin aspart or lispro before meals and NPH or insulin glargine 1-2X/day) or continuous subcutaneous insulin infusion (CSII) by pump therapy using insulin aspart or lispro for the duration of involvement in the study. CSII will only be an option for those already on CSII prior to entry in the study.
Key exclusion criteria (17 listed)
- Participation during the previous 4 months in a regular program of exercise or aerobic sports greater than 2 times per week for at least 20 minutes per session, or in any resistance training.
- Hypoglycemia unawareness, or severe hypoglycemia requiring assistance from another person within the previous 3 months.
- "Brittle" diabetes, characterized by frequent and unpredictable hypoglycemia (even if not requiring assistance from others) and hyperglycemia.
- Restrictions in physical activity due to disease: intermittent claudication, severe peripheral neuropathy or active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, severe arthritis.
- Known or suspected clinically significant gastroparesis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance and/or Aerobic ExerciseAlso: non applicableResistance and/or Aerobic Exercise | Behavioural | 1, 2 |
Primary outcome
HbA1c at the end of the 6-month exercise period
Time frame: end of study
10 secondary outcomes
frequency of hypoglycemia
Time frame: end of study
fructosamine
Time frame: end of study
blood pressure
Time frame: end of study
lipid concentrations
Time frame: end of study
apolipoproteins A1 and B
Time frame: end of study
C-reactive protein
Time frame: end of study
FFA
Time frame: end of study
body composition (CT & DEXA)
Time frame: end of study
compliance with the exercise
Time frame: end of study
quality of life
Time frame: end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald J Sigal principal investigator
The Ottawa Health Research Institute, The Ottawa Hospital, The University of Ottawa
Gary Goldfield principal investigator
Children's Hospital of Eastern Ontario
Glen Kenny principal investigator
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Resistance and/or Aerobic Exercise in people with Diabetes Mellitus, Type 1, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c at the end of the 6-month exercise period (time frame: end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.