Diabetes Mellitus, Type 2NCT00195884
Diabetes Aerobic and Resistance Exercise (DARE) Study
A study testing Aerobic and Resistance Exercise in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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]… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes Mellitus
- What is being tested?
- Aerobic and Resistance Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 1 siteCanada
- Study dates
- Sep 1999to Apr 2011
- Phase
- Interventional
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus as defined by the 1998 CDA Guidelines
- Male or female
- treated with diet and/or oral agents (no insulin)
- age 40-70
- HbA1c 0.066-0.099
Who cannot join
- Participation during the previous 6 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 during the previous 6 months
- Insulin therapy, or uncontrolled hyperglycemia (HbA1c>0.099). Insulin therapy is an exclusion criterion because it would render HOMA insulin sensitivity calculation invalid.
- Changes in medications for diabetes, BP or lipids in the 2 months prior to enrollment.
- Significant weight change (increase or decrease of greater than 5% of body weight during the two months before enrollment).
- Significant renal disease: serum creatinine greater than 200 mEq/l. or proteinuria >1 g/24 hours.
- Uncontrolled hypertension: BP >160 mm Hg systolic or >95 mm Hg diastolic BP in a sitting position.
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- 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.
- Other illness, judged by the patient or study physician to make participation in this study inadvisable.
- Significant 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
Official title: Resistance Exercise as an Intervention in Type 2 Diabetes Mellitus
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-B/A1 ratio, low density lipoprotein (LDL) particle diameter, high-sensitivity C-reactive protein) and quality of life.
Read the 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 0.9% 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:
- 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?
- 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, total/HDL cholesterol ratio, BP)?
- 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.
- Conditions
- Diabetes Mellitus, Type 2, Diabetes Mellitus
- Being tested
- Aerobic and Resistance Exercise
- Keywords
- Diabetes Mellitus, Type 2 Diabetes, Aerobic, Resistance, weight training, Exercise
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic and Resistance ExerciseBehavioural
Also called non applicable
Aerobic activities are performed on a cycle ergometer or treadmill. Exercise intensity is standardized using Polar Heart rate monitors that display the subject's heart rate.
Resistance training:Exercises are performed at weight machines arranged in a circuit. Throughout the resistance training program, subjects will alternate between the exercises of group A and group B below.
Group A: abdominal crunches, seated row, seated biceps curls, supine bench press, leg press, shoulder press; leg extension Group B: abdominal crunches, lat pulldown, sitting chest press, leg press, upright row, triceps pushdown, leg curls.
Combined aerobic and resistance training group will perform both aerobic and resistance training programs, as described above.
Control: members of this group are asked to revert to their pre-study activity levels for 5 months, at which point they begin the combined aerobic and resistance exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Group | Experimental | Aerobic training is divided into three stages: the Starter phase (during the run-in period), the Progression phase, and the Maintenance phase. All aerobic activities are performed on a cycle ergometer, treadmill, elliptical exercise machine or stairclimber. Subjects are free to vary the machine(s) used from one visit to the next. Exercise intensity is standardized using Polar Heartminder heart rate monitors that display the subject's heart rate and emits a warming signal when heart rate is outside the prescribed training zone, thus guiding the subject in adjustment of the work load up or down to achieve the desired intensity. Receives: Behavioral: Aerobic and Resistance Exercise |
| Resistance Group | Experimental | Exercises are performed at weight machines arranged in a circuit. Throughout the resistance training program, subjects will alternate between the exercises of group A and group B below.
* Group A: abdominal crunches, seated row (back), seated biceps curls, supine bench press (chest), leg press, shoulder press (shoulders and neck); leg extension (quadriceps)
* Group B: abdominal crunches, lat pulldown (back), sitting chest press (chest), leg press, upright row (shoulders and neck), triceps pushdown, leg curls (hamstrings).
Subjects are instructed to exhale while lifting a weight and inhale while lowering it, in order to minimize blood pressure excursions. Warm-up and cooldown are the same as for aerobic training. Receives: Behavioral: Aerobic and Resistance Exercise |
| Combined Aerobic and Resistance Training | Experimental | Combined aerobic and resistance training. This group will perform both aerobic and resistance training programs, as described above. The aerobic and resistance components are performed on the same days, in varying orders. Receives: Behavioral: Aerobic and Resistance Exercise |
| Control Group | No intervention | Members of this group are asked to revert to their pre-study activity levels for 5 months, at which point they begin the combined aerobic and resistance exercise program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin A1c (HbA1c)
Measured pre and post intervention
Measured: 6-months
Secondary outcomes (5)
Body composition (CT scan)
Measured pre and post intervention
Measured: 6-months
resting energy expenditure
Measured pre and post intervention
Measured: 6-months
LDL particle diameter, insulin, CRP, FFA, HDL, LDL, Total chol./HDL ratio, triglycerides
Measured pre and post intervention
Measured: 6-months
Blood Pressure
Measured pre and post intervention
Measured: 6-months
quality of life (QOL)
Measured pre and post intervention
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 1999
- Primary completionMar 2005
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of Ottawa, Canadian Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Ronald J Sigal, MD MPH FRCPC, Principal investigator, Ottawa Hospital Research Institute, Ottawa Hospital, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00195884
- Sponsor's protocol ID
- MCT-44155
- Status last verified
- Jan 2013
- First submitted
- 12 Sep 2005
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Sigal RJ, Kenny GP, Wasserman DH, Castaneda-Sceppa C. Physical activity/exercise and type 2 diabetes. Diabetes Care. 2004 Oct;27(10):2518-39. doi: 10.2337/diacare.27.10.2518. No abstract available.
PubMed 15451933Boule NG, Haddad E, Kenny GP, Wells GA, Sigal RJ. Effects of exercise on glycemic control and body mass in type 2 diabetes mellitus: a meta-analysis of controlled clinical trials. JAMA. 2001 Sep 12;286(10):1218-27. doi: 10.1001/jama.286.10.1218.
PubMed 11559268Terada T, Boule NG, Forhan M, Prado CM, Kenny GP, Prud'homme D, Ito E, Sigal RJ. Cardiometabolic risk factors in type 2 diabetes with high fat and low muscle mass: At baseline and in response to exercise. Obesity (Silver Spring). 2017 May;25(5):881-891. doi: 10.1002/oby.21808. Epub 2017 Mar 20.
PubMed 28317297Gavin C, Sigal RJ, Cousins M, Menard ML, Atkinson M, Khandwala F, Kenny GP, Proctor S, Ooi TC; Diabetes Aerobic and Resistance Exercise (DARE) trial investigators. Resistance exercise but not aerobic exercise lowers remnant-like lipoprotein particle cholesterol in type 2 diabetes: a randomized controlled trial. Atherosclerosis. 2010 Dec;213(2):552-7. doi: 10.1016/j.atherosclerosis.2010.08.071. Epub 2010 Sep 27.
PubMed 20870234Reid RD, Tulloch HE, Sigal RJ, Kenny GP, Fortier M, McDonnell L, Wells GA, Boule NG, Phillips P, Coyle D. Effects of aerobic exercise, resistance exercise or both, on patient-reported health status and well-being in type 2 diabetes mellitus: a randomised trial. Diabetologia. 2010 Apr;53(4):632-40. doi: 10.1007/s00125-009-1631-1. Epub 2009 Dec 13.
PubMed 20012857Sigal RJ, Kenny GP, Boule NG, Wells GA, Prud'homme D, Fortier M, Reid RD, Tulloch H, Coyle D, Phillips P, Jennings A, Jaffey J. Effects of aerobic training, resistance training, or both on glycemic control in type 2 diabetes: a randomized trial. Ann Intern Med. 2007 Sep 18;147(6):357-69. doi: 10.7326/0003-4819-147-6-200709180-00005.
PubMed 17876019
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Exercise as an Intervention in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00195884
- Acronym / sponsor ID
- MCT-44155
- Conditions
- Diabetes Mellitus, Type 2, Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Type 2 Diabetes, Aerobic, Resistance, weight training, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of Ottawa, Canadian Diabetes Association
- Study start
- Sep 1999
- Primary completion
- Mar 2005 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 20 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.
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-B/A1 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 0.9% 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:
- 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?
- 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, total/HDL cholesterol ratio, BP)?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aerobic Group | Experimental | Behavioral: Aerobic and Resistance ExerciseAerobic training is divided into three stages: the Starter phase (during the run-in period), the Progression phase, and the Maintenance phase. All aerobic activities are performed on a cycle ergometer, treadmill, elliptical exercise machine or stairclimber. Subjects are free to vary the machine(s) used from one visit to the next. Exercise intensity is standardized using Polar Heartminder heart rate monitors that display the subject's heart rate and emits a warming signal when heart rate is outside the prescribed training zone, thus guiding the subject in adjustment of the work load up or down to achieve the desired intensity. |
| Resistance Group | Experimental | Behavioral: Aerobic and Resistance ExerciseExercises are performed at weight machines arranged in a circuit. Throughout the resistance training program, subjects will alternate between the exercises of group A and group B below. * Group A: abdominal crunches, seated row (back), seated biceps curls, supine bench press (chest), leg press, shoulder press (shoulders and neck); leg extension (quadriceps) * Group B: abdominal crunches, lat pulldown (back), sitting chest press (chest), leg press, upright row (shoulders and neck), triceps pushdown, leg curls (hamstrings). Subjects are instructed to exhale while lifting a weight and inhale while lowering it, in order to minimize blood pressure excursions. Warm-up and cooldown are the same as for aerobic training. |
| Combined Aerobic and Resistance Training | Experimental | Behavioral: Aerobic and Resistance ExerciseCombined aerobic and resistance training. This group will perform both aerobic and resistance training programs, as described above. The aerobic and resistance components are performed on the same days, in varying orders. |
| Control Group | No intervention | –Members of this group are asked to revert to their pre-study activity levels for 5 months, at which point they begin the combined aerobic and resistance exercise program. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes mellitus as defined by the 1998 CDA Guidelines
- Male or female
- treated with diet and/or oral agents (no insulin)
- age 40-70
- HbA1c 0.066-0.099
Key exclusion criteria (12 listed)
- Participation during the previous 6 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 during the previous 6 months
- Insulin therapy, or uncontrolled hyperglycemia (HbA1c>0.099). Insulin therapy is an exclusion criterion because it would render HOMA insulin sensitivity calculation invalid.
- Changes in medications for diabetes, BP or lipids in the 2 months prior to enrollment.
- Significant weight change (increase or decrease of greater than 5% of body weight during the two months before enrollment).
- Significant renal disease: serum creatinine greater than 200 mEq/l. or proteinuria >1 g/24 hours.
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 |
|---|---|---|
| Aerobic and Resistance ExerciseAlso: non applicableAerobic activities are performed on a cycle ergometer or treadmill. Exercise intensity is standardized using Polar Heart rate monitors that display the subject's heart rate. Resistance training:Exercises are performed at weight machines arranged in a circuit. Throughout the resistance training program, subjects will alternate between the exercises of group A and group B below. Group A: abdominal crunches, seated row, seated biceps curls, supine bench press, leg press, shoulder press; leg extension Group B: abdominal crunches, lat pulldown, sitting chest press, leg press, upright row, triceps pushdown, leg curls. Combined aerobic and resistance training group will perform both aerobic and resistance training programs, as described above. Control: members of this group are asked to revert to their pre-study activity levels for 5 months, at which point they begin the combined aerobic and resistance exercise program. | Behavioural | Aerobic Group, Combined Aerobic and Resistance Training, Resistance Group |
Primary outcome
hemoglobin A1c (HbA1c)
Time frame: 6-months
Measured pre and post intervention
5 secondary outcomes
Body composition (CT scan)
Time frame: 6-months
resting energy expenditure
Time frame: 6-months
LDL particle diameter, insulin, CRP, FFA, HDL, LDL, Total chol./HDL ratio, triglycerides
Time frame: 6-months
Blood Pressure
Time frame: 6-months
quality of life (QOL)
Time frame: 6-months
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 Jan 2013.
- Background: PubMed 15451933Sigal RJ, Kenny GP, Wasserman DH, Castaneda-Sceppa C. Physical activity/exercise and type 2 diabetes. Diabetes Care. 2004 Oct;27(10):2518-39. doi: 10.2337/diacare.27.10.2518. No abstract available.
- Background: PubMed 11559268Boule NG, Haddad E, Kenny GP, Wells GA, Sigal RJ. Effects of exercise on glycemic control and body mass in type 2 diabetes mellitus: a meta-analysis of controlled clinical trials. JAMA. 2001 Sep 12;286(10):1218-27. doi: 10.1001/jama.286.10.1218.
- Derived from this study: PubMed 28317297Terada T, Boule NG, Forhan M, Prado CM, Kenny GP, Prud'homme D, Ito E, Sigal RJ. Cardiometabolic risk factors in type 2 diabetes with high fat and low muscle mass: At baseline and in response to exercise. Obesity (Silver Spring). 2017 May;25(5):881-891. doi: 10.1002/oby.21808. Epub 2017 Mar 20.
- Derived from this study: PubMed 20870234Gavin C, Sigal RJ, Cousins M, Menard ML, Atkinson M, Khandwala F, Kenny GP, Proctor S, Ooi TC; Diabetes Aerobic and Resistance Exercise (DARE) trial investigators. Resistance exercise but not aerobic exercise lowers remnant-like lipoprotein particle cholesterol in type 2 diabetes: a randomized controlled trial. Atherosclerosis. 2010 Dec;213(2):552-7. doi: 10.1016/j.atherosclerosis.2010.08.071. Epub 2010 Sep 27.
- Derived from this study: PubMed 20012857Reid RD, Tulloch HE, Sigal RJ, Kenny GP, Fortier M, McDonnell L, Wells GA, Boule NG, Phillips P, Coyle D. Effects of aerobic exercise, resistance exercise or both, on patient-reported health status and well-being in type 2 diabetes mellitus: a randomised trial. Diabetologia. 2010 Apr;53(4):632-40. doi: 10.1007/s00125-009-1631-1. Epub 2009 Dec 13.
- Derived from this study: PubMed 17876019Sigal RJ, Kenny GP, Boule NG, Wells GA, Prud'homme D, Fortier M, Reid RD, Tulloch H, Coyle D, Phillips P, Jennings A, Jaffey J. Effects of aerobic training, resistance training, or both on glycemic control in type 2 diabetes: a randomized trial. Ann Intern Med. 2007 Sep 18;147(6):357-69. doi: 10.7326/0003-4819-147-6-200709180-00005.
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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, MD MPH FRCPC principal investigator
Ottawa Hospital Research Institute, Ottawa Hospital, 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 study testing Aerobic and Resistance Exercise in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, 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 5 inclusion and 12 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 Jan 2013. 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.
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?
hemoglobin A1c (HbA1c) (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00195884, which also lists 6 linked publications.
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 Jan 2013.