Type 2 Diabetes MellitusNCT00354237
DARE: Diabetes in cArdiac REhabilitation
A study testing Conventional antidiabetic treatment and Intensive insulin treatment in people with Type 2 Diabetes Mellitus and Coronary Artery Disease, run by Centre Hospitalier Universitaire Dijon at 12 sites in France.
Trial summary
The aim of the DARE study is to see whether strict glycemic control during cardiac rehabilitation may ameliorate the improvement of exercise capacities (VO2 peak, peak workload, ventilatory threshold)in patients with type 2 diabetes with coronary artery disease. Read more about this study
- Who is it for?
- Ages 25 to 95 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Coronary Artery Disease
- What is being tested?
- Conventional antidiabetic treatment and Intensive insulin treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 12 sitesFrance
- Study dates
- Jul 2005to Dec 2012
- 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 25 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
- recent Miocardial Infarction
- HbA1c above 7%
- enrolled in a cardiac rehabilitation program
Who cannot join
- Type 1 diabetes
- Coronary Bypass Surgery
- Renal Failure (creatinine clearance below 30 ml/min)
- severe Respiratory Failure
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Centre hospitalier du pays d'Aix
Aix-en-Provence, 13616
Clinique Rhône Durance
Avignon, 84082
Hôpital J Minjoz
Besançon, 25000
CMC Bligny
Briis-sous-Forges, 91640
centre de réadaptation cardiaque "Château le moine"
Cenon, 33150
CHU du Bocage
Dijon, 21079
Centre IRIS
Marcy-l'Étoile, 69280
Centre Hospitalier de MONTBARD
Montbard, 21506
Hopital BROUSSAIS, APHP
Paris, 75014
Hôpital du haut Lévêque
Pessac, 33604
Rééducation cardiovasculaire CRF Kerpape
Ploemeur, 56275
Hôpital jeanne d'arc
Toul, 54201
About this study
Official title: Effect of Strict Glycemic Control on Improvement of Exercise Capacities (VO2 Peak, Peak Workload After Cardiac Rehabilitation, in Patients With Type 2 Diabetes Mellitus With Coronary Artery Disease.
The aim of the DARE study is to see whether strict glycemic control during cardiac rehabilitation may ameliorate the improvement of exercise capacities (VO2 peak, peak workload, ventilatory threshold)in patients with type 2 diabetes with coronary artery disease.
Read the detailed description
In a recent study, we showed that the benefit of cardiac rehabilitation on the improvement of exercise capacities (VO2 peak, peak workload, ventilatory threshold), after an acute coronary event, was significantly reduced in patients with type 2 diabetes. Moreover ,we showed, in multivariate analysis, that the worse improvement of the capacities to the effort after cardiac rehabilitation, was mainly related to hyperglycemia.
Because the improvement of exercise capacities after cardiac rehabilitation (in particular VO2 peak) has been shown to be an essential factor to reduce short- term and long-term morbidity and mortality, we may think that such benefit on reduction of morbidity and mortality may be significantly less in patients with diabetes.
Thus, we propose to carry out a multicentric intervention study, entitled DARE which goal is to see whether a strict glycemic control, during cardiac rehabilitation following an acute Myocardial Infarction (MI), is likely to improve, the results of cardiac rehabilitation on exercise capacities in patients with type 2 diabetes.
After arrival in cardiac rehabilitation, patients with diabetes, will be randomized into 2 groups: an "intensive treatment" group, in which the patients will treated by insulin under a basal-bolus regimen with strict glycemic control and a "conventional treatment" group, in which the previous anti-diabetic treatment will be continued.
- Conditions
- Type 2 Diabetes Mellitus, Coronary Artery Disease
- Being tested
- Conventional antidiabetic treatment, Intensive insulin treatment
- Keywords
- diabetes mellitus, cardiac rehabilitation, insulin
- Medical subject headings
- Diabetes Mellitus, Type 2, Coronary Artery Disease, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional antidiabetic treatmentOther
No intensive treatment
Intensive insulin treatmentOther
Intensive insulin treatment
| Study group | Role | What they receive |
|---|---|---|
| B | Other | No intensive treatment Receives: Other: Conventional antidiabetic treatment |
| A | Experimental | Intensive insulin treatment Receives: Other: Intensive insulin treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of peak VO2,
Effect of strict glycemic control during cardiac rehabilitation on improvement of peak VO2.For this purpose, we paln to compare first the 2 treatment groups (intensive vs. control) and second, 2 pre-specified glycemic control groups according to the final fructosamine level (below and above the median).
Measured: at the beginning and at the end of the cardiac rehabilitation programm
Secondary outcomes (3)
number of patients, in each group of treatment, having improved from at least 16% their peak VO2, after cardiac rehabilitation.
Measured: at the beginning and at the end of the cardiac rehabilitation programm
study of the influence of improvement of glycemic control on the results of cardiac rehabilitation on exercise capacities (peak of VO2, peak workload , ventilatory threshold).
Measured: at the beginning and at the end of the cardiac rehabilitation programm
improvement of ventilatory threshold
Effect of strict glycemic control during cardiac rehabilitation on improvement of ventilatory threshold
Measured: from the beginning and at the end of the cardiac rehabilitation programm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startJul 2005
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Bruno Vergès, Centre Hospitalier Universitaire Dijon
- Investigators
- Bruno L Vergès, Prof, Principal investigator, Centre Hospitalier Universitaire Dijon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354237
- Sponsor's protocol ID
- DGS2005/0130
- Status last verified
- Nov 2014
- First submitted
- 19 Jul 2006
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Verges B, Patois-Verges B, Iliou MC, Simoneau-Robin I, Bertrand JH, Feige JM, Douard H, Catargi B, Fischbach M; DARE Study group. Influence of glycemic control on gain in VO2 peak, in patients with type 2 diabetes enrolled in cardiac rehabilitation after an acute coronary syndrome. The prospective DARE study. BMC Cardiovasc Disord. 2015 Jul 8;15:64. doi: 10.1186/s12872-015-0055-8.
PubMed 26152221
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Strict Glycemic Control on Improvement of Exercise Capacities (VO2 Peak, Peak Workload After Cardiac Rehabilitation, in Patients With Type 2 Diabetes Mellitus With Coronary Artery Disease.
- ClinicalTrials.gov ID
- NCT00354237
- Acronym / sponsor ID
- DGS2005/0130
- Conditions
- Type 2 Diabetes Mellitus, Coronary Artery Disease
- Keywords
- diabetes mellitus, cardiac rehabilitation, insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Jul 2006 (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 aim of the DARE study is to see whether strict glycemic control during cardiac rehabilitation may ameliorate the improvement of exercise capacities (VO2 peak, peak workload, ventilatory threshold)in patients with type 2 diabetes with coronary artery disease.
Detailed description
In a recent study, we showed that the benefit of cardiac rehabilitation on the improvement of exercise capacities (VO2 peak, peak workload, ventilatory threshold), after an acute coronary event, was significantly reduced in patients with type 2 diabetes. Moreover ,we showed, in multivariate analysis, that the worse improvement of the capacities to the effort after cardiac rehabilitation, was mainly related to hyperglycemia.
Because the improvement of exercise capacities after cardiac rehabilitation (in particular VO2 peak) has been shown to be an essential factor to reduce short- term and long-term morbidity and mortality, we may think that such benefit on reduction of morbidity and mortality may be significantly less in patients with diabetes.
Thus, we propose to carry out a multicentric intervention study, entitled DARE which goal is to see whether a strict glycemic control, during cardiac rehabilitation following an acute Myocardial Infarction (MI), is likely to improve, the results of cardiac rehabilitation on exercise capacities in patients with type 2 diabetes.
After arrival in cardiac rehabilitation, patients with diabetes, will be randomized into 2 groups: an "intensive treatment" group, in which the patients will treated by insulin under a basal-bolus regimen with strict glycemic control and a "conventional treatment" group, in which the previous anti-diabetic treatment will be continued.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Other | Other: Conventional antidiabetic treatmentNo intensive treatment |
| A | Experimental | Other: Intensive insulin treatmentIntensive insulin treatment |
Who may qualify
- Ages
- 25 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes mellitus
- recent Miocardial Infarction
- HbA1c above 7%
- enrolled in a cardiac rehabilitation program
Key exclusion criteria (4 listed)
- Type 1 diabetes
- Coronary Bypass Surgery
- Renal Failure (creatinine clearance below 30 ml/min)
- severe Respiratory Failure
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 |
|---|---|---|
| Conventional antidiabetic treatmentNo intensive treatment | Other | B |
| Intensive insulin treatmentIntensive insulin treatment | Other | A |
Primary outcome
improvement of peak VO2,
Time frame: at the beginning and at the end of the cardiac rehabilitation programm
Effect of strict glycemic control during cardiac rehabilitation on improvement of peak VO2.For this purpose, we paln to compare first the 2 treatment groups (intensive vs. control) and second, 2 pre-specified glycemic control groups according to the final fructosamine level (below and above the median).
3 secondary outcomes
number of patients, in each group of treatment, having improved from at least 16% their peak VO2, after cardiac rehabilitation.
Time frame: at the beginning and at the end of the cardiac rehabilitation programm
study of the influence of improvement of glycemic control on the results of cardiac rehabilitation on exercise capacities (peak of VO2, peak workload , ventilatory threshold).
Time frame: at the beginning and at the end of the cardiac rehabilitation programm
improvement of ventilatory threshold
Time frame: from the beginning and at the end of the cardiac rehabilitation programm
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 18 Nov 2014.
- Derived from this study: PubMed 26152221Verges B, Patois-Verges B, Iliou MC, Simoneau-Robin I, Bertrand JH, Feige JM, Douard H, Catargi B, Fischbach M; DARE Study group. Influence of glycemic control on gain in VO2 peak, in patients with type 2 diabetes enrolled in cardiac rehabilitation after an acute coronary syndrome. The prospective DARE study. BMC Cardiovasc Disord. 2015 Jul 8;15:64. doi: 10.1186/s12872-015-0055-8.
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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.
Bruno L Vergès, Prof principal investigator
Centre Hospitalier Universitaire Dijon
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional antidiabetic treatment and Intensive insulin treatment in people with Type 2 Diabetes Mellitus and Coronary Artery Disease, run by Centre Hospitalier Universitaire Dijon at 12 sites in France.
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 4 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 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. 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?
improvement of peak VO2, (time frame: at the beginning and at the end of the cardiac rehabilitation programm). 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 NCT00354237, which also lists 1 linked publication.
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 18 Nov 2014.