NCT00354237

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2005

Longer than P75 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2006

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

7.4 years

First QC Date

July 19, 2006

Last Update Submit

November 17, 2014

Conditions

Type 2 Diabetes MellitusCoronary Artery Disease

Keywords

diabetes mellituscardiac rehabilitationinsulin

Outcome Measures

Primary Outcomes (1)

  • 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).

    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.

    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).

    at the beginning and at the end of the cardiac rehabilitation programm

  • improvement of ventilatory threshold

    from the beginning and at the end of the cardiac rehabilitation programm

Study Arms (2)

B

OTHER

No intensive treatment

Other: Conventional antidiabetic treatment

A

EXPERIMENTAL

Intensive insulin treatment

Other: Intensive insulin treatment

Interventions

Conventional antidiabetic treatmentOTHER

No intensive treatment

B
Intensive insulin treatmentOTHER

Intensive insulin treatment

A

Eligibility Criteria

Age25 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus
  • recent Miocardial Infarction
  • HbA1c above 7%
  • enrolled in a cardiac rehabilitation program

You may not qualify if:

  • Type 1 diabetes
  • Coronary Bypass Surgery
  • Renal Failure (creatinine clearance below 30 ml/min)
  • severe Respiratory Failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Centre hospitalier du pays d'Aix

Aix-en-Provence, 13616, France

Location

Clinique Rhône Durance

Avignon, 84082, France

Location

Hôpital J Minjoz

Besançon, 25000, France

Location

CMC Bligny

Briis-sous-Forges, 91640, France

Location

centre de réadaptation cardiaque "Château le moine"

Cenon, 33150, France

Location

CHU du Bocage

Dijon, 21079, France

Location

Centre IRIS

Marcy-l'Étoile, 69280, France

Location

Centre Hospitalier de MONTBARD

Montbard, 21506, France

Location

Hopital BROUSSAIS, APHP

Paris, 75014, France

Location

Hôpital du haut Lévêque

Pessac, 33604, France

Location

Rééducation cardiovasculaire CRF Kerpape

Ploemeur, 56275, France

Location

Hôpital jeanne d'arc

Toul, 54201, France

Location

Related Publications (1)

  • 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.

    PMID: 26152221DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Coronary Artery DiseaseDiabetes MellitusInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesHyperinsulinism

Study Officials

  • Bruno L Vergès, Prof

    Centre Hospitalier Universitaire Dijon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 19, 2006

First Posted

July 20, 2006

Study Start

July 1, 2005

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

November 18, 2014

Record last verified: 2014-11

Locations

FR(12)