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Rehabilitation of Type 2 Diabetes Patients.

This study has been completed.
Sponsor:
Collaborators:
National Board of Health, Denmark
The Health and Care Committee, Copenhagen City Council
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00284609
First received: January 17, 2006
Last updated: March 25, 2010
Last verified: January 2009

January 17, 2006
March 25, 2010
August 2006
March 2010   (final data collection date for primary outcome measure)
Change in HgbA1c (Glycemic control) [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]
  • Change in HgbA1c (Glycemic control)
  • Change in Quality of Life
Complete list of historical versions of study NCT00284609 on ClinicalTrials.gov Archive Site
  • fasting total cholesterol, triglycerides, HDL and LDL, [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]
  • blood pressure, [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]
  • weight, [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]
  • waist circumference, [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]
  • fitness test, [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]
  • muscle strength test, [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]
  • occurrence of complications, [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]
  • inflammatory markers, [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]
  • beta-cell function test (HOMA-test), [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]
  • endothelia cell markers, [ Time Frame: Not yet known ] [ Designated as safety issue: No ]
  • use of medication [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]
  • cost-benefit. [ Time Frame: Not yet known ] [ Designated as safety issue: No ]
  • Change in Quality of Life [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]
  • Body mass index [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]
  • fasting total cholesterol, triglycerides, HDL and LDL,
  • blood pressure,
  • weight,
  • BMI,
  • waist circumference,
  • fitness test,
  • muscle strength test,
  • occurrence of complications,
  • inflammatory markers,
  • beta-cell function test (HOMA-test),
  • endothelia cell markers,
  • use of medication
  • cost-benefit.
Not Provided
Not Provided
 
Rehabilitation of Type 2 Diabetes Patients.
"The Effect of Rehabilitation of Type 2 Diabetes Mellitus Versus Standard Outpatient Care." A Randomized Controlled Trial.

The aim of this study is to investigate the effect of a new rehabilitation program of type 2 diabetes patients in a primary care center versus standard care in the outpatient Hospital Clinic.

Type 2 diabetes is major and growing health care problem and is associated with premature mortality and increased morbidity. At the time of diagnosis half of the patients have cardiovascular, renal, ophthalmic or neurological disease. A recent Danish intervention study found a marked reduction in cardiovascular events and microvascular complications in a group of patients with type 2 diabetes and microalbuminuria using an intensive multifactorial pharmacologic intervention and lifestyle intervention (3). The achieved changes in lifestyle seems however to vanish after a short period. Lack of information, unawareness of the seriousness of the disease and lack of supervised training and insufficient follow-up may be of importance of the long-term outcome in these patients.

A total number of 180 patients with type 2 diabetes, will be randomized to the intervention group or to standard care.

This study tests an intensive intervention of lifestyle by a newly developed program of rehabilitation compared with routine standards in a randomized controlled design. Provided that a significant positive outcome is found, the non-pharmacologic treatment of type 2 diabetes could be optimized and inpatient hospitalization due to complications could be avoided.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Type 2 Diabetes Mellitus
  • Behavioral: Group based non-pharmacological rehabilitation

    6 x 1.5 hours education program in group classes taught by nurse, physiotherapist, dietitian and chiropodist.

    24 x 1.5 hours training program (both aerobic and anaerobic exercise) in group classes supervised by a physiotherapist.

    3 x 3 hours cooking sessions in group classes supervised by a dietitian.

    Intervention period: 6 month

  • Behavioral: Individual non-pharmacological rehabilitation

    Individual counseling in Outpatient Clinic, including patient education, physical activity and diet instruction.

    4 x 1 hour with a diabetes nurse,

    3 x 0.5 hour with a dietitian and

    1 hour with a chiropodist.

    Intervention period: 6 month

  • Experimental: 1
    Intervention: Behavioral: Group based non-pharmacological rehabilitation
  • Active Comparator: 2
    Intervention: Behavioral: Individual non-pharmacological rehabilitation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of Type 2 diabetes mellitus
  • HgbA1c between 6,8 - 10,0%
  • With or without one or more micro- and macrovascular or neurological complications.

Exclusion Criteria:

  • HgbA1c < 6,8 and > 10,0 %
  • Patients who have attended lifestyle intervention in the past year
  • Patients who is planned to start treatment with insulin during intervention period
  • Lack of motivation
  • Patients with severe heart-, liver or kidney disease or incurable cancer
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00284609
(KF) 01 287360, 2005-41-6000, MPU 39-2005
No
Michael Røder, Bispebjerg Hospital
Bispebjerg Hospital
  • National Board of Health, Denmark
  • The Health and Care Committee, Copenhagen City Council
Principal Investigator: Eva S Vadstrup, MD Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen
Study Director: Michael Røder, DMSc Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen
Bispebjerg Hospital
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP