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Rehabilitation of Type 2 Diabetes Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00284609
Recruitment Status : Completed
First Posted : February 1, 2006
Last Update Posted : March 26, 2010
Sponsor:
Collaborators:
National Board of Health, Denmark
The Health and Care Committee, Copenhagen City Council
Information provided by:
Bispebjerg Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: Group based non-pharmacological rehabilitation Behavioral: Individual non-pharmacological rehabilitation Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: "The Effect of Rehabilitation of Type 2 Diabetes Mellitus Versus Standard Outpatient Care." A Randomized Controlled Trial.
Study Start Date : August 2006
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 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
Active Comparator: 2 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


Outcome Measures
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Primary Outcome Measures :
  1. Change in HgbA1c (Glycemic control) [ Time Frame: baseline, six month, one year, two years and three years ]

Secondary Outcome Measures :
  1. fasting total cholesterol, triglycerides, HDL and LDL, [ Time Frame: baseline, six month, one year, two years and three years ]
  2. blood pressure, [ Time Frame: baseline, six month, one year, two years and three years ]
  3. weight, [ Time Frame: baseline, six month, one year, two years and three years ]
  4. waist circumference, [ Time Frame: baseline, six month, one year, two years and three years ]
  5. fitness test, [ Time Frame: baseline, six month, one year, two years and three years ]
  6. muscle strength test, [ Time Frame: baseline, six month, one year, two years and three years ]
  7. occurrence of complications, [ Time Frame: baseline, six month, one year, two years and three years ]
  8. inflammatory markers, [ Time Frame: baseline, six month, one year, two years and three years ]
  9. beta-cell function test (HOMA-test), [ Time Frame: baseline, six month, one year, two years and three years ]
  10. endothelia cell markers, [ Time Frame: Not yet known ]
  11. use of medication [ Time Frame: baseline, six month, one year, two years and three years ]
  12. cost-benefit. [ Time Frame: Not yet known ]
  13. Change in Quality of Life [ Time Frame: baseline, six month, one year, two years and three years ]
  14. Body mass index [ Time Frame: baseline, six month, one year, two years and three years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284609


Locations
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Denmark
Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen
Copenhagen, Copenhagen NV, Denmark, DK-2400
Sponsors and Collaborators
Bispebjerg Hospital
National Board of Health, Denmark
The Health and Care Committee, Copenhagen City Council
Investigators
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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
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Michael Røder, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT00284609    
Other Study ID Numbers: (KF) 01 287360
2005-41-6000
MPU 39-2005
First Posted: February 1, 2006    Key Record Dates
Last Update Posted: March 26, 2010
Last Verified: January 2009
Keywords provided by Bispebjerg Hospital:
Type 2 diabetes,
rehabilitation,
quality of life,
glycaemic control,
lifestyle intervention,
 patient education,
physical training,
group visits,
reminders
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases