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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
History of Changes
  Purpose

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 Intervention
Type 2 Diabetes Mellitus
 Behavioral: Group based non-pharmacological rehabilitation
Behavioral: Individual non-pharmacological rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: "The Effect of Rehabilitation of Type 2 Diabetes Mellitus Versus Standard Outpatient Care." A Randomized Controlled Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Change in HgbA1c (Glycemic control) [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 180
Study Start Date: August 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00284609

Locations
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
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

Publications:

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

Responsible Party: Michael Røder, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT00284609     History of Changes
Other Study ID Numbers: (KF) 01 287360, 2005-41-6000, MPU 39-2005
Study First Received: January 17, 2006
Last Updated: March 25, 2010
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013