Rehabilitation of Type 2 Diabetes Patients.

March 25, 2010 updated by: Bispebjerg Hospital

"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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen NV
      • Copenhagen, Copenhagen NV, Denmark, DK-2400
        • Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HgbA1c (Glycemic control)
Time Frame: baseline, six month, one year, two years and three years
baseline, six month, one year, two years and three years

Secondary Outcome Measures

Outcome Measure
Time Frame
fasting total cholesterol, triglycerides, HDL and LDL,
Time Frame: baseline, six month, one year, two years and three years
baseline, six month, one year, two years and three years
blood pressure,
Time Frame: baseline, six month, one year, two years and three years
baseline, six month, one year, two years and three years
weight,
Time Frame: baseline, six month, one year, two years and three years
baseline, six month, one year, two years and three years
waist circumference,
Time Frame: baseline, six month, one year, two years and three years
baseline, six month, one year, two years and three years
fitness test,
Time Frame: baseline, six month, one year, two years and three years
baseline, six month, one year, two years and three years
muscle strength test,
Time Frame: baseline, six month, one year, two years and three years
baseline, six month, one year, two years and three years
occurrence of complications,
Time Frame: baseline, six month, one year, two years and three years
baseline, six month, one year, two years and three years
inflammatory markers,
Time Frame: baseline, six month, one year, two years and three years
baseline, six month, one year, two years and three years
beta-cell function test (HOMA-test),
Time Frame: baseline, six month, one year, two years and three years
baseline, six month, one year, two years and three years
endothelia cell markers,
Time Frame: Not yet known
Not yet known
use of medication
Time Frame: baseline, six month, one year, two years and three years
baseline, six month, one year, two years and three years
cost-benefit.
Time Frame: Not yet known
Not yet known
Change in Quality of Life
Time Frame: baseline, six month, one year, two years and three years
baseline, six month, one year, two years and three years
Body mass index
Time Frame: baseline, six month, one year, two years and three years
baseline, six month, one year, two years and three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

January 17, 2006

First Submitted That Met QC Criteria

January 31, 2006

First Posted (Estimate)

February 1, 2006

Study Record Updates

Last Update Posted (Estimate)

March 26, 2010

Last Update Submitted That Met QC Criteria

March 25, 2010

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • (KF) 01 287360
  • 2005-41-6000
  • MPU 39-2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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