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Completed

NCT Number: NCT00284609

Rehabilitation of Type 2 Diabetes Patients.

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen

Copenhagen, Copenhagen NV, DK-2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group based non-pharmacological rehabilitation

Behavioral

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

Individual non-pharmacological rehabilitation

Behavioral

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

Primary outcomes

  1. Change in HgbA1c (Glycemic control)

    Time frame: baseline, six month, one year, two years and three years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • National Board of Health, Denmark
  • The Health and Care Committee, Copenhagen City Council

Registry information

Official study title

"The Effect of Rehabilitation of Type 2 Diabetes Mellitus Versus Standard Outpatient Care." A Randomized Controlled Trial.

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Feb 1, 2006
Registry last updated
Mar 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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