Rehabilitation of Type 2 Diabetes Patients.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Group based non-pharmacological rehabilitation
* Behavioral: Individual non-pharmacological rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Behavioral: Group based non-pharmacological rehabilitation<br>* 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<br>|
| Active Comparator: 2<br> | Behavioral: Individual non-pharmacological rehabilitation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes,, rehabilitation,, quality of life,, glycaemic control,, lifestyle intervention,, patient education,, physical training,, group visits,, reminders