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.
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
Allocation
RANDOMIZED
Masking
NONE
Enrollment
180
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 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
Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen
Copenhagen, Copenhagen NV, Denmark
Change in HgbA1c (Glycemic control)
Time frame: baseline, six month, one year, two years and three years
fasting total cholesterol, triglycerides, HDL and LDL,
Time frame: baseline, six month, one year, two years and three years
blood pressure,
Time frame: baseline, six month, one year, two years and three years
weight,
Time frame: baseline, six month, one year, two years and three years
waist circumference,
Time frame: baseline, six month, one year, two years and three years
fitness test,
Time frame: 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
occurrence of complications,
Time frame: baseline, six month, one year, two years and three years
inflammatory markers,
Time frame: 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
endothelia cell markers,
Time frame: Not yet known
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use of medication
Time frame: baseline, six month, one year, two years and three years
cost-benefit.
Time frame: Not yet known
Change in Quality of Life
Time frame: 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