Type 2 Diabetes Mellitus Clinical Trial
Official title:
"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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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