Rehabilitation of Type 2 Diabetes Patients.

Bispebjerg Hospital

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Behavioral: Individual non-pharmacological rehabilitation; Behavioral: Group based non-pharmacological rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT00284609

(KF) 01 287360

2005-41-6000

MPU 39-2005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

180 participants in 2 patient groups

1

Experimental group

Treatment:

Behavioral: Group based non-pharmacological rehabilitation

2

Active Comparator group

Treatment:

Behavioral: Individual non-pharmacological rehabilitation