"The Effect of Rehabilitation of Type 2 Diabetes Mellitus Versus Standard Outpatient Care." A Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bispebjerg Hospital
- Enrollment
- 180
- Locations
- 2
- Primary Endpoint
- Change in HgbA1c (Glycemic control)
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in HgbA1c (Glycemic control)
Time Frame: baseline, six month, one year, two years and three years
Secondary Outcomes
- 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)