Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 diabetes,, rehabilitation,, quality of life,, glycaemic control,, lifestyle intervention,, patient education,, physical training,, group visits,, reminders
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.
Interventions
BEHAVIORALGroup based non-pharmacological rehabilitation
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
BEHAVIORALIndividual non-pharmacological rehabilitation
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
Sponsors
National Board of Health, Denmark
The Health and Care Committee, Copenhagen City Council
Bispebjerg Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HgbA1c (Glycemic control) | baseline, six month, one year, two years and three years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| weight, | baseline, six month, one year, two years and three years |
| fasting total cholesterol, triglycerides, HDL and LDL, | baseline, six month, one year, two years and three years |
| waist circumference, | 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 |
| blood pressure, | baseline, six month, one year, two years and three years |
Countries
Denmark
Outcome results
None listed