Clinical trial NCT00284609: Rehabilitation of Type 2 Diabetes Patients.
Official title: "The Effect of Rehabilitation of Type 2 Diabetes Mellitus Versus Standard Outpatient Care." A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes,
rehabilitation,
quality of life,
glycaemic control,
lifestyle intervention,
patient education,
physical training,
group visits,
reminders
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: National Board of Health, Denmark
name: The Health and Care Committee, Copenhagen City Council
First posted: 2006-02-01
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in HgbA1c (Glycemic control)
timeFrame: baseline, six month, one year, two years and three years
Secondary outcomes:
measure: fasting total cholesterol, triglycerides, HDL and LDL,
timeFrame: baseline, six month, one year, two years and three years
measure: blood pressure,
timeFrame: baseline, six month, one year, two years and three years
measure: weight,
timeFrame: baseline, six month, one year, two years and three years
measure: waist circumference,
timeFrame: baseline, six month, one year, two years and three years
measure: fitness test,
timeFrame: baseline, six month, one year, two years and three years
measure: muscle strength test,
timeFrame: baseline, six month, one year, two years and three years
measure: occurrence of complications,
timeFrame: baseline, six month, one year, two years and three years
measure: inflammatory markers,
timeFrame: baseline, six month, one year, two years and three years
measure: beta-cell function test (HOMA-test),
timeFrame: baseline, six month, one year, two years and three years
measure: endothelia cell markers,
timeFrame: Not yet known
measure: use of medication
timeFrame: baseline, six month, one year, two years and three years
measure: cost-benefit.
timeFrame: Not yet known
measure: Change in Quality of Life
timeFrame: baseline, six month, one year, two years and three years
measure: Body mass index
timeFrame: baseline, six month, one year, two years and three years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen
state: Copenhagen NV
Study officials:
affiliation: Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen
name: Eva S Vadstrup, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen
name: Michael Røder, DMSc
role: STUDY_DIRECTOR
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citation: Vadstrup ES, Frolich A, Perrild H, Borg E, Roder M. Effect of a group-based rehabilitation programme on glycaemic control and cardiovascular risk factors in type 2 diabetes patients: the Copenhagen Type 2 Diabetes Rehabilitation Project. Patient Educ Couns. 2011 Aug;84(2):185-90. doi: 10.1016/j.pec.2010.06.031. Epub 2010 Aug 10.
citation: Vadstrup ES, Frolich A, Perrild H, Borg E, Roder M. Lifestyle intervention for type 2 diabetes patients: trial protocol of The Copenhagen Type 2 Diabetes Rehabilitation Project. BMC Public Health. 2009 May 29;9:166. doi: 10.1186/1471-2458-9-166.