Rehabilitation of Type 2 Diabetes Patients. - Full Text View

Sponsors and Collaborators:	Bispebjerg Hospital National Board of Health, Denmark The Health and Care Committee, Copenhagen City Council
Information provided by:	Bispebjerg Hospital
ClinicalTrials.gov Identifier:	NCT00284609

Purpose

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.

Condition	Intervention
Type 2 Diabetes Mellitus	Behavioral: Group based non-pharmacological rehabilitation Behavioral: Individual non-pharmacological rehabilitation

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	"The Effect of Rehabilitation of Type 2 Diabetes Mellitus Versus Standard Outpatient Care." A Randomized Controlled Trial.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Rehabilitation

U.S. FDA Resources

Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:

Change in HgbA1c (Glycemic control) [ Time Frame: baseline, six month, one year, two years and three years ]

Secondary Outcome Measures:

fasting total cholesterol, triglycerides, HDL and LDL, [ Time Frame: baseline, six month, one year, two years and three years ]
blood pressure, [ Time Frame: baseline, six month, one year, two years and three years ]
weight, [ Time Frame: baseline, six month, one year, two years and three years ]
waist circumference, [ Time Frame: baseline, six month, one year, two years and three years ]
fitness test, [ Time Frame: baseline, six month, one year, two years and three years ]
muscle strength test, [ Time Frame: baseline, six month, one year, two years and three years ]
occurrence of complications, [ Time Frame: baseline, six month, one year, two years and three years ]
inflammatory markers, [ Time Frame: baseline, six month, one year, two years and three years ]
beta-cell function test (HOMA-test), [ Time Frame: baseline, six month, one year, two years and three years ]
endothelia cell markers, [ Time Frame: Not yet known ]
use of medication [ Time Frame: baseline, six month, one year, two years and three years ]
cost-benefit. [ Time Frame: Not yet known ]
Change in Quality of Life [ Time Frame: baseline, six month, one year, two years and three years ]
Body mass index [ Time Frame: baseline, six month, one year, two years and three years ]

Estimated Enrollment:	180
Study Start Date:	August 2006
Estimated Study Completion Date:	February 2010

Arms	Assigned Interventions
1: Experimental	Behavioral: Group 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
2: Active Comparator	Behavioral: Individual 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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00284609

Contacts

Contact: Eva S Vadstrup, MD	+ 45 35 31 20 50	ev03@bbh.regionh.dk
Contact: Michael Røder, DMSc	+ 45 35 31 27 24	mr18@bbh.regionh.dk

Locations

Denmark, Copenhagen NV
Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen	Recruiting
Copenhagen, Copenhagen NV, Denmark, DK-2400
Contact: Eva Vadstrup, MD +45 35 31 20 50 ev03@bbh.regionh.dk
Contact: Michael Røder, MD +45 35 31 27 24 mr18@bbh.regionh.dk
Principal Investigator: Eva S Vadstrup, MD
Principal Investigator: Michael Røder, DMSc
Sub-Investigator: Anne Frølich, DMSc
Sub-Investigator: Hans L Perrild, DMSc
Sub-Investigator: Eva Borg, MPA

Sponsors and Collaborators

Bispebjerg Hospital

National Board of Health, Denmark

The Health and Care Committee, Copenhagen City Council

Investigators

Principal Investigator:	Eva S Vadstrup, MD	Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen
Study Director:	Michael Røder, DMSc	Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen

More Information

Publications:

Gaede P, Vedel P, Larsen N, Jensen GV, Parving HH, Pedersen O. Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med. 2003 Jan 30;348(5):383-93.

[No authors listed] Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53. Erratum in: Lancet 1999 Aug 14;354(9178):602.

Boule NG, Haddad E, Kenny GP, Wells GA, Sigal RJ. Effects of exercise on glycemic control and body mass in type 2 diabetes mellitus: a meta-analysis of controlled clinical trials. JAMA. 2001 Sep 12;286(10):1218-27. Review.

Boule NG, Kenny GP, Haddad E, Wells GA, Sigal RJ. Meta-analysis of the effect of structured exercise training on cardiorespiratory fitness in Type 2 diabetes mellitus. Diabetologia. 2003 Aug;46(8):1071-81. Epub 2003 Jul 10.

Krotkiewski M, Lonnroth P, Mandroukas K, Wroblewski Z, Rebuffe-Scrive M, Holm G, Smith U, Bjorntorp P. The effects of physical training on insulin secretion and effectiveness and on glucose metabolism in obesity and type 2 (non-insulin-dependent) diabetes mellitus. Diabetologia. 1985 Dec;28(12):881-90.

Yeater RA, Ullrich IH, Maxwell LP, Goetsch VL. Coronary risk factors in type II diabetes: response to low-intensity aerobic exercise. W V Med J. 1990 Jul;86(7):287-90.

Wing RR. Physical activity in the treatment of the adulthood overweight and obesity: current evidence and research issues. Med Sci Sports Exerc. 1999 Nov;31(11 Suppl):S547-52.

Renders CM, Valk GD, Griffin SJ, Wagner EH, Eijk Van JT, Assendelft WJ. Interventions to improve the management of diabetes in primary care, outpatient, and community settings: a systematic review. Diabetes Care. 2001 Oct;24(10):1821-33. Review.

Norris SL, Lau J, Smith SJ, Schmid CH, Engelgau MM. Self-management education for adults with type 2 diabetes: a meta-analysis of the effect on glycemic control. Diabetes Care. 2002 Jul;25(7):1159-71.

GESICA Investigators. Randomised trial of telephone intervention in chronic heart failure: DIAL trial. BMJ. 2005 Aug 20;331(7514):425.

Han TS, van Leer EM, Seidell JC, Lean ME. Waist circumference action levels in the identification of cardiovascular risk factors: prevalence study in a random sample. BMJ. 1995 Nov 25;311(7017):1401-5.

Rexrode KM, Carey VJ, Hennekens CH, Walters EE, Colditz GA, Stampfer MJ, Willett WC, Manson JE. Abdominal adiposity and coronary heart disease in women. JAMA. 1998 Dec 2;280(21):1843-8.

Lakka HM, Lakka TA, Tuomilehto J, Salonen JT. Abdominal obesity is associated with increased risk of acute coronary events in men. Eur Heart J. 2002 May;23(9):706-13.

Bigaard J, Tjonneland A, Thomsen BL, Overvad K, Heitmann BL, Sorensen TI. Waist circumference, BMI, smoking, and mortality in middle-aged men and women. Obes Res. 2003 Jul;11(7):895-903.

Enright PL, Sherrill DL. Reference equations for the six-minute walk in healthy adults. Am J Respir Crit Care Med. 1998 Nov;158(5 Pt 1):1384-7.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Vadstrup ES, Frølich A, Perrild H, Borg E, Røder 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.

Study ID Numbers:	(KF) 01 287360, 2005-41-6000, MPU 39-2005
Study First Received:	January 17, 2006
Last Updated:	November 20, 2007
ClinicalTrials.gov Identifier:	NCT00284609 History of Changes
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Bispebjerg Hospital:

Type 2 diabetes,
rehabilitation,
quality of life,
glycaemic control,
lifestyle intervention,

patient education,
physical training,
group visits,
reminders

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Quality of Life

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on August 30, 2009