Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
180 participants
INTERVENTIONAL
2006-08-31
2010-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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1
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
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* HgbA1c between 6,8 - 10,0%
* With or without one or more micro- and macrovascular or neurological complications.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Board of Health, Denmark
OTHER_GOV
The Health and Care Committee, Copenhagen City Council
UNKNOWN
Bispebjerg Hospital
OTHER
Responsible Party
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Bispebjerg Hospital
Principal Investigators
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Eva S Vadstrup, MD
Role: PRINCIPAL_INVESTIGATOR
Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen
Michael Røder, DMSc
Role: STUDY_DIRECTOR
Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen
Locations
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Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen
Copenhagen, Copenhagen NV, Denmark
Countries
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References
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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. doi: 10.1056/NEJMoa021778.
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.
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. doi: 10.1001/jama.286.10.1218.
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. doi: 10.1007/s00125-003-1160-2. 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. doi: 10.1007/BF00703130.
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. doi: 10.1097/00005768-199911001-00010.
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. doi: 10.2337/diacare.24.10.1821.
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. doi: 10.2337/diacare.25.7.1159.
GESICA Investigators. Randomised trial of telephone intervention in chronic heart failure: DIAL trial. BMJ. 2005 Aug 20;331(7514):425. doi: 10.1136/bmj.38516.398067.E0.
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. doi: 10.1136/bmj.311.7017.1401.
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. doi: 10.1001/jama.280.21.1843.
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. doi: 10.1053/euhj.2001.2889.
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. doi: 10.1038/oby.2003.123.
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. doi: 10.1164/ajrccm.158.5.9710086.
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.
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.
Other Identifiers
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2005-41-6000
Identifier Type: -
Identifier Source: secondary_id
MPU 39-2005
Identifier Type: -
Identifier Source: secondary_id
(KF) 01 287360
Identifier Type: -
Identifier Source: org_study_id
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