Rehabilitation of Type 2 Diabetes Patients.
25 de março de 2010 atualizado por: Bispebjerg Hospital
"The Effect of Rehabilitation of Type 2 Diabetes Mellitus Versus Standard Outpatient Care." A Randomized Controlled Trial.
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.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
180
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Copenhagen NV
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Copenhagen, Copenhagen NV, Dinamarca, DK-2400
- Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 1
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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 |
|
Comparador Ativo: 2
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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 |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Change in HgbA1c (Glycemic control)
Prazo: baseline, six month, one year, two years and three years
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baseline, six month, one year, two years and three years
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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fasting total cholesterol, triglycerides, HDL and LDL,
Prazo: baseline, six month, one year, two years and three years
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baseline, six month, one year, two years and three years
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blood pressure,
Prazo: baseline, six month, one year, two years and three years
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baseline, six month, one year, two years and three years
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weight,
Prazo: baseline, six month, one year, two years and three years
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baseline, six month, one year, two years and three years
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waist circumference,
Prazo: baseline, six month, one year, two years and three years
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baseline, six month, one year, two years and three years
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fitness test,
Prazo: baseline, six month, one year, two years and three years
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baseline, six month, one year, two years and three years
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muscle strength test,
Prazo: baseline, six month, one year, two years and three years
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baseline, six month, one year, two years and three years
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occurrence of complications,
Prazo: baseline, six month, one year, two years and three years
|
baseline, six month, one year, two years and three years
|
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inflammatory markers,
Prazo: baseline, six month, one year, two years and three years
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baseline, six month, one year, two years and three years
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beta-cell function test (HOMA-test),
Prazo: baseline, six month, one year, two years and three years
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baseline, six month, one year, two years and three years
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endothelia cell markers,
Prazo: Not yet known
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Not yet known
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use of medication
Prazo: baseline, six month, one year, two years and three years
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baseline, six month, one year, two years and three years
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cost-benefit.
Prazo: Not yet known
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Not yet known
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Change in Quality of Life
Prazo: baseline, six month, one year, two years and three years
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baseline, six month, one year, two years and three years
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Body mass index
Prazo: baseline, six month, one year, two years and three years
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baseline, six month, one year, two years and three years
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Eva S Vadstrup, MD, Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen
- Diretor de estudo: Michael Røder, DMSc, Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
- 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.
- 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. Erratum In: Am J Respir Crit Care Med. 2020 Feb 1;201(3):393.
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de agosto de 2006
Conclusão Primária (Real)
1 de março de 2010
Conclusão do estudo (Real)
1 de março de 2010
Datas de inscrição no estudo
Enviado pela primeira vez
17 de janeiro de 2006
Enviado pela primeira vez que atendeu aos critérios de CQ
31 de janeiro de 2006
Primeira postagem (Estimativa)
1 de fevereiro de 2006
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
26 de março de 2010
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de março de 2010
Última verificação
1 de janeiro de 2009
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- (KF) 01 287360
- 2005-41-6000
- MPU 39-2005
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .