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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-41-6000 | |||
| MPU 39-2005 |
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| Name | Class |
|---|---|
| National Board of Health, Denmark | OTHER_GOV |
| The Health and Care Committee, Copenhagen City Council | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group based non-pharmacological rehabilitation | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HgbA1c (Glycemic control) | baseline, six month, one year, two years and three years |
| Measure | Description | Time Frame |
|---|---|---|
| fasting total cholesterol, triglycerides, HDL and LDL, | baseline, six month, one year, two years and three years | |
| blood pressure, | baseline, six month, one year, two years and three years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva S Vadstrup, MD | Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen | Principal Investigator |
| Michael Røder, DMSc | Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen | Copenhagen | Copenhagen NV | DK-2400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12556541 | Background | 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. | |
| 9742976 | Background | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Individual non-pharmacological rehabilitation | Behavioral | 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 |
|
| weight, |
| baseline, six month, one year, two years and three years |
| waist circumference, | baseline, six month, one year, two years and three years |
| 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 |
| 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 |
| 11559268 | Background | 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. |
| 12856082 | Background | 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. |
| 3912243 | Background | 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. |
| 2368376 | Background | 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. |
| 10593526 | Background | 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. |
| 11574449 | Background | 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. |
| 12087014 | Background | 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. |
| 16061499 | Background | 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. |
| 8520275 | Background | 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. |
| 9846779 | Background | 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. |
| 11977996 | Background | 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. |
| 12855760 | Background | 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. |
| 9817683 | Background | 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. |
| 20702058 | Derived | 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. |
| 19480671 | Derived | 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. |
| D004700 | Endocrine System Diseases |