Rehabilitation of Type 2 Diabetes Patients.

• Change in HgbA1c (Glycemic control)
• Change in Quality of Life

• fasting total cholesterol, triglycerides, HDL and LDL, [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]
• blood pressure, [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]
• weight, [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]
• waist circumference, [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]
• fitness test, [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]
• muscle strength test, [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]
• occurrence of complications, [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]
• inflammatory markers, [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]
• beta-cell function test (HOMA-test), [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]
• endothelia cell markers, [ Time Frame: Not yet known ] [ Designated as safety issue: No ]
• use of medication [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]
• cost-benefit. [ Time Frame: Not yet known ] [ Designated as safety issue: No ]
• Change in Quality of Life [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]
• Body mass index [ Time Frame: baseline, six month, one year, two years and three years ] [ Designated as safety issue: No ]

• fasting total cholesterol, triglycerides, HDL and LDL,
• blood pressure,
• weight,
• BMI,
• waist circumference,
• fitness test,
• muscle strength test,
• occurrence of complications,
• inflammatory markers,
• beta-cell function test (HOMA-test),
• endothelia cell markers,
• use of medication
• cost-benefit.

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.

• 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

• 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

• Experimental: 1
  Intervention: Behavioral: Group based non-pharmacological rehabilitation
• Active Comparator: 2
  Intervention: Behavioral: Individual non-pharmacological rehabilitation

• 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.
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• Vadstrup ES, Frølich A, Perrild H, Borg E, Røder 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. Epub 2010 Aug 10.
• 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.

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

• National Board of Health, Denmark
• The Health and Care Committee, Copenhagen City Council