Rehabilitation of Type 2 Diabetes Patients.

NCT00284609 | Completed

• 3 other identifiers: (KF) 01 2873602005-41-6000MPU 39-2005
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes,; rehabilitation,; quality of life,; glycaemic control,; lifestyle intervention,; patient education,; physical training,; group visits,; reminders

Outcome Measures

Primary Outcomes (1)

• Change in HgbA1c (Glycemic control)

  baseline, six month, one year, two years and three years

Secondary Outcomes (14)

• 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

• 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

Study Arms (2)

1

EXPERIMENTAL

Behavioral: Group based non-pharmacological rehabilitation

2

ACTIVE COMPARATOR

Behavioral: Individual non-pharmacological rehabilitation

Interventions

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

1

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• National Board of Health, Denmark: collaborator
• The Health and Care Committee, Copenhagen City Council: collaborator

Study Sites (1)

Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen

Copenhagen, Copenhagen NV, DK-2400, Denmark

Location

Related Publications (17)

• 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.

  PMID: 12556541 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.

  PMID: 9742976 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.

  PMID: 11559268 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.

  PMID: 12856082 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.

  PMID: 3912243 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.

  PMID: 2368376 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.

  PMID: 10593526 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.

  PMID: 11574449 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.

  PMID: 12087014 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.

  PMID: 16061499 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.

  PMID: 8520275 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.

  PMID: 9846779 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.

  PMID: 11977996 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.

  PMID: 12855760 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.

  PMID: 9817683 BACKGROUND

• 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.

  PMID: 20702058 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.

  PMID: 19480671 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 17, 2006
• First Posted: February 1, 2006
• Study Start: August 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 26, 2010

Record last verified: 2009-01

Locations

DK (1)