Rehabilitation of Type 2 Diabetes Patients.

Type 2 Diabetes Mellitus Clinical Trial

Official title:

"The Effect of Rehabilitation of Type 2 Diabetes Mellitus Versus Standard Outpatient Care." A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00284609
• Other study ID #: (KF) 01 287360
• Secondary ID: 2005-41-6000MPU
• Status: Completed
• Phase: N/A
• First received: January 17, 2006
• Last updated: March 25, 2010
• Start date: August 2006
• Est. completion date: March 2010

Study information

• Verified date: January 2009
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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
• 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

Locations

Country	Name	City	State
Denmark	Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen	Copenhagen	Copenhagen NV

Sponsors (3)

Lead Sponsor	Collaborator
Bispebjerg Hospital	National Board of Health, Denmark, The Health and Care Committee, Copenhagen City Council

Country where clinical trial is conducted

Denmark, 

References & Publications (15)

Bigaard J, Tjønneland A, Thomsen BL, Overvad K, Heitmann BL, Sørensen TI. Waist circumference, BMI, smoking, and mortality in middle-aged men and women. Obes Res. 2003 Jul;11(7):895-903. — View Citation

Boulé 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. — View Citation

Boulé 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. — View Citation

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. — View Citation

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. — View Citation

GESICA Investigators. Randomised trial of telephone intervention in chronic heart failure: DIAL trial. BMJ. 2005 Aug 20;331(7514):425. — View Citation

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. — View Citation

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. — View Citation

Krotkiewski M, Lönnroth P, Mandroukas K, Wroblewski Z, Rebuffé-Scrive M, Holm G, Smith U, Björntorp 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HgbA1c (Glycemic control)		baseline, six month, one year, two years and three years	No
Secondary	fasting total cholesterol, triglycerides, HDL and LDL,		baseline, six month, one year, two years and three years	No
Secondary	blood pressure,		baseline, six month, one year, two years and three years	No
Secondary	weight,		baseline, six month, one year, two years and three years	No
Secondary	waist circumference,		baseline, six month, one year, two years and three years	No
Secondary	fitness test,		baseline, six month, one year, two years and three years	No
Secondary	muscle strength test,		baseline, six month, one year, two years and three years	No
Secondary	occurrence of complications,		baseline, six month, one year, two years and three years	No
Secondary	inflammatory markers,		baseline, six month, one year, two years and three years	No
Secondary	beta-cell function test (HOMA-test),		baseline, six month, one year, two years and three years	No
Secondary	endothelia cell markers,		Not yet known	No
Secondary	use of medication		baseline, six month, one year, two years and three years	No
Secondary	cost-benefit.		Not yet known	No
Secondary	Change in Quality of Life		baseline, six month, one year, two years and three years	No
Secondary	Body mass index		baseline, six month, one year, two years and three years	No