Type 2 Diabetes MellitusNCT00284609
Rehabilitation of Type 2 Diabetes Patients.
A study testing Group based non-pharmacological rehabilitation and Individual non-pharmacological rehabilitation in people with Type 2 Diabetes Mellitus, run by Bispebjerg Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Group based non-pharmacological rehabilitation and Individual non-pharmacological rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2006to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen
Copenhagen, Copenhagen NV, DK-2400
About this study
Official title: "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.
Read the detailed 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Group based non-pharmacological rehabilitation, Individual non-pharmacological rehabilitation
- Keywords
- Type 2 diabetes,, rehabilitation,, quality of life,, glycaemic control,, lifestyle intervention,, patient education,, physical training,, group visits,, reminders
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group based non-pharmacological rehabilitationBehavioural
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 rehabilitationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Group based non-pharmacological rehabilitation |
| 2 | Active comparator | Not described Receives: Behavioral: Individual non-pharmacological rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HgbA1c (Glycemic control)
Measured: baseline, six month, one year, two years and three years
Secondary outcomes (14)
fasting total cholesterol, triglycerides, HDL and LDL,
Measured: baseline, six month, one year, two years and three years
blood pressure,
Measured: baseline, six month, one year, two years and three years
weight,
Measured: baseline, six month, one year, two years and three years
waist circumference,
Measured: baseline, six month, one year, two years and three years
fitness test,
Measured: baseline, six month, one year, two years and three years
muscle strength test,
Measured: baseline, six month, one year, two years and three years
occurrence of complications,
Measured: baseline, six month, one year, two years and three years
inflammatory markers,
Measured: baseline, six month, one year, two years and three years
beta-cell function test (HOMA-test),
Measured: baseline, six month, one year, two years and three years
endothelia cell markers,
Measured: Not yet known
use of medication
Measured: baseline, six month, one year, two years and three years
cost-benefit.
Measured: Not yet known
Change in Quality of Life
Measured: baseline, six month, one year, two years and three years
Body mass index
Measured: baseline, six month, one year, two years and three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2006 (estimated)
- Study startAug 2006
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Board of Health, Denmark, The Health and Care Committee, Copenhagen City Council
- Investigators
- Eva S Vadstrup, MD, Principal investigator, Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of CopenhagenMichael Røder, DMSc, Study director, Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284609
- Sponsor's protocol ID
- (KF) 01 287360
- Other IDs
- 2005-41-6000, MPU 39-2005
- Status last verified
- Jan 2009
- First submitted
- 17 Jan 2006
- Last updated
- 26 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12556541Intensive 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.
PubMed 9742976Boule 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.
PubMed 11559268Boule 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.
PubMed 12856082Krotkiewski 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.
PubMed 3912243Yeater 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.
PubMed 2368376Wing 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.
PubMed 10593526Renders 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.
PubMed 11574449Norris 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.
PubMed 12087014GESICA 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.
PubMed 16061499Han 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.
PubMed 8520275Rexrode 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.
PubMed 9846779Lakka 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.
PubMed 11977996Bigaard 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.
PubMed 12855760Enright 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.
PubMed 9817683
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effect of Rehabilitation of Type 2 Diabetes Mellitus Versus Standard Outpatient Care." A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00284609
- Acronym / sponsor ID
- (KF) 01 287360
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes,, rehabilitation,, quality of life,, glycaemic control,, lifestyle intervention,, patient education,, physical training,, group visits,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- National Board of Health, Denmark, The Health and Care Committee, Copenhagen City Council
- Study start
- Aug 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 1 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Group based non-pharmacological rehabilitation |
| 2 | Active comparator | Behavioral: Individual non-pharmacological rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group based non-pharmacological rehabilitation6 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 | Behavioural | 1 |
| Individual non-pharmacological rehabilitationIndividual 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 | Behavioural | 2 |
Primary outcome
Change in HgbA1c (Glycemic control)
Time frame: baseline, six month, one year, two years and three years
14 secondary outcomes
fasting total cholesterol, triglycerides, HDL and LDL,
Time frame: baseline, six month, one year, two years and three years
blood pressure,
Time frame: baseline, six month, one year, two years and three years
weight,
Time frame: baseline, six month, one year, two years and three years
waist circumference,
Time frame: baseline, six month, one year, two years and three years
fitness test,
Time frame: baseline, six month, one year, two years and three years
muscle strength test,
Time frame: baseline, six month, one year, two years and three years
occurrence of complications,
Time frame: baseline, six month, one year, two years and three years
inflammatory markers,
Time frame: baseline, six month, one year, two years and three years
beta-cell function test (HOMA-test),
Time frame: baseline, six month, one year, two years and three years
endothelia cell markers,
Time frame: Not yet known
use of medication
Time frame: baseline, six month, one year, two years and three years
cost-benefit.
Time frame: Not yet known
Change in Quality of Life
Time frame: baseline, six month, one year, two years and three years
Body mass index
Time frame: baseline, six month, one year, two years and three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2010.
- Background: PubMed 12556541Gaede 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.
- Background: PubMed 9742976Intensive 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.
- Background: PubMed 11559268Boule 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.
- Background: PubMed 12856082Boule 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.
- Background: PubMed 3912243Krotkiewski 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.
- Background: PubMed 2368376Yeater 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.
- Background: PubMed 10593526Wing 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.
- Background: PubMed 11574449Renders 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.
- Background: PubMed 12087014Norris 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.
- Background: PubMed 16061499GESICA 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.
- Background: PubMed 8520275Han 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.
- Background: PubMed 9846779Rexrode 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva S Vadstrup, MD principal investigator
Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen
Michael Røder, DMSc study director
Endocrine Section, Dept Internal Medicine I, Bispebjerg Hospital, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group based non-pharmacological rehabilitation and Individual non-pharmacological rehabilitation in people with Type 2 Diabetes Mellitus, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HgbA1c (Glycemic control) (time frame: baseline, six month, one year, two years and three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00284609, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2010.