Italian diabetes exercise study: a 20-center randomised controlled clinical trial designed to evaluate the safety and efficacy of intensive lifestyle intervention on controllable cardiovascular risk factors in type 2 diabetic subjects with metabolic syndrome

ISRCTN ISRCTN04252749
DOI https://doi.org/10.1186/ISRCTN04252749
Secondary identifying numbers N/A
Submission date
04/08/2005
Registration date
19/09/2005
Last edited
28/04/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stefano Balducci
Scientific

Via Montesanto, snc
Monterotondo, Roma
00016
Italy

Phone +39 (0)6 9004559
Email s.balducci@hctdiabete.it

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleItalian diabetes exercise study: a 20-center randomised controlled clinical trial designed to evaluate the safety and efficacy of intensive lifestyle intervention on controllable cardiovascular risk factors in type 2 diabetic subjects with metabolic syndrome
Study acronymIDES
Study objectivesThis study is designed to determine whether an intensive lifestyle intervention of exercise training, prescribed and supervised, as well as standard care, improves the controllable cardiovascular risk factors in type 2 diabetic subjects with metabolic syndrome, as compared with simple counselling program.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedDiabetes and metabolic syndrome.
InterventionPatients recruited to the study are assigned randomly to an exercise prescription (aerobic + strength) intervention
Control: Exercise counselling
Intervention typeBehavioural
Primary outcome measureThe Primary Endpoint will be to determine the numbers of patients within two groups that after 12 months achieve a % rate reduction of the following parameters: Hba1c = ≥–15%, Cholesterol - low density lipoprotein (LDL) = ≥–15%, Triglyceride = ≥–15%, Cholesterol - high density lipoprotein (HDL) = ≥+15%, Blood Pressure = ≥–5 mmHg x diastolic and systolic, BMI = BMI reduction ≥7% for patients with BMI ≥27, Waist ≥-10%
Secondary outcome measuresSecondary endpoints are the numbers of patients within two groups that after 12 months, achieve set standards of
1. Well-being
2. Dose/response between volume and intensity of exercise training and controllable cardiovascular risk factors
3. Impact of Exercise training on: coagulation and inflammation markers, endothelial function
4. The frequency of medication for three classes of drugs (hypolipemic, hypoglycemic, and antihypertensive therapies)
5. 10-year coronary heart disease (CHD) risk (as calculated from Framingham risk tables)
6. Cost analysis: Direct medical costs and Direct and Indirect social costs
Overall study start date30/09/2005
Completion date31/01/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants500
Key inclusion criteriaType 2 diabetes patients with metabolic syndrome, age from 40 to 80 years, duration of diabetes >1 year, body mass index (BMI) ≥27, ≤40, sedentary for at least six months, able to walk without assistance and eligible after cardiovascular algorithm evaluation. Of these, only those who give written informed consent.
Key exclusion criteriaPatients having at least one of the following conditions will be excluded from the study:
1. A history or evidence on physical examination of significant central nervous system dysfunction (i.e. hemiparesis, myelopathy, cerebellar ataxia)
2. Significant musculoskeletal deformity (i.e. amputation, scoliosis, abnormality of range of motion [ROM]) that would prevent participation (<90° of humeral abduction, inability to grip, <10° of combined ankle inversion/eversion)
3. Lower extremity arthritis or pain that limits exercise
4. History or clinical evidence of severe cardiovascular diseases that limit or contraindicate the exercise
5. A history or evidence on physical examination of vestibular dysfunction
6. A history of angina or angina equivalent symptoms (i.e. nausea, diaphoresis, shortness of breath with exercise)
7. Symptomatic postural hypotension defined as a fall in blood pressure (i.e. >20 mmHg for systolic or >10 mmHg for diastolic blood pressure) in response to postural change, from supine to standing
8. A history or evidence on physical examination of plantar skin pressure ulcer
Date of first enrolment30/09/2005
Date of final enrolment31/01/2007

Locations

Countries of recruitment

  • Italy

Study participating centre

Via Montesanto, snc
Monterotondo, Roma
00016
Italy

Sponsor information

Metabolic Fitness Association (Italy)
Not defined

Via Nomentana, 27
Monterotondo, Roma
00016
Italy

Phone +39 (0)6 90080260
Email info@metabolicfitness.it
Website http://www.metabolicfitness.it

Funders

Funder type

Industry

Metabolic Fitness Association (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2008 Yes No
Results article results 08/11/2010 Yes No
Results article results 28/11/2011 Yes No
Results article results 01/03/2012 Yes No
Results article results 01/06/2012 Yes No
Results article results 01/06/2012 Yes No
Results article results 01/08/2014 Yes No