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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 10.1186/ISRCTN04252749
ClinicalTrials.gov identifier
EudraCT number
Public title 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
Scientific title
Acronym IDES
Serial number at source N/A
Study hypothesis This 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.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Italy
Disease/condition/study domain Diabetes and metabolic syndrome.
Participants - inclusion criteria Type 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.
Participants - exclusion criteria Patients 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
Anticipated start date 30/09/2005
Anticipated end date 31/01/2007
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 500
Interventions Patients recruited to the study are assigned randomly to an Exercise Prescription (Aerobic + strength) intervention
Control: Exercise counselling
Primary outcome measure(s) The 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 measure(s) Secondary 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
Sources of funding Metabolic Fitness Association (Italy)
Trial website
Publications 1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18061415
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21059972
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22123809
4. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22234648
5. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22399699
6. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23185314
Contact name Dr  Stefano  Balducci
  Address Via Montesanto, snc
  City/town Monterotondo, Roma
  Zip/Postcode 00016
  Country Italy
  Tel +39 (0)6 9004559
  Fax +39 (0)6 90080235
  Email s.balducci@hctdiabete.it
Sponsor Metabolic Fitness Association (Italy)
  Address Via Nomentana, 27
  City/town Monterotondo, Roma
  Zip/Postcode 00016
  Country Italy
  Tel +39 (0)6 90080260
  Fax +39 (0)6 90080235
  Email info@metabolicfitness.it
  Sponsor website: http://www.metabolicfitness.it
Date applied 04/08/2005
Last edited 28/11/2012
Date ISRCTN assigned 19/09/2005
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