Contact information
Type
Scientific
Primary contact
Dr Stefano Balducci
ORCID ID
Contact details
Via Montesanto
snc
Monterotondo
Roma
00016
Italy
+39 (0)6 9004559
s.balducci@hctdiabete.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific 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
Acronym
IDES
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Diabetes and metabolic syndrome.
Intervention
Patients recruited to the study are assigned randomly to an exercise prescription (aerobic + strength) intervention
Control: Exercise counselling
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
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 measures
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
Overall trial start date
30/09/2005
Overall trial end date
31/01/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
500
Participant 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
Recruitment start date
30/09/2005
Recruitment end date
31/01/2007
Locations
Countries of recruitment
Italy
Trial participating centre
Via Montesanto, snc
Monterotondo, Roma
00016
Italy
Sponsor information
Organisation
Metabolic Fitness Association (Italy)
Sponsor details
Via Nomentana
27
Monterotondo
Roma
00016
Italy
+39 (0)6 90080260
info@metabolicfitness.it
Sponsor type
Not defined
Website
Funders
Funder type
Industry
Funder name
Metabolic Fitness Association (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18061415
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/21059972
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/22123809
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22234648
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22399699
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23185314
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24566991
Publication citations
-
Results
Balducci S, Zanuso S, Massarini M, Corigliano G, Nicolucci A, Missori S, Cavallo S, Cardelli P, Alessi E, Pugliese G, Fallucca F, , The Italian Diabetes and Exercise Study (IDES): design and methods for a prospective Italian multicentre trial of intensive lifestyle intervention in people with type 2 diabetes and the metabolic syndrome., Nutr Metab Cardiovasc Dis, 2008, 18, 9, 585-595, doi: 10.1016/j.numecd.2007.07.006.
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Results
Balducci S, Zanuso S, Nicolucci A, De Feo P, Cavallo S, Cardelli P, Fallucca S, Alessi E, Fallucca F, Pugliese G, , Effect of an intensive exercise intervention strategy on modifiable cardiovascular risk factors in subjects with type 2 diabetes mellitus: a randomized controlled trial: the Italian Diabetes and Exercise Study (IDES)., Arch. Intern. Med., 2010, 170, 20, 1794-1803, doi: 10.1001/archinternmed.2010.380.
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Results
Nicolucci A, Balducci S, Cardelli P, Zanuso S, Pugliese G, , Improvement of quality of life with supervised exercise training in subjects with type 2 diabetes mellitus., Arch. Intern. Med., 2011, 171, 21, 1951-1953, doi: 10.1001/archinternmed.2011.561.
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Results
Nicolucci A, Balducci S, Cardelli P, Cavallo S, Fallucca S, Bazuro A, Simonelli P, Iacobini C, Zanuso S, Pugliese G, , Relationship of exercise volume to improvements of quality of life with supervised exercise training in patients with type 2 diabetes in a randomised controlled trial: the Italian Diabetes and Exercise Study (IDES)., Diabetologia, 2012, 55, 3, 579-588, doi: 10.1007/s00125-011-2425-9.
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Results
Balducci S, Zanuso S, Cardelli P, Salvi L, Mazzitelli G, Bazuro A, Iacobini C, Nicolucci A, Pugliese G, , Changes in physical fitness predict improvements in modifiable cardiovascular risk factors independently of body weight loss in subjects with type 2 diabetes participating in the Italian Diabetes and Exercise Study (IDES)., Diabetes Care, 2012, 35, 6, 1347-1354, doi: 10.2337/dc11-1859.
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Results
Balducci S, Zanuso S, Cardelli P, Salvi L, Bazuro A, Pugliese L, Maccora C, Iacobini C, Conti FG, Nicolucci A, Pugliese G, , Effect of high- versus low-intensity supervised aerobic and resistance training on modifiable cardiovascular risk factors in type 2 diabetes; the Italian Diabetes and Exercise Study (IDES)., PLoS ONE, 2012, 7, 11, e49297, doi: 10.1371/journal.pone.0049297.
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Results
Balducci S, Vulpiani MC, Pugliese L, D'Errico V, Menini S, Salerno G, Gargiulo L, Ferretti A, Pugliese G, Effect of supervised exercise training on musculoskeletal symptoms and function in patients with type 2 diabetes: the Italian Diabetes Exercise Study (IDES), Acta Diabetol, 2014 , 51, 4, 647-654, doi: 10.1007/s00592-014-0571-5.