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 |
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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
Scientific
Via Montesanto, snc
Monterotondo, Roma
00016
Italy
Phone | +39 (0)6 9004559 |
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s.balducci@hctdiabete.it |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
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 |
Study acronym | IDES |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
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 study start date | 30/09/2005 |
Completion date | 31/01/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 500 |
Key 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. |
Key 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 |
Date of first enrolment | 30/09/2005 |
Date of final enrolment | 31/01/2007 |
Locations
Countries of recruitment
- Italy
Study participating centre
Via Montesanto, snc
Monterotondo, Roma
00016
Italy
00016
Italy
Sponsor information
Metabolic Fitness Association (Italy)
Not defined
Not defined
Via Nomentana, 27
Monterotondo, Roma
00016
Italy
Phone | +39 (0)6 90080260 |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |