|
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
|
