Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/08/2005
Date assigned
19/09/2005
Last edited
28/11/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

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

http://www.metabolicfitness.it

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

Results - basic reporting

Publication summary

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

Publication citations

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Additional files

Editorial Notes