Italian Society of Endocrinology Prevention Study
| ISRCTN | ISRCTN28124664 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28124664 |
| Secondary identifying numbers | N/A |
- Submission date
- 16/10/2003
- Registration date
- 23/10/2003
- Last edited
- 20/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Pierpaolo De Feo
Scientific
Scientific
DIMI
Via E dal Pozzo
Perugia
06126
Italy
| Phone | +39 0755783673 |
|---|---|
| defeo@dimisem.med.unipg.it |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | ISEPS |
| Study objectives | Randomized controlled trial designed to test the hypothesis that an intensive life style intervention is able to prevent the metabolic syndrome in 20-50 years old subjects affected by visceral obesity. Follow-up 5 years. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Visceral obesity, metabolic syndrome |
| Intervention | Intervention: Individual intensive counseling to induce life-style change as described in detail in the article: "Validation of a counseling strategy to promote the adoption and the maintenance of physical activity by type 2 diabetic subject” by Di Loreto et al (PubMid reference PMID: 12547870) |
| Intervention type | Other |
| Primary outcome measure | Prevention of metabolic syndrome |
| Secondary outcome measures | Reduction of body weight Reduction of CHD risk |
| Overall study start date | 01/06/2004 |
| Completion date | 30/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 500 |
| Key inclusion criteria | Men and women with visceral obesity 20-50 years old Waist >88cm (women) Waist >102cm (men) Without metabolic syndrome (according to the Adult Treatment Panel III [ATPIII] classification) |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/2004 |
| Date of final enrolment | 30/06/2010 |
Locations
Countries of recruitment
- Italy
Study participating centre
DIMI
Perugia
06126
Italy
06126
Italy
Sponsor information
Italian Society of Endocrinology
Research organisation
Research organisation
c/o Fasi Congress
Viale Gorizia, 24
Roma
00198
Italy
| Phone | +39 068540296 |
|---|---|
| defeo@dimisem.med.unipg.it |
Funders
Funder type
Research organisation
Foundation of Italian Society of Endocrinology
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 |
