Contact information
Type
Scientific
Primary contact
Prof Pierpaolo De Feo
ORCID ID
Contact details
DIMI
Via E dal Pozzo
Perugia
06126
Italy
+39 0755783673
defeo@dimisem.med.unipg.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
ISEPS
Study hypothesis
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
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
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Prevention of metabolic syndrome
Secondary outcome measures
Reduction of body weight
Reduction of CHD risk
Overall trial start date
01/06/2004
Overall trial end date
30/06/2010
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
500
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/06/2004
Recruitment end date
30/06/2010
Locations
Countries of recruitment
Italy
Trial participating centre
DIMI
Perugia
06126
Italy
Sponsor information
Organisation
Italian Society of Endocrinology
Sponsor details
c/o Fasi Congress
Viale Gorizia
24
Roma
00198
Italy
+39 068540296
defeo@dimisem.med.unipg.it
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Foundation of Italian Society of Endocrinology
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