Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/10/2003
Date assigned
23/10/2003
Last edited
20/02/2008
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

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

Publication citations

Additional files

Editorial Notes