NCT01750333

Brief Summary

The aim of this study is to explore whether and how high circulating levels of endothelin-1 (ET-1) in obese and overweight children may contribute to impair adiponectin (Ad) production, release and vascular activity

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

December 17, 2012

Status Verified

December 1, 2012

Enrollment Period

11 months

First QC Date

December 12, 2012

Last Update Submit

December 12, 2012

Conditions

OBESITYEndothelial DysfunctionInsulin Resistance

Outcome Measures

Primary Outcomes (1)

  • Correlation between serum levels of ET-1 and Ad in lean, overweight and obese children

    12 months

Study Arms (3)

Lean children

Overweight Children (OW)

Obese children (Ob)

Eligibility Criteria

Age5 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

CHILDREN ATTENDING THE OUTPATIENT UNIT OF THE UNIVERSITY PEDIATRIC CLINIC

You may qualify if:

  • Children will be enrolled into lean, overweight or obese groups based on Body mass index (BMI) calculated according to standard methods. International standards for sex-and age-specific BMI centiles for subjects aged 2-18 years will be used. The 95th centile of BMI reference is the cut off point for childhood obesity. Overweight and obese children are defined as those with a BMI higher than the centile curves.

You may not qualify if:

  • presence of renal, liver and/or cardiovascular diseases;
  • hypertension;
  • metabolic and/or endocrine disorders;
  • genetic syndromes;
  • histories of chronic allergies, acute infectious or inflammatory diseases during the last 3 months preceding the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bari Medical School - Dept Biomedical Sciences and Human Oncology

Bari, 70124, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

* serum * plasma

MeSH Terms

Conditions

ObesityInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Monica Montagnani, MD, PhD

    University of Bari Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDIV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical School Faculty Member - Professor of Pharmacology

Study Record Dates

First Submitted

December 12, 2012

First Posted

December 17, 2012

Study Start

April 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

December 17, 2012

Record last verified: 2012-12

Locations

IT(1)