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Study on Correlation Between Vascular ET-1 and Adiponectin in Pediatric Obesity

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Monica Montagnani, Montagnani, Monica, M.D., Ph.D.
ClinicalTrials.gov Identifier:
NCT01750333
First received: December 12, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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


Condition
OBESITY
Endothelial Dysfunction
Insulin Resistance

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observational Retrospective Study on Correlation Between ET-1 and Ad in Obese Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Montagnani, Monica, M.D., Ph.D.:

Primary Outcome Measures:
  • Correlation between serum levels of ET-1 and Ad in lean, overweight and obese children [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
  • serum
  • plasma

Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Lean children
Overweight Children (OW)
Obese children (Ob)

  Eligibility

Ages Eligible for Study:   5 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

CHILDREN ATTENDING THE OUTPATIENT UNIT OF THE UNIVERSITY PEDIATRIC CLINIC

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750333

Locations
Italy
University of Bari Medical School - Dept Biomedical Sciences and Human Oncology
Bari, Italy, 70124
Sponsors and Collaborators
Monica Montagnani
Investigators
Principal Investigator: Monica Montagnani, MD, PhD University of Bari Medical School
  More Information

No publications provided

Responsible Party: Monica Montagnani, Medical School Faculty Member - Professor of Pharmacology, Montagnani, Monica, M.D., Ph.D.
ClinicalTrials.gov Identifier: NCT01750333     History of Changes
Other Study ID Numbers: OBETAD-01
Study First Received: December 12, 2012
Last Updated: December 12, 2012
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013