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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pediatric Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014