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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2012 by Montagnani, Monica, M.D., Ph.D..
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Monica Montagnani, Montagnani, Monica, M.D., Ph.D. Identifier:
First received: December 12, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
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

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

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)
Lean children
Overweight Children (OW)
Obese children (Ob)


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

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
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Please refer to this study by its identifier: NCT01750333

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

Responsible Party: Monica Montagnani, Medical School Faculty Member - Professor of Pharmacology, Montagnani, Monica, M.D., Ph.D. 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
Nutrition Disorders
Body Weight
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases processed this record on October 21, 2016