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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Monica Montagnani, Montagnani, Monica, M.D., Ph.D..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01750333
First Posted: December 17, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Monica Montagnani, Montagnani, Monica, M.D., Ph.D.
  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

Further study details as provided by Monica Montagnani, 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: December 12, 2012
First Posted: December 17, 2012
Last Update Posted: October 12, 2017
Last Verified: December 2012

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