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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT01750333
Other study ID # OBETAD-01
Secondary ID
Status Unknown status
Phase N/A
First received December 12, 2012
Last updated December 12, 2012
Start date April 2012
Est. completion date March 2013

Study information

Verified date December 2012
Source Montagnani, Monica, M.D., Ph.D.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Unknown status
Enrollment 60
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender All
Age group 5 Years to 13 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy University of Bari Medical School - Dept Biomedical Sciences and Human Oncology Bari

Sponsors (1)

Lead Sponsor Collaborator
Monica Montagnani

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation between serum levels of ET-1 and Ad in lean, overweight and obese children 12 months
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