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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01231152
Other study ID # OB10
Secondary ID
Status Recruiting
Phase N/A
First received October 29, 2010
Last updated May 24, 2012
Start date September 2010
Est. completion date December 2012

Study information

Verified date May 2012
Source University of Athens
Contact n/a
Is FDA regulated No
Health authority Greece: Ethics Committee
Study type Observational

Clinical Trial Summary

The aim of the study is to investigate the association of obesity with arterial blood pressure, atherosclerosis, target organ damage (heart, arteries, kidney) and insulin resistance in children and young adolescents.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 18 Years
Eligibility Inclusion Criteria:

- Overweight (85th<BMI<95th percentile) and obese (BMI>=95th percentile) children and adolescents

- No medication treatment (apart from bronchodilators, T4 in euthyroid children)

- No severe mental problem

- Parents' and patients' signed consent

Exclusion Criteria:

- Severe chronic or acute cardiac disease or other severe chronic or acute disease

- Any acute inflammation

- Familial dyslipidemia

- Clinical hypothyroidism or other endocrinopathy

- Poor compliance.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Greece Hypertension Center, Third Department of Medicine, University of Athens Athens

Sponsors (1)

Lead Sponsor Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood Pressure levels, Target organ damage (Left Ventricular Hypertrophy, IMT, pulse wave velocity, microalbuminuria), Insulin Resistance 3 weeks No
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