The Impact of Obesity on Children and Adolescents.

Obesity Clinical Trial

Official title:

The Relation of Obesity With Metabolic Disorders, Inflammation Markers and Arterial Blood Pressure With Preclinical Target-organ Damage in Children and Young Adolescents.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01231152
• Other study ID #: OB10
• 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

• Cardiovascular Risk Factors
• Obesity

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