Study on Correlation Between Vascular ET-1 and Adiponecti... | NCT01750333

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

NCT01750333

Sponsor

Monica Montagnani

Status

Unknown status

Last Update Posted

Dec 17, 2012Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

OBESITY
Endothelial Dysfunction
Insulin Resistance

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Mar 2013Estimated

Completion Date

Mar 2013Estimated

First Submitted Date

Dec 12, 2012

First Submission Date that Met QC Criteria

Dec 12, 2012

First Posted Date

Dec 17, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2012

Last Update Posted Date

Dec 17, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Monica Montagnani, Medical School Faculty Member - Professor of Pharmacology, Montagnani, Monica, M.D., Ph.D.Sponsor-Investigator

Lead Sponsor

Monica MontagnaniINDIV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between serum levels of ET-1 and Ad in lean, overweight and obese children		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

13 Years

Standard Ages

Child

Study Population

CHILDREN ATTENDING THE OUTPATIENT UNIT OF THE UNIVERSITY PEDIATRIC CLINIC

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Monica Montagnani, MD, PhD	University of Bari Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Bari Medical School - Dept Biomedical Sciences and Human Oncology		Bari		70124	Italy

Type	Date	Date Unknown
Release	Mar 14, 2016
Reset	Apr 11, 2016

Submission Tracking

Estimated Results First Submitted Date

Mar 14, 2016

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 14, 2016			Apr 11, 2016

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Lean children
Overweight Children (OW)
Obese children (Ob)