Pediatric Metabolic Syndrome Study | NCT03570840

Studies
Pediatric Metabolic Syndrome Study

NCT03570840

Sponsor

Medical University of South Carolina

Status

Completed

Last Update Posted

Jun 28, 2018Actual

Enrollment

477Actual

Phase

Not provided

Conditions

Metabolic Syndrome
Overweight and Obesity
Cardiovascular Risk Factor

Interventions

Not provided

Countries

United States

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
0863	Other Identifier	CTRC

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Jun 10, 2015Actual

Completion Date

Apr 5, 2017Actual

First Submitted Date

May 9, 2011

First Submission Date that Met QC Criteria

Jun 25, 2018

First Posted Date

Jun 27, 2018Actual

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

Jun 26, 2018

Last Update Posted Date

Jun 28, 2018Actual

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 Pediatric Metabolic Syndrome Study is an observational study being conducted at the Medical University of South Carolina to investigate cardiometabolic risk parameters in obese subjects ages 4 to 21. A detailed assessment is performed on eligible subjects including fasting labwork, anthropometrics, nutrition analysis, body composition testing, echocardiography, and carotid IMT measurements.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

477Actual

Label	Type	Description	Intervention Names
obese children and adolescents

Measure	Description	Time Frame
fasting insulin		baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 4 to 21 years history of obesity (BMI at or over the 95th% for age/gender)

Exclusion Criteria:

age below 4 or above 21 years no history of obesity current pregnancy current chronic oral steroid use current insulin use

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

obese 4 to 21 yo subjects

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Melissa H Henshaw, MD	Medical University of South Carolina	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MUSC		Charleston	South Carolina	29425	United States

Condition Browse Module

MeSH Terms

ID	Term
D024821	Metabolic Syndrome
D050177	Overweight
D009765	Obesity

Ancestor Terms

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided