Pediatric Metabolic Syndrome Study (PMSS)

June 26, 2018 updated by: Medical University of South Carolina
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

477

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MUSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

obese 4 to 21 yo subjects

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
obese children and adolescents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fasting insulin
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Investigators

  • Principal Investigator: Melissa H Henshaw, MD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

June 10, 2015

Study Completion (Actual)

April 5, 2017

Study Registration Dates

First Submitted

May 9, 2011

First Submitted That Met QC Criteria

June 25, 2018

First Posted (Actual)

June 27, 2018

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19375
  • 0863 (Other Identifier: CTRC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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