Frequency of Metabolic Syndrome in Down Syndrome Patients

May 2, 2017 updated by: ALEJANDRO ERNESTO MACIAS HERNANDEZ, Universidad de Guanajuato

Prevalence of Metabolic Syndrome in Down Syndrome Patients

The aim of this study is to assess the frequency of metabolic syndrome in Down syndrome patients because the prevalence of diabetes mellitus and obesity is higher in individuals with Down syndrome than in the general population.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

96

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

  • Mexico
    • Guanajuato
      • Leon, Guanajuato, Mexico, 37320
        • School of Medicine, University of Guanajuato

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

7 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community sample

Description

Inclusion Criteria:

  • Clinical diagnosis of Down syndrome

Exclusion Criteria:

  • History of congenital cardiac defects requiring open-heart surgery
  • History of gastroenterologic anomalies requiring bowel resection and/or ongoing medical intervention
  • History of leukemia or other cancer
  • History of hypothyroidism requiring thyroid hormone replacement

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Case
Patients with clinical and cytogenetics diagnosis of Down syndrome, between 7 - 24 years old.
Control
Siblings of the same gender of the case, between 7-24 years old.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To asses the frequency of the metabolic syndrome among Down syndrome patients. Metabolic syndrome was defined by Adult Treatment Panel III criteria modified by Halley-Castillo.
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the insulin resistance and insulin sensitivity using the HOMA and QUICKY methods.
Time Frame: One year
One year

Collaborators and Investigators

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

Sponsor

Universidad de Guanajuato

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 (Actual)

September 1, 2009

Primary Completion (Actual)

December 21, 2009

Study Completion (Actual)

March 31, 2010

Study Registration Dates

First Submitted

March 17, 2009

First Submitted That Met QC Criteria

March 17, 2009

First Posted (Estimate)

March 18, 2009

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 249-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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