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Frequency of Metabolic Syndrome in Down Syndrome Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00864461
First Posted: March 18, 2009
Last Update Posted: May 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ALEJANDRO ERNESTO MACIAS HERNANDEZ, Universidad de Guanajuato
  Purpose
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.

Condition
Metabolic Syndrome X Down Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Prevalence of Metabolic Syndrome in Down Syndrome Patients

Resource links provided by NLM:


Further study details as provided by ALEJANDRO ERNESTO MACIAS HERNANDEZ, Universidad de Guanajuato:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Evaluate the insulin resistance and insulin sensitivity using the HOMA and QUICKY methods. [ Time Frame: One year ]

Biospecimen Retention:   Samples With DNA
Whole blood

Enrollment: 96
Actual Study Start Date: September 1, 2009
Study Completion Date: March 31, 2010
Primary Completion Date: December 21, 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00864461


Locations
Mexico
School of Medicine, University of Guanajuato
Leon, Guanajuato, Mexico, 37320
Sponsors and Collaborators
Universidad de Guanajuato
  More Information

Responsible Party: ALEJANDRO ERNESTO MACIAS HERNANDEZ, MD, Universidad de Guanajuato
ClinicalTrials.gov Identifier: NCT00864461     History of Changes
Other Study ID Numbers: 249-08
First Submitted: March 17, 2009
First Posted: March 18, 2009
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by ALEJANDRO ERNESTO MACIAS HERNANDEZ, Universidad de Guanajuato:
Down syndrome
Metabolic syndrome X
Insulin resistance

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Down Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn