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Frequency of Metabolic Syndrome in Down Syndrome Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by Universidad de Guanajuato.
Recruitment status was:  Not yet recruiting
Information provided by:
Universidad de Guanajuato Identifier:
First received: March 17, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
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.

Metabolic Syndrome X
Down Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional

Resource links provided by NLM:

Further study details as provided by Universidad de Guanajuato:

Primary Outcome Measures:
  • To asses the frequency of the metabolic syndrome among Down syndrome patients. Metabolic syndrome was defined by Adult Tratment 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

Estimated Enrollment: 96
Study Start Date: May 2009
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Patients with clinical and cytogenetics diagnosis of Down syndrome, between 7 - 24 years old.
Siblings of the same gender of the case, between 7-24 years old.


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

Inclusion Criteria:

  • Clinical diagnosis of Down syndrome

Exclusion Criteria:

  • History of congenital cardiac defects requiring open-heart surgery
  • History of gastroenterologic anomalies requirin bowel resection and/or ongoing medical intervention
  • History of leukemia or other cancer
  • History of hypothyroidism requiring thyroid hormone replacement
  Contacts and Locations
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Please refer to this study by its identifier: NCT00864461

Contact: Alejandro E Macias, MD 01477 7 14 58 59 ext 401

School of Medicine, University of Guanajuato Not yet recruiting
Leon, Guanajuato, Mexico, 37320
Contact: Alejandro E Macías, MD    01477 7 14 58 59 ext 401   
Sponsors and Collaborators
Universidad de Guanajuato
  More Information

Responsible Party: Dr. Alejandro Ernesto Macías Hernández, School of Medicine of Leon, University of Guanajuato Identifier: NCT00864461     History of Changes
Other Study ID Numbers: 249-08
Study First Received: March 17, 2009
Last Updated: March 17, 2009

Keywords provided by Universidad de Guanajuato:
Down syndrome
Metabolis syndrome X
Insulin resistance

Additional relevant MeSH terms:
Metabolic Syndrome X
Down Syndrome
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn processed this record on April 26, 2017