Frequency of Metabolic Syndrome in Down Syndrome Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Universidad de Guanajuato.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Universidad de Guanajuato
ClinicalTrials.gov Identifier:
NCT00864461
First received: March 17, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the insulin resistance and insulin sensitivity using the HOMA and QUICKY methods. [ Time Frame: One year ] [ Designated as safety issue: No ]

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)
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

Ages Eligible for Study:   7 Years to 24 Years
Genders Eligible for Study:   Both
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 requirin bowel resection and/or ongoing medical intervention
  • History of leukemia or other cancer
  • History of hypothyroidism requiring thyroid hormone replacement
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00864461

Contacts
Contact: Alejandro E Macias, MD 01477 7 14 58 59 ext 401 aaeemmhh@yahoo.com

Locations
Mexico
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    aaeemmhh@yahoo.com   
Sponsors and Collaborators
Universidad de Guanajuato
  More Information

No publications provided

Responsible Party: Dr. Alejandro Ernesto Macías Hernández, School of Medicine of Leon, University of Guanajuato
ClinicalTrials.gov Identifier: NCT00864461     History of Changes
Other Study ID Numbers: 249-08
Study First Received: March 17, 2009
Last Updated: March 17, 2009
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

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

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

ClinicalTrials.gov processed this record on October 21, 2014