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NCT00864461 Clinical Trial

Frequency of Metabolic Syndrome in Down Syndrome Patients

Down Syndrome Clinical Trial

Official title:
Prevalence of Metabolic Syndrome in Down Syndrome Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00864461
Other study ID # 249-08
Secondary ID
Status Completed
Phase N/A
First received March 17, 2009
Last updated May 2, 2017
Start date September 1, 2009
Est. completion date March 31, 2010

Study information
Verified date May 2017
Source Universidad de Guanajuato
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 96
Est. completion date March 31, 2010
Est. primary completion date December 21, 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 24 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Mexico School of Medicine, University of Guanajuato Leon Guanajuato

Sponsors (1)
Lead Sponsor Collaborator
Universidad de Guanajuato

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. One year
Secondary Evaluate the insulin resistance and insulin sensitivity using the HOMA and QUICKY methods. One year
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