Status:
COMPLETED
Down Syndrome Metabolic Health Study
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Down Syndrome
Trisomy 21
Eligibility:
All Genders
10-20 years
Brief Summary
The purpose of this research study is to determine which measures best capture cardiovascular disease (CVD) risk and type 2 diabetes (T2DM) risk in children and adolescents with Down syndrome (DS). W...
Detailed Description
DS affects 1 per 800 births and is one of the most common causes of developmental disability in the US. Life expectancy for Down syndrome has increased significantly: estimated median survival in the ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Both groups: Ages 10 - 20
- Both groups: Parental/guardian permission (informed consent) and if appropriate, child assent.
- Down syndrome group only: diagnosis of Down syndrome
- Exclusion Criteria (both groups):
- Major organ system illness (such as leukemia), except for type 2 Diabetes
- Cyanotic congenital heart disease and/or pulmonary hypertension
- Medically unstable congenital heart disease
- Pregnancy
- Genetic syndrome known to affect glucose tolerance
- Familial hypercholesterolemia
- Currently treated with medications known to affect insulin sensitivity (other than diabetes agents in participants with type 2 diabetes)
Exclusion
Key Trial Info
Start Date :
February 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 25 2017
Estimated Enrollment :
257 Patients enrolled
Trial Details
Trial ID
NCT01821300
Start Date
February 1 2013
End Date
August 25 2017
Last Update
July 31 2019
Active Locations (2)
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1
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
2
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104