Down Syndrome Metabolic Health Study

Completed

Conditions studied: Down Syndrome, Trisomy 21

In brief

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). We hypothesize that DS is associated with worse cardiometabolic risk factors for a given body mass index compared to controls. This difference arises at least in part, from increased fat tissue.

Key facts

Study ID

NCT01821300

Run by

Children's Hospital of Philadelphia

People needed

257

Starts

2013-02-01

Expected to finish

2017-08-25

Last updated by the study team

2019-07-31

Who can join

Age: 10 and older, up to 20. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

Where it is running

• Children's National Medical Center — Washington D.C., District of Columbia, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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