N/A
N=257
Down Syndrome Metabolic Health Study
Down Syndrome · Trisomy 21
Bottom Line
View on ClinicalTrials.gov: NCT01821300 ↗Enrolled (actual)
257
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Non-HDL Cholesterol — 128; 107 mg/dl
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Non-HDL Cholesterol |
128; 107 | — |
| PRIMARY Lipid Subparticles |
9.8; 11.7; 3.9; 2.4; 518; 420 | — |
| PRIMARY Lipid Subparticles (Size) |
9.6; 9.6; 49.2; 47.1; 20.7; 20.7 | — |
| PRIMARY Insulin Resistance |
1.8; 1.95 | — |
| PRIMARY Cardiometabolic Risk Biomarker Proteins |
2.3; 1.5; 0.0204; 0.0254; 2.5; 1.0 | — |
| PRIMARY Abnormal Glucose Tolerance |
12; 3; 10; 3 | — |
| PRIMARY Visceral Fat |
54.5; 55.9 | — |
| PRIMARY Body Mass Measures |
18607.5; 22372.1; 34927.16; 44108.3 | — |
| PRIMARY Left Ventricular Mass |
68.3; 64 | — |
| PRIMARY Pulse Wave Velocity |
5; 4.9 | — |
| SECONDARY Health Related Quality of Life - PedsQL |
68.3; 73.2; 78.9; 89.7; 73.3; 76.0 | — |
| SECONDARY Health Related Quality of Life - IWQOL |
83.3; 97.1; 86.0; 98.2; 91.4; 98.0 | — |
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).
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01821300). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.