Down Syndrome Clinical Trial
Official title:
Cardiometabolic Risk and Obesity in Adolescents With Down Syndrome
Verified date | July 2019 |
Source | Children's Hospital of Philadelphia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 257 |
Est. completion date | August 25, 2017 |
Est. primary completion date | August 25, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 10 Years to 20 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Children's National Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Philadelphia | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Non-HDL Cholesterol | Non-HDL cholesterol measured via fasting blood draw | Study Visit 1 | |
Primary | Lipid Subparticles | Lipoprotein subclass particle analysis run on samples from fasting blood drawn Study Visit 1. | Study Visit 1 | |
Primary | Lipid Subparticles (Size) | Lipoprotein subclass particle analysis run on samples from fasting blood drawn Study Visit 1. | Study Visit 1 | |
Primary | Insulin Resistance | Insulin Resistance (HOMA-IR) was calculated as [fasting insulin (uIU/mL) x fasting glycemia (mmol/L)]/22.5 | Study Visit 1 | |
Primary | Cardiometabolic Risk Biomarker Proteins | hs-CRP, PAI-1, and IL-6 run on samples from fasting blood drawn Study Visit 1. | Study Visit 1 | |
Primary | Abnormal Glucose Tolerance | Impaired fasting glucose (IFG) was defined as fasting glucose = 100 mg/dl. Impaired glucose tolerance (IGT) was defined as 2-hour glucose 140-199 mg/dl measured as part of an oral glucose tolerance test. | Study Visit 1 | |
Primary | Visceral Fat | Adiposity measured by Dual-energy X-ray absorptiometry | Study Visit 1 | |
Primary | Body Mass Measures | Adiposity measured by Dual-energy X-ray absorptiometry | Study Visit 1 | |
Primary | Left Ventricular Mass | Cardiac end organ injury assessed by echocardiography. Left Ventricular Mass (LVM) was measured by area/length method using the apical four-chamber and parasternal short-axis views. LVM was calculated as LV area × LV length × 1.05 × 5/6. | Study Visit 1 | |
Primary | Pulse Wave Velocity | Cardiac end organ injury assessed by Pulse Wave Velocity (PWV) | Study Visit 1 | |
Secondary | Health Related Quality of Life - PedsQL | Caregiver-perception of his/her child's health-related QOL was assessed with the use of the parent-proxy report of the Pediatric Quality of Life Inventory (PedsQL) Version 4.0. Sub-scale scores are converted to a 0-100 scale so that greater scores indicate better QOL. Scale scores are computed as the sum of the items divided by the number of items answered (this accounts for missing data). If more than 50% of the items in the scale are missing, the scale score is not computed. The Physical Health Summary Score (8 items) is the same as the Physical Functioning Scale. To create the Psychosocial Health Summary Score (15 items), the mean is computed as the sum of the items divided by the number of items answered in the Emotional, Social, and School Functioning Scales. | Study Visit 1 | |
Secondary | Health Related Quality of Life - IWQOL | Parent perception of the effects of weight on his/her child's QOL was assessed with a caregiver-proxy version of the Impact of Weight on Quality of Life - Kids (IWQOL-Kids) questionnaire. The IWQOL-Kids is a validated, 27-item, self-report measure of weight-related QOL for youth ages 11-19 years. It yields 4 subscales (Physical Comfort, Body Esteem, Social Life, and Family Relations) and a Total score, which have strong psychometric properties, discriminate among weight status groups, and are responsive to weight change. Scaled scores are standardized and range from 0 to 100, with greater scores representing better weight-related QOL. | Study Visit 1 |
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