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Down Syndrome Metabolic Health Study

This study is currently recruiting participants.
Verified August 2017 by Children's Hospital of Philadelphia
Sponsor:
ClinicalTrials.gov Identifier:
NCT01821300
First Posted: April 1, 2013
Last Update Posted: August 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
March 27, 2013
April 1, 2013
August 10, 2017
February 2013
August 2017   (Final data collection date for primary outcome measure)
Cardiometabolic risk factors [ Time Frame: day of visit ]
Non-HDL cholesterol, lipoprotein subclass particles, blood pressure, insulin resistance, inflammatory markers, and adipokines will be measured by blood test. Glucose tolerance will be measured by an Oral Glucose Tolerance Test in overweight subjects only. Adiposity will be measured by Dual-energy X-ray absorptiometry and anthropometric measurements. Cardiac end organ injury will be assessed by pulse wave velocity and echocardiography.
Same as current
Complete list of historical versions of study NCT01821300 on ClinicalTrials.gov Archive Site
Psychosocial risk factors [ Time Frame: date of visit & 2 weeks following visit ]
Lifestyle (diet and physical activity)will be assessed via questionnaires on the date of visit. Participants will be asked to wear a physical activity armband at home for the 7 days following the visit, and to speak to a research nutritionist on the phone 3 times in the 2 weeks following the visit. Questionnaires will be done with participants and parents on the day of the visit to determine body image and quality of life.
Same as current
Not Provided
Not Provided
 
Down Syndrome Metabolic Health Study
Cardiometabolic Risk and Obesity in Adolescents With Down Syndrome

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.

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 US in 1997 was 49 years. DS is associated with an increased risk for obesity, with an estimated prevalence of 47-48% in adults and 30-50% in children with DS. Adolescents with DS are more likely to have increased adiposity compared to unaffected peers and may be at increased risk for obesity-related co-morbidities, such as type 2 diabetes and cardiovascular disease. How one defines obesity in DS is not clear. Individuals with DS have short stature and possibly increased adiposity, and the body mass index (BMI) used to define obesity for otherwise healthy populations may not accurately depict body fatness or capture cardiometabolic risk in DS.

Congenital heart disease (CHD) affects approximately 50% of individuals with DS; the National Institutes of Health Heart Lung and Blood Institute (NHLBI) Working Group on Obesity and Other Cardiovascular Risk Factors in Congenital Heart Disease highlighted the high prevalence of obesity in the setting of CHD, and called for studies to identify obesity measures that are more sensitive than BMI as well as studies of CVD risk prevention. Unfortunately, clinicians caring for obese adolescents with DS with or without CHD have little scientific evidence upon which to base guidance regarding cardiometabolic risk (CMR): data regarding CVD risk and prevalence of pre-diabetes and T2DM in obese adolescents with DS are lacking.

The measure of body fatness which best predicts CMR in DS is not known. We plan to compare BMI and other measures of body fatness in healthy controls and adolescents with DS to determine which measures best capture CVD and/or T2DM risk. These data will equip medical providers with the tools to better assess risk, initiate prevention measures, and guide screening in adolescents with DS.

Observational
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:
Blood serum will be retained.
Non-Probability Sample
Participants will be recruited from primary care and speciality clinics, Trisomy 21 events, T21 interest groups, and referrals.
  • Down Syndrome
  • Trisomy 21
Not Provided
  • Down syndrome
    Our goal is to enroll 150 subjects with Down syndrome, and to compare their data to our control group.
  • Control
    Our goal is to enroll 100 typically developing controls, who are matched to the Down syndrome group by age, sex, race, ethnicity, and BMI-z score.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
August 2017
August 2017   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
10 Years to 20 Years   (Child, Adult)
Yes
Contact: Divya Prasad, MPH 267-426-2778 prasadd@email.chop.edu
Contact: Amber Lauff, BS 267-426-0299 lauffa@email.chop.edu
United States
 
 
NCT01821300
12-009233
1R01HD071981-01A1 ( U.S. NIH Grant/Contract )
No
Not Provided
Plan to Share IPD: No
Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
  • National Institutes of Health (NIH)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Andrea Kelly, MD, MSCE Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
August 2017