Down Syndrome Metabolic Health Study

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

257 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2017-08-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Down Syndrome Trisomy 21

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Down syndrome

No intervention occurred as this was a cross sectional observational study.

No interventions assigned to this group

Control

No intervention occurred as this was a cross sectional observational study.

No interventions assigned to this group

Eligibility Criteria

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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

* 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)

Minimum Eligible Age

10 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes