NCT01821300

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
257

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2013

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2017

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

January 9, 2019

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

4.6 years

First QC Date

March 27, 2013

Results QC Date

October 31, 2018

Last Update Submit

July 19, 2019

Conditions

Down SyndromeTrisomy 21

Keywords

Down syndromePhiladelphiaThe Children's Hospital of PhiladelphiaBody compositionObesityCardiovascular

Outcome Measures

Primary Outcomes (10)

  • Non-HDL Cholesterol

    Non-HDL cholesterol measured via fasting blood draw

    Study Visit 1

  • Lipid Subparticles

    Lipoprotein subclass particle analysis run on samples from fasting blood drawn Study Visit 1.

    Study Visit 1

  • Lipid Subparticles (Size)

    Lipoprotein subclass particle analysis run on samples from fasting blood drawn Study Visit 1.

    Study Visit 1

  • Insulin Resistance

    Insulin Resistance (HOMA-IR) was calculated as \[fasting insulin (uIU/mL) x fasting glycemia (mmol/L)\]/22.5

    Study Visit 1

  • Cardiometabolic Risk Biomarker Proteins

    hs-CRP, PAI-1, and IL-6 run on samples from fasting blood drawn Study Visit 1.

    Study Visit 1

  • 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

  • Visceral Fat

    Adiposity measured by Dual-energy X-ray absorptiometry

    Study Visit 1

  • Body Mass Measures

    Adiposity measured by Dual-energy X-ray absorptiometry

    Study Visit 1

  • 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

  • Pulse Wave Velocity

    Cardiac end organ injury assessed by Pulse Wave Velocity (PWV)

    Study Visit 1

Secondary Outcomes (2)

  • Health Related Quality of Life - PedsQL

    Study Visit 1

  • Health Related Quality of Life - IWQOL

    Study Visit 1

Study Arms (2)

Down syndrome

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

Control

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

Eligibility Criteria

Age10 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited from primary care and speciality clinics, Trisomy 21 events, T21 interest groups, and referrals.

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (4)

  • Magge SN, Zemel BS, Pipan ME, Gidding SS, Kelly A. Cardiometabolic Risk and Body Composition in Youth With Down Syndrome. Pediatrics. 2019 Aug;144(2):e20190137. doi: 10.1542/peds.2019-0137. Epub 2019 Jul 17.

    PMID: 31315916DERIVED

  • Kelly A, Magge SN, Walega R, Cochrane C, Pipan ME, Zemel BS, Cohen MS, Gidding SS, Townsend R. Cross-Sectional Study of Arterial Stiffness in Adolescents with Down Syndrome. J Pediatr. 2019 Sep;212:79-86.e1. doi: 10.1016/j.jpeds.2019.04.059. Epub 2019 Jun 11.

    PMID: 31201031DERIVED

  • Kelly A, Gidding SS, Walega R, Cochrane C, Clauss S, Townsend RR, Xanthopoulos M, Pipan ME, Zemel BS, Magge SN, Cohen MS. Relationships of Body Composition to Cardiac Structure and Function in Adolescents With Down Syndrome are Different than in Adolescents Without Down Syndrome. Pediatr Cardiol. 2019 Feb;40(2):421-430. doi: 10.1007/s00246-018-2014-5. Epub 2018 Nov 1.

    PMID: 30386863DERIVED

  • Xanthopoulos MS, Walega R, Xiao R, Prasad D, Pipan MM, Zemel BS, Berkowitz RI, Magge SN, Kelly A. Caregiver-Reported Quality of Life in Youth with Down Syndrome. J Pediatr. 2017 Oct;189:98-104.e1. doi: 10.1016/j.jpeds.2017.06.073. Epub 2017 Jul 24.

    PMID: 28751125DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum will be retained.

MeSH Terms

Conditions

Down SyndromeObesity

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Andrea Kelly
Organization
The Children's Hopsital of Philadelphia
kellya@email.chop.edu
215590-3174

Study Officials

  • Andrea Kelly, MD, MSCE

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2013

First Posted

April 1, 2013

Study Start

February 1, 2013

Primary Completion

August 25, 2017

Study Completion

August 25, 2017

Last Updated

July 31, 2019

Results First Posted

January 9, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)