This Study Will Evaluate Cardiorespiratory and Muscular Fitness to Examine Associations With Anthropometric Characteristics and Other Indicators of Cardiometabolic Risk Among Patients With or Without Autism Spectrum Disorder

NCT07804680 | Recruiting

• 1 other identifier: 303916
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate cardiorespiratory and muscular fitness in children with obesity, with and without autism spectrum disorder (ASD), and examine how fitness relates to body measurements, body composition, and cardiometabolic health. The main questions it aims to answer are:

• Do children with and without ASD differ in cardiorespiratory fitness and handgrip strength?
• Are fitness levels related to body composition and measures of cardiometabolic health? Researchers will compare children with ASD to children without ASD to see if there are differences in fitness, body composition, and cardiometabolic health. Participants will have information from their medical records reviewed, including:
• Cardiorespiratory fitness and handgrip strength test results
• Height, weight, BMI, and body composition measurements
• Blood test results, including HbA1c and cholesterol levels
• Age, sex, and other demographic information

Conditions

Autism Spectrum Disorder (ASD); Cardiometabolic Health Indicators; Cardiometabolic Risk Factors; Metabolic Syndrome; Prediabetes

Keywords

Cardiorespiratory Fitness; Metabolic Syndrome; Cardiometabolic Risk Factors; Prediabetes; Pediatrics; Austism Spectrum Disorder; Cardiometabolic Health Indicators; Fitness Testing; Handgrip Strength; Muscular Fitness

Outcome Measures

Primary Outcomes (3)

• Cardiorespiratory Fitness

  Cardiorespiratory Fitness as determined by 3-minute step test results, which includes post 1-minute heartrate per Kasch Pulse Recovery Test

  January 1 - December 31 2026

• Handgrip Strength

  As defined by handgrip test using hand dynamometer in kilograms

  January 1 - December 31 2026

• Aerobic Capacity

  Estimation of VO2 max per ml/kg/min derived from results of 3-minute step test

  January 1, 2026 to December 31, 2026

Secondary Outcomes (8)

• Prediabetes

  January 1 - December 31 2026

• Cardiometabolic Risk

  January 1 - December 31 2026

• Pediatric Obesity

  January 1 - December 31 2026

• LDL

  January 1 - December 31 2026

• HDL

  January 1 - December 31 2026

Study Arms (2)

Pediatrics with Autism Spectrum Disorder

Obese and Prediabetic

Pediatrics without Autism Spectrum Disorder

Obese and Pediatric

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Obese Pediatrics with or without Autism Spectrum Disorder

You may qualify if:

• Pediatric patients 6-18 years of age who received care at the Pediatric Endocrinology Diabetes Prevention and Fitness Clinic between January 1 and December 31, 2026.
• BMI ≥95th percentile for age and sex, consistent with the definition of pediatric obesity.
• Documented results from cardiorespiratory fitness testing and/or handgrip strength testing.
• Documented HbA1c value, when available.
• Sufficient medical record information to determine ASD status and the primary study outcomes.

You may not qualify if:

• Age \<6 or \>18 years at the time of clinical assessment.
• BMI \<95th percentile for age and sex.
• Absence of documented cardiorespiratory fitness or handgrip strength testing.
• Insufficient medical record information to determine ASD status or primary study outcomes.
• Duplicate or unusable medical records.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

UVA Health

Charlottesville, Virginia, 22903, United States

RECRUITING

Related Publications (45)

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MeSH Terms

Conditions

Autism Spectrum Disorder; Metabolic Syndrome; Prediabetic State

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

Aaron Meadows, MMed

CONTACT

434-924-0395; fzj8tx@uvahealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Exercise Physiologist

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: September 4, 2026
• Study Start: August 5, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: September 4, 2026

Record last verified: 2026-08

Locations

US (1)