An observational study in Autism Spectrum Disorder (ASD), Cardiometabolic Health Indicators and Cardiometabolic Risk Factors, sponsored by University of Virginia. Recruiting at 1 site in United States. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by University of Virginia · Observational
Among 772 studies in Autism Spectrum Disorder with a site in United States — 165 open to participants now, 204 under way, 9 of them phase 3. Autism Spectrum Disorder · United States.
Among the 772 studies in Autism Spectrum Disorder with a site in United States, this one is the 49th largest by planned enrollment of the 113 observational ones that give a count, is one of 46 that started in 2026, is one of 113 observational ones, reaches primary completion later than 60 of the 202 other live ones, and was the 765th registered.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
Browse Autism Spectrum Disorder studies →165 of the 772 studies in Autism Spectrum Disorder with a site in United States are open now. Recruiting first, the newest first:
Massachusetts General Hospital · Sites in United States
Schweitzer Engineering Laboratories · Sites in United States
Children's Hospital Medical Center, Cincinnati · Sites in United States
Bristol-Myers Squibb · Sites in United States, Australia, Canada and 1 more country
Bristol-Myers Squibb · Sites in United States, France, Germany and 7 more countries
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 349 Autism Spectrum Disorder studies recruiting now, 48 (14%) set no upper age limit and 294 (84%) stop at 75 or younger; 297 take children under 18; 92 take healthy volunteers.
This study: 6 Years to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
772 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 52 · Phase 2 117 · Phase 3 33 · Phase 4 16
First in 2004; this study’s year is marked. 46 started in 2026.
This study's planned enrollment of 200 is above the median of 102 across 320 observational studies indexed under Autism Spectrum Disorder.
Median enrollment 50 across the 658 interventional studies, 131 across the 113 observational. Of the 521 that completed or were terminated, 174 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
89 of 772 have an industry lead sponsor. The 10 most frequent:
University of Virginia is the lead sponsor of 675 studies on the registry; 138 are open to participants now.
Of its 61 completed or terminated interventional studies of FDA-regulated products, 42 (69%) have results posted.
University of Virginia has 1 study filed under Autism Spectrum Disorder — fewer than ten, so there is no comparison to draw.
68 of the studies in Autism Spectrum Disorder with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06706674Phase 3Intra-Cellular Therapies, Inc.Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients | 2027-06-21 |
| NCT06690398Phase 3Intra-Cellular Therapies, Inc.Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients | 2027-06-21 |
| NCT07670000Natalia PoluektovaMental And Speech Developmental Delay Autism Spectrum-Type Behavioral Disorder | 2026-11 |
| NCT04242355Yale UniversityTranscranial Magnetic Stimulation on Neural and Behavioral Facets of Social Cognition in Autism Spectrum Disorder | 2026-12 |
| NCT06059352Loma Linda UniversitySleep and Central Auditory Processing Disorder in Autism Spectrum Disorder | 2026-12 |
Among the 772 studies in Autism Spectrum Disorder with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
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:
Pediatric obesity and cardiometabolic health problems are major public health concerns. Children with obesity may have a higher risk of developing conditions such as insulin resistance, prediabetes, abnormal cholesterol levels, high blood pressure, and cardiovascular disease later in life. In clinical practice, body mass index (BMI), body measurements, and blood tests are commonly used to assess health risk. Although these measures provide important information, they do not fully describe how well a child's heart, lungs, and muscles work during physical activity. Cardiorespiratory fitness (CRF) provides information about the body's ability to use oxygen during exercise and reflects the combined function of several body systems. Higher levels of CRF have been associated with better cardiometabolic health and a lower risk of future disease.
Fitness testing is not routinely used in pediatric clinical settings. Traditional CRF testing may require specialized equipment and exercise at maximal intensity, which can be difficult for some children and may not be practical during a routine clinic visit. Simple, clinically feasible tests, such as the 3-minute step test (3MST), may provide a practical way to assess cardiorespiratory fitness without requiring expensive equipment or maximal exercise. Handgrip strength (HGS) testing is another simple measure that can provide information about muscular fitness and physical function. These tests may be especially useful in pediatric populations because they can be completed in a relatively short period of time and require limited equipment.
Research has shown that cardiorespiratory and muscular fitness are related to several measures of cardiometabolic health, including body composition, blood glucose, cholesterol levels, and other risk factors for metabolic and cardiovascular disease. However, less is known about how these fitness measures relate to cardiometabolic health in children with obesity who are evaluated in routine clinical care, particularly among children with autism spectrum disorder (ASD). Children with ASD may have differences in physical activity, motor skills, and participation in exercise that could affect fitness and cardiometabolic health.
This study will examine cardiorespiratory and muscular fitness in children with obesity, with and without ASD. The study will evaluate whether differences in fitness are associated with body measurements, body composition, and markers of cardiometabolic health, including blood glucose and lipid measures. The findings may improve understanding of the relationship between physical fitness and cardiometabolic health in children with obesity and may help determine whether simple fitness assessments can provide useful information during pediatric clinical evaluations. In the future, these assessments may support more individualized exercise recommendations and contribute to strategies for improving long-term cardiometabolic health in children.
Obese Pediatrics with or without Autism Spectrum Disorder
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Obese and Prediabetic
Obese and Pediatric
Cardiorespiratory Fitness
Cardiorespiratory Fitness as determined by 3-minute step test results, which includes post 1-minute heartrate per Kasch Pulse Recovery Test
Time frame: January 1 - December 31 2026
Handgrip Strength
As defined by handgrip test using hand dynamometer in kilograms
Time frame: January 1 - December 31 2026
Aerobic Capacity
Estimation of VO2 max per ml/kg/min derived from results of 3-minute step test
Time frame: January 1, 2026 to December 31, 2026
Prediabetes
As defined by HbA1c levels
Time frame: January 1 - December 31 2026
Cardiometabolic Risk
As defined by blood pressure
Time frame: January 1 - December 31 2026
Pediatric Obesity
As defined by BMI percentile \> 95th percentile
Time frame: January 1 - December 31 2026
LDL
As determined by level of low-density lipoprotein
Time frame: January 1 - December 31 2026
HDL
As defined by high-density lipoprotein levels
Time frame: January 1 - December 31 2026
Dyslipidemia
As defined by levels of Triglycerides
Time frame: January 1 - December 31 2026
Cholesterolemia
As defined by level of total cholesterol
Time frame: January 1 - December 31 2026
RHR
As defined by resting heart rate in beats per minute
Time frame: January 1 - December 31 2026
Started Aug 2026 (actual). Primary completion is estimated for Dec 2026, 4 months after the start.
How these figures are worked out, and which studies are left out of them.
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