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Sedentary Interruptions + Exercise for Reducing Type 2 Diabetes Risk in Children

N/A
Recruiting
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pre- or peri-puberty
Age 7-11 years-old
Must not have
Significant cardiac or pulmonary disease likely to or resulting in hypoxia or decreased perfusion
Evidence of impaired glucose tolerance or T2DM, presence of other endocrinologic disorders leading to obesity (e.g., Cushing Syndrome)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 hours (-10, 0, 30, 60, 90, 120, 150, 180 minutes) auc change from day 1 to day 7
Awards & highlights

Summary

This trial will test the effects of multi-day interruptions in sedentary behavior vs. single bouts of sustained exercise on metabolic, cognitive, and affective responses in children with overweight and obesity who are at risk for type 2 diabetes.

Who is the study for?
This trial is for children aged 7-11 who are overweight or obese, with a BMI in the top 15% for their age. They must have normal fasting blood sugar levels and be generally healthy without any significant heart or lung diseases, endocrine disorders like Cushing Syndrome, or treatments affecting body weight.
What is being tested?
The study compares two ways to reduce sedentary behavior's negative effects on kids at risk for type 2 diabetes: breaking up sitting time over several days versus single sessions of exercise. It measures how these methods affect metabolism, mood, cognitive function, and heart rate variability using continuous glucose monitoring.
What are the potential side effects?
Since this trial involves basic physical activity interventions such as walking breaks or exercise sessions rather than medication, side effects may include typical exercise-related discomforts like muscle soreness but no severe drug-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not gone through puberty yet.
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I am between 7 and 11 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have serious heart or lung conditions that affect my breathing or blood flow.
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I have diabetes or a condition like Cushing Syndrome that causes obesity.
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I have used anti-psychotic drugs that may affect my metabolism.
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I am being treated for early puberty with hormone therapy.
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I am on medication for high blood pressure or cholesterol.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 hours (-10, 0, 30, 60, 90, 120, 150, 180 minutes) auc change from day 1 to day 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 hours (-10, 0, 30, 60, 90, 120, 150, 180 minutes) auc change from day 1 to day 7 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Continuous glucose monitor measures
In-Lab c-peptide area under the curve (AUC)
In-Lab glucose area under the curve (AUC)
+1 more
Secondary study objectives
Cardiac autonomic nervous system measures
Cognitive function measures
Positive and Negative Affect Scale for Children
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: SIT+WALKExperimental Treatment1 Intervention
Interrupt sitting with 3-minutes of moderate-intensity walking every 30 minutes for 3 hours
Group II: EXExperimental Treatment1 Intervention
Perform 18 consecutive minutes of moderate-intensity walking, then sit for the remaining time
Group III: SITActive Control1 Intervention
Continuous sitting for 3 hours
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EX
2009
Completed Early Phase 1
~130

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
936 Previous Clinical Trials
1,613,293 Total Patients Enrolled
Children's Hospital Los AngelesOTHER
244 Previous Clinical Trials
5,072,878 Total Patients Enrolled
Dana-Farber Cancer InstituteOTHER
1,100 Previous Clinical Trials
352,909 Total Patients Enrolled

Media Library

Metabolic Disorders Clinical Trial 2023: EX Highlights & Side Effects. Trial Name: NCT04469790 — N/A
~80 spots leftby Jul 2026
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