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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

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

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 hours (-10, 0, 30, 60, 90, 120, 150, 180 minutes) auc change from day 1 to day 7

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Continuous glucose monitor measures

In-Lab c-peptide area under the curve (AUC)

In-Lab glucose area under the curve (AUC)

+1 more

Secondary outcome measures

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

2009

Completed Early Phase 1

~130

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

905 Previous Clinical Trials

1,596,098 Total Patients Enrolled

Children's Hospital Los AngelesOTHER

232 Previous Clinical Trials

5,076,560 Total Patients Enrolled

Dana-Farber Cancer InstituteOTHER

1,079 Previous Clinical Trials

340,768 Total Patients Enrolled

Media Library

Metabolic Disorders Clinical Trial 2023: EX Highlights & Side Effects. Trial Name: NCT04469790 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots to join this research endeavor?

"Yes, according to clinicaltrials.gov this study has been open for recruitment since March 1st 2022 and was last edited on March 15th of the same year. The goal is to find 235 patients at a single medical facility."

Answered by AI

To whom is this research study open?

"This trial is looking to enrol 235 children aged between 7 and 11 who have affective disorder. In addition, they must be of good health with a fasting plasma glucose level below 100 mg/dL, BMI at or above the 85th percentile for their age group, and either pre-pubertal or peri-puberty."

Answered by AI

Does the study accept participants aged twenty years or older?

"This clinical trial has specific requirements to be eligible. Patients need to range from 7 to 11 years old. There are 78 studies designed for those under 18 and 329 for the elderly population above 65."

Answered by AI

How many candidates is this trial enrolling?

"Affirmative. Evidenced by the clinicaltrials.gov repository, this study is actively recruiting participants and was originally posted on March 1st 2022. The trial seeks to enlist 235 patients from a single medical facility."

Answered by AI