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Meal Timing for Type 2 Diabetes (TimeLEAD Trial)

N/A
Recruiting
Led By Alaina Vidmar, MD
Research Sponsored by Children's Hospital Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of T2D based on the ADA diagnostic guidelines
Age 12-21 years
Must not have
Previous diagnosis of Prader-Willi Syndrome, brain tumor, or hypothalamic obesity
Previous diagnosis or subthreshold symptoms of an eating disorder (anorexia nervosa, bulimia nervosa, binge-eating disorder)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at week 0,4, 12
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effects of time-restricted eating (TLE), where participants eat all their meals within an 8-hour window, on glycemic control and body composition in adolescents with type 2 diabetes (T2D). The goal is to determine whether TLE is a beneficial as part of the medical regimen early in diagnosis in adolescents living with T2D.

Who is the study for?
Adolescents aged 12-21 with Type 2 Diabetes (T2D) and a Hemoglobin A1c below 9% can join this trial. They must be at least in Tanner stage III of puberty, able to follow the study's schedule, and not have any eating disorders or conditions like Prader-Willi Syndrome.
What is being tested?
The trial is testing Time Limited Eating (TLE), where participants eat within an 8-hour window and fast for 16 hours daily, against a control group with a regular eating period over 12 hours. The goal is to see if TLE improves blood sugar control and body composition in adolescents with T2D.
What are the potential side effects?
Potential side effects are not detailed but may include changes in hunger levels, mood swings due to fasting periods, potential impact on growth or development due to dietary restrictions, and possible discomfort from wearing Continuous Glucose Monitors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Type 2 Diabetes.
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I am between 12 and 21 years old.
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I have reached mid to late puberty.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with Prader-Willi Syndrome, a brain tumor, or hypothalamic obesity.
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I have had an eating disorder or symptoms of one.
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I am planning to use medication for obesity or diabetes.
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I have had or am planning to have weight loss surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at week 0,4, 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at week 0,4, 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Hemoglobin A1c
Change in insulinogenic index
Change in percent time in range
+1 more
Secondary study objectives
ASA 24 Dietary Recall
Change in BMI in excess of the 95th percentile (%BMIp95)
International Physical Activity Questionnaire (IPAQ)
+2 more
Other study objectives
Adult eating behavior Questionnaire
Binge eating disorder screen

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Time Limited EatingExperimental Treatment3 Interventions
Time Limited Eating: 8-hour eating period (16 hours of daily fasting).
Group II: Control: 12 hour eating periodExperimental Treatment3 Interventions
Control: Habitual daily eating period (no meal time restrictions)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Time Limited Eating
2022
N/A
~70
Control
2011
Completed Phase 4
~15780
Continuous Glucose Monitor
2021
Completed Early Phase 1
~860

Find a Location

Who is running the clinical trial?

Children's Hospital Los AngelesLead Sponsor
248 Previous Clinical Trials
5,074,524 Total Patients Enrolled
Alaina Vidmar, MDPrincipal InvestigatorChildren's Hospital Los Angeles
3 Previous Clinical Trials
192 Total Patients Enrolled

Media Library

Control Clinical Trial Eligibility Overview. Trial Name: NCT04536480 — N/A
Type 2 Diabetes Research Study Groups: Time Limited Eating, Control: 12 hour eating period
Type 2 Diabetes Clinical Trial 2023: Control Highlights & Side Effects. Trial Name: NCT04536480 — N/A
Control 2023 Treatment Timeline for Medical Study. Trial Name: NCT04536480 — N/A
~56 spots leftby Dec 2026
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