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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at week 0,4, 12

Awards & highlights

TimeLEAD Trial 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.Check my eligibility

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.See study design

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.

TimeLEAD Trial 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.

TimeLEAD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at week 0,4, 12

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

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

Primary outcome measures

Change in Hemoglobin A1c

Change in insulinogenic index

Change in percent time in range

+1 more

Secondary outcome measures

ASA 24 Dietary Recall

Change in BMI in excess of the 95th percentile (%BMIp95)

International Physical Activity Questionnaire (IPAQ)

+2 more

Other outcome measures

Adult eating behavior Questionnaire

Binge eating disorder screen

TimeLEAD 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Los AngelesLead Sponsor

232 Previous Clinical Trials

5,076,640 Total Patients Enrolled

Alaina Vidmar, MDPrincipal InvestigatorChildren's Hospital Los Angeles

3 Previous Clinical Trials

185 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

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 enrollments for the clinical trial at this time?

"As reported on clinicaltrials.gov, this experiment is not currently enrolling participants. First posted in January 1st 2023 and last updated on November 15th 2022, it isn't seeking patients presently; however, there are a plethora of other studies looking for volunteers at the moment."

Answered by AI

What is the proposed outcome of this clinical exploration?

"The primary outcome variable to be monitored over Week 12 compared to baseline is the Change in percent time in range. Additionally, secondary objectives include determining sleep quality and quantity with the Pittsburg Sleep Quality Index (PSI), assessing circadian rhythm regulation with the Munich Chronotype Questionnaire for children and adolescents (MTCQ), as well as collecting dietary information via Nutrient Data System Recall 24 Hour Dietary Recall (NDSR)."

Answered by AI

Would I be eligible to join this experimental investigation?

"This research endeavour is accepting 100 adolescents aged between 14 and 21 years that are living with Type 2 diabetes mellitus. Criteria for admittance includes: (1) attaining Tanner stage III or higher; (2) meeting the American Diabetes Association's diagnostic criteria; (3) having an HbA1c level lower than 9% when on Metformin monotherapy, based upon ADA and International Society for Adolescent and Pediatric Diabetes guidelines; (4) willingness to adhere to assessment protocols, visit schedules, fasting periods, etc. Those who fit into any of the following categories will be ineligible from participating in this trial."

Answered by AI

Could those 40 or older meet the criteria for this experiment?

"The set parameters of this clinical trial stipulate that the minimum age for enrolment is 14 whereas the upper limit stands at 21."

Answered by AI

Who else is applying?

What site did they apply to?

Children's Hospital of Los Angeles

What portion of applicants met pre-screening criteria?

Did not meet criteria

Why did patients apply to this trial?

I am applying for my daughter. She turns 12 this year and is overweight. 5'4 and 176 pounds. Would be great to enroll her to help her lose weight. Thank you!

PatientReceived 2+ prior treatments

Recent research and studies

clinicaltrials.govStudy

Impact of Meal Timing on Glycemic Profiles in Adolescents With Type 2 Diabetes

Alaina P. Vidmar, MD 2023. "Impact of Meal Timing on Glycemic Profiles in Adolescents With Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04536480.

All > Type 2 Diabetes