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Time Limited Eating for Type 1 Diabetes (TLET1D Trial)

N/A

Waitlist Available

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

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 9 weeks; hba1c: baseline and 9 weeks

Awards & highlights

TLET1D Trial Summary

This trial is testing whether a new eating plan can help preserve beta cell function in kids with Type 1 Diabetes, in the first 6 months after diagnosis.

Eligible Conditions

Type 1 Diabetes

TLET1D Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 9 weeks; hba1c: baseline and 9 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 9 weeks; hba1c: baseline and 9 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 9 weeks; hba1c: baseline and 9 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Acceptability and feasibility of intervention, as indicated by the "Intervention Satisfaction Survey"

Change in glycemic control at 9 weeks, as indicated by continuous glucose monitoring (percent time in range), and HbA1c

Change in β-cell function at 9 weeks, as indicated by mixed meal tolerance test with C-peptide levels

+1 more

Secondary outcome measures

Anxiety, as indicated by Neuro-QOL-Anxiety-Short Form

Binge Eating, as indicated by Binge Eating Disorder Screener

Dietary patterns, as indicated by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)

+3 more

TLET1D Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention - Time Limited EatingExperimental Treatment1 Intervention

includes an 8-hour feed/16-hour fast for 7 days per week will be instructed to consume all of their calories in the afternoon/evening period can consume non-caloric beverages (water, tea, coffee) during the fasting period will wear a continuous glucose monitor no caloric restriction will be used

Group II: Control - Standard CareActive Control1 Intervention

includes a minimum 12-hour feeding window for 7 days per week no caloric restriction will be used will wear a continuous glucose monitor

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Children's Hospital Los AngelesLead Sponsor

232 Previous Clinical Trials

5,076,756 Total Patients Enrolled

Frequently Asked Questions

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

Does this clinical investigation include individuals aged 40 and above?

"The study parameters indicate that people aged 12 to 25 are eligible for this trial, with 218 studies available for minors and 924 studies accessible to seniors."

Answered by AI

Who meets the criteria to partake in this experiment?

"To be accepted into this study, applicants must have type 1 diabetes mellitus and reside between the ages of 12 to 25. Currently, 60 individuals are being recruited for participation."

Answered by AI

What is the intended outcome of this medical test?

"This medical study, which will last up to 12 weeks, aims to measure changes in beta-cell function following treatment. Secondary outcomes include physical activity frequency (recorded on a Likert scale from 0-4), quality of life (also recorded on a Likert scale from 0-4) and dietary patterns gauged by the 24 hour Automated Self Administered Dietary Assessment Tool (~30 minutes)."

Answered by AI

Is recruitment for this research endeavor still open?

"Indeed, the details found on clinicaltrials.gov verify that this study is currently accepting participants. The trial was initially shared online on January 1st 2022 and last revised on June 13th 2022. At present, 60 individuals are being enrolled across a single site."

Answered by AI

In what quantity of participants is this clinical trial involving?

"Correct. Clinicaltrials.gov confirms that this clinical investigation is actively searching for participants and was initially posted on January 1st 2022 before being modified June 13th 2022. The trial has a goal of enrolling 60 patients from one location."

Answered by AI