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Time-Restricted Feeding + Light Therapy for Type 2 Diabetes

N/A

Recruiting

Led By Courtney Peterson, Ph.D.

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 30-80 years old

On a stable dose of metformin, sulfonylureas, DPP-IV inhibitors, and/or GLP-1 receptor agonists for at least 6 months, or taking no diabetes medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

Study Summary

This trial will test whether eating earlier in the day and/or light therapy can improve blood sugar and other aspects of health in people with type 2 diabetes.

Who is the study for?

Adults aged 30-80 with type 2 diabetes, HbA1c levels between 7.0 - 10.0%, and waking up between 5-9 am can join this trial if they're on stable diabetes medication or none at all. Excluded are those with severe health issues like unstable heart or liver disease, major psychiatric conditions, outdoor activity over 1.5 hours/day, recent significant weight changes, or travel plans that disrupt time zones during the study.Check my eligibility

What is being tested?

The study is examining if eating earlier in the day combined with timed light therapy can better manage blood sugar in type 2 diabetics compared to no change in meal timing or light exposure. It will also assess effects on sleep, weight, body composition, cardiovascular health, quality of life and mood.See study design

What are the potential side effects?

While not explicitly stated for this trial's interventions (Early Time-Restricted Feeding and Timed Light Therapy), potential side effects may include discomfort from changing eating habits and possible eye strain or sleep disturbances from light therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 30 and 80 years old.

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I have been on the same diabetes medication for at least 6 months or am not taking any.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 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

24-hour C-peptide levels

24-hour glucose levels

24-hour insulin levels

+4 more

Secondary outcome measures

Cortisol Amplitude

Cortisol Phase

Glycemic ("Peripheral") Rhythm Amplitude

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Timed Light TherapyExperimental Treatment2 Interventions

Group II: Early Time-Restricted Feeding and Timed Light TherapyExperimental Treatment2 Interventions

Group III: Early Time-Restricted FeedingExperimental Treatment2 Interventions

Group IV: No change in eating or light exposure habitsActive Control2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Early Time-Restricted Feeding

2018

N/A

~90

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,010 Total Patients Enrolled

Courtney Peterson, Ph.D.Principal InvestigatorUniversity of Alabama at Birmingham

Media Library

Type 2 Diabetes Research Study Groups: No change in eating or light exposure habits, Early Time-Restricted Feeding, Timed Light Therapy, Early Time-Restricted Feeding and Timed Light Therapy

Type 2 Diabetes Clinical Trial 2023: Early Time-Restricted Feeding Highlights & Side Effects. Trial Name: NCT04155619 — N/A

Early Time-Restricted Feeding 2023 Treatment Timeline for Medical Study. Trial Name: NCT04155619 — N/A

Frequently Asked Questions

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

Is eligibility for this experiment limited to individuals below a certain age?

"Potential research participants must be 30 years or older, yet no more than 80 years of age."

Answered by AI

Are researchers still seeking participants for this clinical research?

"Absolutely. Per the clinicaltrials.gov website, this research trial which was first publicized on April 26th 2021 is actively recruiting participants. A total of 344 patients are required to be recruited at 1 specific medical centre."

Answered by AI

What does the research hope to prove from this clinical experiment?

"The primary outcome that this 16-week trial will measure is the 24-hour glucose level. Additionally, Melatonin Amplitude (peak value), Cortisol Amplitude (amplitude in micrograms per decilitre) and Glycemic ("Peripheral") Rhythm Amplitude (diurnal variation of mg/dL during a constant infusion procedure) are all secondary objectives."

Answered by AI

What criteria must individuals fulfill to be eligible for this experiment?

"The researchers are searching for 344 individuals aged 30-80 with diabetes mellitus, type 2 and who adhere to a strict morning routine between 5-9 am."

Answered by AI

What is the cap for participants in this research trial?

"Affirmative, clinicaltrials.gov shows that this trial is actively enrolling patients and was initially posted on April 26th 2021. The study has since been updated as lately as May 21st 2022 with the aim of recruiting 344 individuals from 1 centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Using Early Time Restricted Feeding and Timed Light Therapy to Improve Glycemic Control in Adults With Type 2 Diabetes

Courtney M Peterson 2021. "Using Early Time Restricted Feeding and Timed Light Therapy to Improve Glycemic Control in Adults With Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04155619.

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