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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
Must not have
Have type 1 diabetes or was diagnosed with diabetes before age 18
A history of severe hypoglycemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have type 1 diabetes or was diagnosed with diabetes before I turned 18.
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I have had severe low blood sugar episodes.
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I have severe stomach/intestine problems, had major gut surgery, or have gallstones.
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I am on diabetes medication that is not metformin, sulfonylureas, DPP-IV inhibitors, or GLP-1 receptor agonists.
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My weight has changed by more than 6.6 lbs in the last 3 months.
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My sleep or circadian rhythm disorder is not under control.
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I have severe eye problems that could be worsened by bright light therapy.
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I do not have a major psychiatric condition that affects my daily activities.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
24-hour C-peptide levels
24-hour glucose levels
24-hour insulin levels
+3 more
Secondary study objectives
Cortisol Amplitude
Cortisol Phase
Glycemic ("Peripheral") Rhythm Amplitude
+3 more

Awards & Highlights

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

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
~130

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,645 Previous Clinical Trials
2,342,508 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
~54 spots leftby Aug 2025
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