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.
Eligible Conditions
- Type 2 Diabetes
- Phototherapy Complications
- Time-Restricted Feeding
Treatment Effectiveness
Effectiveness Progress
Study Objectives
7 Primary · 6 Secondary · Reporting Duration: 16 weeks
16 weeks
24-hour C-peptide levels
24-hour glucose levels
24-hour insulin levels
Beta-cell responsivity index (a measure of beta-cell function)
Cortisol Amplitude
Cortisol Phase
Glycemic ("Peripheral") Rhythm Amplitude
Glycemic ("Peripheral") Rhythm Phase
Hemoglobin A1C
Insulin secretion
Insulin sensitivity
Melatonin Amplitude
Melatonin Phase
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
No change in eating or light exposure habits
1 of 4
Early Time-Restricted Feeding
1 of 4
Early Time-Restricted Feeding and Timed Light Therapy
1 of 4
Timed Light Therapy
1 of 4
Active Control
Experimental Treatment
344 Total Participants · 4 Treatment Groups
Primary Treatment: Early Time-Restricted Feeding · No Placebo Group · N/A
Early Time-Restricted FeedingExperimental Group · 2 Interventions: Early Time-Restricted Feeding, No change in light exposure · Intervention Types: Behavioral, Behavioral
Early Time-Restricted Feeding and Timed Light TherapyExperimental Group · 2 Interventions: Early Time-Restricted Feeding, Timed Light Therapy · Intervention Types: Behavioral, Behavioral
Timed Light TherapyExperimental Group · 2 Interventions: No change in meal timing, Timed Light Therapy · Intervention Types: Behavioral, Behavioral
No change in eating or light exposure habitsActiveComparator Group · 2 Interventions: No change in light exposure, No change in meal timing · Intervention Types: Behavioral, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Early Time-Restricted Feeding
2018
N/A
~90
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 16 weeks
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,436 Previous Clinical Trials
2,228,920 Total Patients Enrolled
Courtney Peterson, Ph.D.Principal InvestigatorUniversity of Alabama at Birmingham
Eligibility Criteria
Age 30 - 80 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a HbA1c between 7.0 - 10.
You wake up at a regular time between 5-9 am.
You have had your HbA1c values measured within the past 6 months.
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Conditions
Cancer Related
Treatments