Using Early Time Restricted Feeding and Timed Light Therapy to Improve Glycemic Control in Adults With Type 2 Diabetes
NCT ID: NCT04155619
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
344 participants
INTERVENTIONAL
2021-04-26
2026-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Application of Time Restriction Feeding in Patients With Type 2 Diabetes Mellitus
NCT05015504
Low-Carb/Time-restricted Feeding Protocol in Insulin-Using Type 2 Diabetics
NCT04558827
Personalized Nutrition Therapy Using Continuous Glucose Monitoring to Improve Outcomes in Type 2 Diabetes Mellitus
NCT06465693
Time-Restricted Eating for Type II Diabetes: TRE-T2D
NCT05365529
Morning Light Treatment to Improve Glucose Metabolism
NCT03188263
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This study will test the health effects of eating early in the daytime (early time-restricted feeding; early TRF) and timed light therapy in adults with type 2 diabetes. The study will test the following aims:
1. Determine whether early TRF and/or timed light therapy improve glycemic control
2. (a) Determine how early TRF and/or timed light therapy affect the central and peripheral circadian clocks and (b) determine which patients benefit the most from circadian-based therapies
3. Determine whether early TRF and/or timed light therapy improve sleep, body weight, body composition, cardiovascular risk factors, quality of life, and psychological health.
Approximately 344 veterans and civilians aged 30-80 with insulin-independent type 2 diabetes will be randomized to the following 2 x 2 study design:
1. No change in eating or light exposure habits
2. Early TRF
3. Timed light therapy
4. Early TRF and timed light therapy
Participants will be asked to follow their assigned treatment for 16 weeks and then be followed up for an additional eight months (1 year in total). Baseline and post-intervention testing will be conducted during a 38-hour inpatient (hospital) stay. Testing will involve three 3-hour meal tolerance tests to determine insulin sensitivity and secretion; 24-hour measurement of glucose, insulin, and C-peptide levels; 24-hour measurement of cortisol and melatonin to measure the phase and amplitude of the central clock; and a constant glucose infusion to determine the phase and amplitude of the effective glycemic ("peripheral") circadian clock. Sleep, weight loss, body composition, and cardiovascular risk factors will also be measured, and questionnaires and an interview will be administered to determine improvements in quality of life and psychological health.
Note: Pre-registered primary and secondary outcomes are listed below. Pre-registered tertiary outcomes appear in the study protocol, which will be uploaded to this website.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
No change in eating or light exposure habits
No change in meal timing
Participants will eat within an ≥11-hour daily period (no change in meal timing habits).
No change in light exposure
Participants will not change their light exposure habits.
Early Time-Restricted Feeding
No change in light exposure
Participants will not change their light exposure habits.
Early Time-Restricted Feeding
Participants will eat within an 8-hour daily period early in the day, starting within 2 hours of waking up.
Timed Light Therapy
No change in meal timing
Participants will eat within an ≥11-hour daily period (no change in meal timing habits).
Timed Light Therapy
Participants will use bright light therapy for 60 minutes between 6 am - 3 pm, blue light-blocking glasses for one hour before bedtime, and blackout curtains at night.
Early Time-Restricted Feeding and Timed Light Therapy
Early Time-Restricted Feeding
Participants will eat within an 8-hour daily period early in the day, starting within 2 hours of waking up.
Timed Light Therapy
Participants will use bright light therapy for 60 minutes between 6 am - 3 pm, blue light-blocking glasses for one hour before bedtime, and blackout curtains at night.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No change in meal timing
Participants will eat within an ≥11-hour daily period (no change in meal timing habits).
No change in light exposure
Participants will not change their light exposure habits.
Early Time-Restricted Feeding
Participants will eat within an 8-hour daily period early in the day, starting within 2 hours of waking up.
Timed Light Therapy
Participants will use bright light therapy for 60 minutes between 6 am - 3 pm, blue light-blocking glasses for one hour before bedtime, and blackout curtains at night.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Have type 2 diabetes
* HbA1c between 5.7 - 12.0%
* On a stable dose of metformin, DPP-IV inhibitors, SGLT2 inhibitors, sulfonylureas, and/or GLP-1 receptor agonists for at least 6 weeks, or taking no diabetes medications
* Wake up at a regular time between 5-9 am
Exclusion Criteria
* Have type 1 diabetes or was diagnosed with diabetes before age 18
* Moderate or severe retinopathy or other medical condition that may affect the ability to safely receive bright light therapy
* A history of severe hypoglycemia
* Change in the dosage of a chronic medication within the past month (need to wait at least 1 month prior to baseline visit)
* Have a clinically significant laboratory abnormality (e.g., abnormal hemoglobin levels)
* Severe gastrointestinal disease, major gastrointestinal surgery, or active gallstone disease
* Cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that is unstable or may compromise study validity
* Evidence of cancer (other than non-melanoma skin cancer) within the last 5 years
* Pregnant or breastfeeding
* Current diagnosis of a major psychiatric condition that would impair study participation
* Diagnosed sleep disorder or circadian disorder that is not stabilized (sleep apnea is allowed). Those with narcolepsy will not be included.
* Major changes in health or medical history in the last 3 months that could affect data validity per judgement of the study physician
* Spend an average of more than 1.5 hours/day outdoors
* Perform overnight shift work more than 1 day/week on average
* Regularly eat within a less than a 10-hour period daily
* Regularly finish eating dinner before 6:30 pm
* Lost or gained more than 8 lbs within the last 2 months and weight needs to be stable for a minimum of 4 weeks before baseline testing
* Traveled more than two times zones away in the two months prior to enrolling in the trial or will travel more than two time zones away during the 16-week study
30 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Alabama at Birmingham
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Courtney M Peterson
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Courtney Peterson, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham; Birmingham Veterans Affairs Medical Center
Birmingham, Alabama, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
W81XWH-19-1-0558
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IRB-300003964
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.