NCT04155619

Brief Summary

The purpose of this study is to test whether eating earlier in the day and/or timed light therapy can improve blood sugar in people with type 2 diabetes. This study will also test whether these treatments improve other aspects of health, including the circadian (biological) clock, sleep, weight, body composition, cardiovascular health, quality of life, and mood.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
344

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
3mo left

Started Apr 2021

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Apr 2021Aug 2026

First Submitted

Initial submission to the registry

November 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
1.5 years until next milestone

Study Start

First participant enrolled

April 26, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

4.9 years

First QC Date

November 5, 2019

Last Update Submit

January 20, 2026

Conditions

Diabetes Mellitus, Type 2Time Restricted FeedingLight; Therapy, Complications

Outcome Measures

Primary Outcomes (7)

  • 24-hour glucose levels

    Time-weighted mean, fasting, peak, standard deviation, and excursion (maximum - minimum) values (mg/dl)

    16 weeks

  • 24-hour insulin levels

    Time-weighted mean, fasting, peak, standard deviation, and excursion values (mU/l)

    16 weeks

  • 24-hour C-peptide levels

    Time-weighted mean, fasting, peak, standard deviation, and excursion values (pmol/l). This is also a proxy for total 24-hour insulin secretion.

    16 weeks

  • Hemoglobin A1C

    %

    16 weeks

  • Insulin sensitivity

    Insulin sensitivity (dl/kg/min/μU/ml) during three identical meal tolerance tests, as measured by the Oral Minimal Model. The individual, mean, and excursion values, and time of the peak value will also be calculated.

    16 weeks

  • Beta-cell responsivity index (a measure of beta-cell function)

    Beta-cell responsivity during three identical meal tolerance tests, as measured by the Oral Minimal Model. The individual, mean, and excursion values, and time of the peak value will also be calculated.

    16 weeks

  • Insulin secretion

    Insulin secretion (mU) across three identical meal tolerance tests, as measured by the Oral Minimal Model. The individual, mean, and excursion values, and time of the peak value will also be calculated.

    16 weeks

Secondary Outcomes (6)

  • Melatonin Amplitude

    16 weeks

  • Cortisol Amplitude

    16 weeks

  • Melatonin Phase

    16 weeks

  • Cortisol Phase

    16 weeks

  • Glycemic ("Peripheral") Rhythm Amplitude

    16 weeks

  • +1 more secondary outcomes

Study Arms (4)

No change in eating or light exposure habits

ACTIVE COMPARATOR
Behavioral: No change in meal timingBehavioral: No change in light exposure

Early Time-Restricted Feeding

EXPERIMENTAL
Behavioral: No change in light exposureBehavioral: Early Time-Restricted Feeding

Timed Light Therapy

EXPERIMENTAL
Behavioral: No change in meal timingBehavioral: Timed Light Therapy

Early Time-Restricted Feeding and Timed Light Therapy

EXPERIMENTAL
Behavioral: Early Time-Restricted FeedingBehavioral: Timed Light Therapy

Interventions

No change in light exposureBEHAVIORAL

Participants will not change their light exposure habits.

Early Time-Restricted FeedingNo change in eating or light exposure habits
Early Time-Restricted FeedingBEHAVIORAL

Participants will eat within an 8-hour daily period early in the day, starting within 2 hours of waking up.

Also known as: eTRF, early TRF
Early Time-Restricted FeedingEarly Time-Restricted Feeding and Timed Light Therapy
Timed Light TherapyBEHAVIORAL

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.

Also known as: Bright Light Therapy
Early Time-Restricted Feeding and Timed Light TherapyTimed Light Therapy
No change in meal timingBEHAVIORAL

Participants will eat within an ≥11-hour daily period (no change in meal timing habits).

No change in eating or light exposure habitsTimed Light Therapy

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 30-80 years old
  • 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

You may not qualify if:

  • On insulin or diabetes medication other than metformin, DPP-IV inhibitors, SGLT2 inhibitors, sulfonylureas, and/or GLP-1 receptor agonists
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham; Birmingham Veterans Affairs Medical Center

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Intermittent Fasting

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesFastingFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

PhototherapyTherapeutics

Study Officials

  • Courtney Peterson, Ph.D.

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The study statistician will be blinded. To the degree possible for each task, other study staff will be blinded during outcome assessments and analysis.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 5, 2019

First Posted

November 7, 2019

Study Start

April 26, 2021

Primary Completion

April 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Locations

US(1)