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

  • STATUS
    Recruiting
  • End date
    Aug 3, 2024
  • participants needed
    344
  • sponsor
    University of Alabama at Birmingham
Updated on 3 June 2022

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.

Description

The circadian system is strongly linked to type 2 diabetes. Adults with type 2 diabetes have circadian rhythms that are both weakened and mistimed. Weak rhythms may be due to insufficient bright light exposure during the daytime, irregular meal timing, or grazing on food throughout the day. Mistiming may be due to ill-timed food intake or light exposure-such as eating later in the day or light exposure at night-which causes central and peripheral circadian clocks within the body to become out of sync (circadian misalignment). This circadian misalignment impairs glucose metabolism: data now show that eating late in the day and light exposure at night rapidly elevate glucose (blood sugar) and insulin levels in humans within days. Conversely, well-timed food intake and light exposure appear to improve glycemic (blood sugar) control, circadian rhythms, and several other aspects of health.

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.

Details
Condition Diabetes Mellitus, Type 2, Time Restricted Feeding, Light; Therapy, Complications
Treatment Early Time-Restricted Feeding, No change in meal timing, No change in light exposure, Timed Light Therapy
Clinical Study IdentifierNCT04155619
SponsorUniversity of Alabama at Birmingham
Last Modified on3 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged 30-80 years old
HbA1c between 7.0 - 10.0%
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
Stable values of HbA1c for the past 6 months (within 0.7%)
Wake up at a regular time between 5-9 am

Exclusion Criteria

On insulin or diabetes medication other than metformin, sulfonylureas, DPP-IV inhibitors, 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 2 months
Have a clinically significant laboratory abnormality (e.g., abnormal hemoglobin levels)
Severe gastrointestinal disease, major gastrointestinal surgery, or gallstones
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
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 5:30 pm
Lost or gained more than 3 kg (6.6 lbs) of weight in the past 3 months
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
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