ACTIVE_NOT_RECRUITING

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

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Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-04-26
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04155619

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 30-80 years old
  2. * Have type 2 diabetes
  3. * HbA1c between 5.7 - 12.0%
  4. * 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
  5. * Wake up at a regular time between 5-9 am
  1. * On insulin or diabetes medication other than metformin, DPP-IV inhibitors, SGLT2 inhibitors, sulfonylureas, and/or GLP-1 receptor agonists
  2. * Have type 1 diabetes or was diagnosed with diabetes before age 18
  3. * Moderate or severe retinopathy or other medical condition that may affect the ability to safely receive bright light therapy
  4. * A history of severe hypoglycemia
  5. * Change in the dosage of a chronic medication within the past month (need to wait at least 1 month prior to baseline visit)
  6. * Have a clinically significant laboratory abnormality (e.g., abnormal hemoglobin levels)
  7. * Severe gastrointestinal disease, major gastrointestinal surgery, or active gallstone disease
  8. * Cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that is unstable or may compromise study validity
  9. * Evidence of cancer (other than non-melanoma skin cancer) within the last 5 years
  10. * Pregnant or breastfeeding
  11. * Current diagnosis of a major psychiatric condition that would impair study participation
  12. * Diagnosed sleep disorder or circadian disorder that is not stabilized (sleep apnea is allowed). Those with narcolepsy will not be included.
  13. * Major changes in health or medical history in the last 3 months that could affect data validity per judgement of the study physician
  14. * Spend an average of more than 1.5 hours/day outdoors
  15. * Perform overnight shift work more than 1 day/week on average
  16. * Regularly eat within a less than a 10-hour period daily
  17. * Regularly finish eating dinner before 6:30 pm
  18. * 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
  19. * 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

Contacts and Locations

Principal Investigator

Courtney Peterson, Ph.D.
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham; Birmingham Veterans Affairs Medical Center
Birmingham, Alabama, 35294
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Courtney Peterson, Ph.D., PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-26
Study Completion Date2026-08

Study Record Updates

Study Start Date2021-04-26
Study Completion Date2026-08

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetes Mellitus, Type 2
  • Time Restricted Feeding
  • Light; Therapy, Complications