Improving blood sugar control in adults with type 2 diabetes using early eating and light therapy
Using Early Time Restricted Feeding and Timed Light Therapy to Improve Glycemic Control in Adults With Type 2 Diabetes
This study is testing if eating earlier in the day and using light therapy can help adults with type 2 diabetes better control their blood sugar and improve their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 344 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT04155619 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of early time-restricted feeding and timed light therapy on glycemic control in adults with type 2 diabetes. It investigates how these interventions may enhance various health aspects, including circadian rhythms, sleep quality, body composition, cardiovascular health, and overall quality of life. Participants will be monitored for changes in blood sugar levels and other health metrics as they adopt these lifestyle modifications. The study seeks to identify which patients benefit most from these circadian-based therapies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30-80 with type 2 diabetes who have stable blood sugar levels and wake up regularly between 5-9 am.
Not a fit: Patients on insulin or those with type 1 diabetes or severe medical conditions affecting light therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved blood sugar management and overall health for individuals with type 2 diabetes.
How similar studies have performed: While the specific combination of early feeding and light therapy is novel, related studies have shown promising results in improving glycemic control through circadian rhythm adjustments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham; Birmingham Veterans Affairs Medical Center — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Courtney Peterson, Ph.D. — University of Alabama at Birmingham
- Study coordinator: Courtney Peterson, Ph.D.
- Email: cpeterso@uab.edu
- Phone: 205-934-0122
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.