NCT04155619Completed
Using Early Time Restricted Feeding and Timed Light Therapy to Improve Glycemic Control in Adults With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 190 (actual)
- First submitted
- 5 Nov 2019
- Start date
- 26 Apr 2021
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Type 2 diabetes
- NCT number
- NCT04155619
What you commit to
- Study type: Interventional
- Participants enrolled: 190
- From 26 Apr 2021 to the primary completion date, 30 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Change in the dosage of a chronic medication within the past month (need to wait at least 1 month prior to baseline visit)
- 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
Other illness
- On insulin or diabetes medication other than metformin, DPP-IV inhibitors, SGLT2 inhibitors, sulfonylureas, and/or GLP-1 receptor agonists
- Moderate or severe retinopathy or other medical condition that may affect the ability to safely receive bright light therapy
- A history of severe hypoglycemia
- 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
- 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.
Lab values
- Have a clinically significant laboratory abnormality (e.g., abnormal hemoglobin levels)
Age
- Have type 1 diabetes or was diagnosed with diabetes before age 18
Other
- Pregnant or breastfeeding
- 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
Who the study is looking for
- 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
Age in the registry: 30 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama at Birmingham; Birmingham Veterans Affairs Medical Center Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.