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

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2, Time Restricted Feeding, Light; Therapy, Complications

In brief

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.

Key facts

Study ID

NCT04155619

Run by

University of Alabama at Birmingham

People needed

190

Starts

2021-04-26

Expected to finish

2026-04-30

Last updated by the study team

2026-06-02

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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
• 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 it is running

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

Full record on ClinicalTrials.gov

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