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

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Nov 5, 2019

Keywords

ClinConnect Summary

This clinical trial is studying whether eating meals earlier in the day and getting light therapy at specific times can help improve blood sugar levels in adults with type 2 diabetes. The researchers also want to see if these changes can enhance overall health, including sleep quality, weight management, heart health, and mood.

To join the study, participants need to be between 30 and 80 years old, have type 2 diabetes, and be stable on certain diabetes medications or not on any medication at all. They should wake up regularly between 5 and 9 am. Participants can expect to follow specific eating and light therapy schedules for 16 weeks, and the study aims to gather valuable information that may lead to better management of diabetes and its related health issues. If you're interested, it's important to note the eligibility criteria, especially regarding other medical conditions or medications, as these could affect participation.

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ALL

Eligibility 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