Maastricht University
Maastricht, Netherlands
NCT Number: NCT05263232
This study will investigate the potential benefit of scheduled natural daylight exposure to improve glucose control in type 2 diabetes (T2D) patients and to unravel molecular mechanisms underlying the effects of natural daylight on circadian clocks and (glucose) metabolism in human skeletal muscle from T2D patients. Participants will stay at our research facilities and will be exposed to natural daylight or artificial light during the daytime over 4.5 days in a randomized cross-over design. For both conditions, the evening and night will be spent under standardized dim and dark conditions.
Looking for future studies?
Notify Me40 year–75 year
All sexes
Interventional
Not applicable
Maastricht, Netherlands
Obesity and type 2 diabetes (T2D) are both strongly associated with a westernized lifestyle of low physical activity levels and high caloric intake. However, recently it has been recognized that also our 24-hour culture, characterized by working and eating late, reduced sleep (quantity and quality), and excessive light exposure in the evening and at night, should be considered as lifestyle factors that may negatively impact metabolic health. In this context, a factor that is often overlooked and underestimated is the lack of natural daylight since most people spend almost their entire work time in indoor office environments with limited access to natural daylight through windows.
Therefore, this study investigates the potential benefit of scheduled natural daylight exposure to improve glucose control in T2D individuals and to unravel molecular mechanisms underlying effects of natural daylight on circadian clocks and (glucose) metabolism in human skeletal muscle from T2D patients. For this purpose, overweight to obese T2D patients (male and female) will undergo a randomized cross-over trial in which each subject serves as its own control. Participants will stay at our research facilities and will be exposed to natural daylight or artificial light during the daytime over 4.5 days. For both conditions, the evening and night will be spent under standardized dim and dark conditions, respectively. Over these two 4.5 days intervention periods, extensive 24h metabolic profiling will be conducted, including 24h continuous glucose monitoring, 24h blood and saliva sampling, 24h blood pressure and heart rate assessments, 24h core and skin temperature assessments, 24h energy expenditure and whole-body substrate metabolism, and a skeletal muscle biopsy and a mixed meal tolerance test with indirect calorimetry will be performed on the respectively last test day.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Over 4.5 days, participants will stay at our research facilities under different light conditions. Over these days different measurements will take place, including 24h continuous glucose monitoring, 24h blood and saliva sampling, 24h blood pressure and heart rate assessments, 24h core and skin temperature assessments, 24h energy expenditure and whole-body substrate metabolism, and a skeletal muscle biopsy and a mixed meal tolerance test with indirect calorimetry will be performed on the respectively last test day.
Time frame: continously over 4.5 days
Interstistial glucose levels determined by continuous glucose monitoring
Time frame: measured at 9:00, 9:30, 10:00, 11:00, 12:00 and 13:00 on Day 5
Energy expenditure (kJ/min) measured by indirect calorimetry
Time frame: measured at 9:00, 9:30, 10:00, 11:00, 12:00 and 13:00 on Day 5
Carbohydrate oxidation (μmol/kg x min) measured by indirect calorimetry
Time frame: measured at 9:00, 9:30, 10:00, 11:00, 12:00 and 13:00 on Day 5
Fatty acid oxidation (μmol/kg x min) measured by indirect calorimetry
Time frame: measured at 9:00, 9:15, 9:30, 9:45, 10:00, 10:30, 11:00, 11:30, 12:00, 13:00 on Day 5
Plasma glucose levels determined from venous blood draws
Time frame: measured at 9:00, 9:15, 9:30, 9:45, 10:00, 10:30, 11:00, 11:30, 12:00, 13:00 on Day 5
Plasma insulin levels determined from venous blood draws
Time frame: measured at 9:00, 9:15, 9:30, 9:45, 10:00, 10:30, 11:00, 11:30, 12:00, 13:00 on Day 5
Plasma FFA levels determined from venous blood draws
Time frame: measured at 9:00, 9:15, 9:30, 9:45, 10:00, 10:30, 11:00, 11:30, 12:00, 13:00 on Day 5
Plasma triglyceride levels determined from venous blood draws
Time frame: muscle tissue taken at 7:30h on Day 5
Quantify DNA by micro-array
Time frame: muscle tissue taken at 7:30h on Day 5
in vivo culturing of primary myotubes
Time frame: measured at 8:00, 13:00, 18:00 and 22:30 on Day 4
Energy expenditure (kJ/min)
Time frame: measured at 8:00, 13:00, 18:00 and 22:30 on Day 4
Carbohydrate oxidation (μmol/kg x min) measured by indirect calorimetry
Time frame: measured at 8:00, 13:00, 18:00 and 22:30 on Day 4
Fatty acid oxidation (μmol/kg x min) measured by indirect calorimetry
Time frame: measured on Day 4 at 8:00, 10:00, 12:00, 13:00, 14:00, 16:00, 18:00, 20:00, 22:00, 23:00, and on Day 5 at 00:00, 02:00, 04:00 and 06:00h
Plasma levels determined from venous blood draws
Time frame: measured on Day 4 at 8:00, 12:00, 16:00, 20:00, and on Day 5 at 00:00, 04:00 and 8:00
analysis of all lipid species evident in serum
Time frame: after each of the 4 nights
LSEQ scores
Time frame: after each of the 4 nights
PSQI scores
Time frame: measured hourly from 7:00 to 23:00h on Day 4, and every second hour from 0:00 to 6:00 on Day 5
blood pressure (mmHg)
Time frame: measured continously over 4.5 days
heart rate (bpm) assesses through chest-worn heart rate monitor
Time frame: measured continously on Day 3
skin temperature (°C) assessed via wireless temperature sensors (iButtons)
Time frame: measured continously on Day 3
Core body temperature measured by an ingested telemetric pill (°C)
Time frame: blood samples taken on Day 4 at 8:00, 13:00, 18:00, 23:00, and on Day 5 at 4:00 and 9:00
Quantify mRNA levels by micro array
Maastricht University
Other
Natural Daylight to Improve 24h Metabolism and Glucose Control in Type 2 Diabetes
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05259449
Diabetes Mellitus, Diabetes Mellitus, Type 2
Puerto Real, Cadiz, Spain
View Trial DetailsNCT03899883
Diabetes, Diabetes Complications
Aurora, Colorado, United States
View Trial DetailsNCT07251504
Diabetes Mellitus, Diabetes Mellitus, Type 2
Puerto Real, Cádiz, Spain
View Trial DetailsNCT00445627
Body Weight, Diabetes Mellitus
Bethesda, Maryland, United States
View Trial Details