Metabolic Effects of Natural Office Light in Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2, Circadian Dysregulation
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Natural or artificial office light exposure
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type 2 focused on measuring circadian rhythm
Eligibility Criteria
Inclusion Criteria:
- Participants are able to provide signed and dates written consent prior to any study specific procedures
- Male + females (postmenopausal defined as at least 1 year post cessation of menses)
- T2DM duration at least 1 year
- BMI: ≥ 25 kg/m²
- Age: 40-75
- Well-controlled diabetes with respect to glycemic control and on stable anti-diabetes medication regimes
- Habitual bedtime of 23:00 ± 2h
- Regular sleep duration (7-9 h/night)
- Stable dietary habits: no weight gain or loss > 5 kg in the last three months
Exclusion Criteria:
- Insulin treatment
- Uncontrolled hypertension
- Signs of active diabetes-related co-morbidities like active cardiovascular diseases, active diabetic foot, polyneuropathy or retinopathy
- Signs of active liver or kidney malfunction
- Use of SGLT2 inhibitors
- Using > 400mg caffeine daily (more than 4 coffee or energy drink)
- Extreme early bird or extreme night person (score ≤30 or ≥70 on MEQ-SA questionnaire)
- shift work or travel across more than one time zone in the 3 months before the study
- Heavily varying sleep-wake rhythm
- Frequent engagement in programmed exercise as judged by the investigator
- Any medication that will interfere with the study outcomes or hamper the safety of the participant
- Alcohol consumption of >2 servings per day for men and >1 serving per day for woman
- Significant food allergies/intolerance (seriously hampering study meals)
- Subjects who do not want to be informed about unexpected medical findings during the screening /study, or do not wish that their physician is informed
- Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator
- Smoking in the past 6 months
Sites / Locations
- Maastricht University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Natural office light
Artificial office light
Arm Description
Over 4.5 days, participants will stay inside in an office room from 8:00 to 17:00h with wide transparent windows under natural daylight.
Over 4.5 days, participants will stay inside in an office room from 8:00 to 17:00h with shielded windows under artificial light.
Outcomes
Primary Outcome Measures
average 24h blood glucose levels
Interstistial glucose levels determined by continuous glucose monitoring
Secondary Outcome Measures
Postprandial metabolism upon a mixed-meal tolerance test (energy expenditure)
Energy expenditure (kJ/min) measured by indirect calorimetry
Postprandial metabolism upon a mixed-meal tolerance test (carbohydrate oxidation)
Carbohydrate oxidation (μmol/kg x min) measured by indirect calorimetry
Postprandial metabolism upon a mixed-meal tolerance test (fatty acid oxidation)
Fatty acid oxidation (μmol/kg x min) measured by indirect calorimetry
Postprandial plasma metabolites upon a mixed-meal tolerance test (glucose)
Plasma glucose levels determined from venous blood draws
Postprandial plasma metabolites upon a mixed-meal tolerance test (insulin)
Plasma insulin levels determined from venous blood draws
Postprandial plasma metabolites upon a mixed-meal tolerance test (free fatty acids)
Plasma FFA levels determined from venous blood draws
Postprandial plasma metabolites upon a mixed-meal tolerance test (triglycerides)
Plasma triglyceride levels determined from venous blood draws
Skeletal muscle biopsy outcomes (Circadian transciptome)
Quantify DNA by micro-array
Culturing human primary myotubes to assess circadian reporter characteristics
in vivo culturing of primary myotubes
Full Information
NCT ID
NCT05263232
First Posted
January 7, 2022
Last Updated
August 14, 2023
Sponsor
Maastricht University
Collaborators
Velux Fonden, University of Geneva, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT05263232
Brief Title
Metabolic Effects of Natural Office Light in Type 2 Diabetes
Official Title
Natural Daylight to Improve 24h Metabolism and Glucose Control in Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 16, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
April 18, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University
Collaborators
Velux Fonden, University of Geneva, Switzerland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Circadian Dysregulation
Keywords
circadian rhythm
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Natural office light
Arm Type
Experimental
Arm Description
Over 4.5 days, participants will stay inside in an office room from 8:00 to 17:00h with wide transparent windows under natural daylight.
Arm Title
Artificial office light
Arm Type
Experimental
Arm Description
Over 4.5 days, participants will stay inside in an office room from 8:00 to 17:00h with shielded windows under artificial light.
Intervention Type
Other
Intervention Name(s)
Natural or artificial office light exposure
Intervention Description
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.
Primary Outcome Measure Information:
Title
average 24h blood glucose levels
Description
Interstistial glucose levels determined by continuous glucose monitoring
Time Frame
continously over 4.5 days
Secondary Outcome Measure Information:
Title
Postprandial metabolism upon a mixed-meal tolerance test (energy expenditure)
Description
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
Title
Postprandial metabolism upon a mixed-meal tolerance test (carbohydrate oxidation)
Description
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
Title
Postprandial metabolism upon a mixed-meal tolerance test (fatty acid oxidation)
Description
Fatty acid 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
Title
Postprandial plasma metabolites upon a mixed-meal tolerance test (glucose)
Description
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
Title
Postprandial plasma metabolites upon a mixed-meal tolerance test (insulin)
Description
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
Title
Postprandial plasma metabolites upon a mixed-meal tolerance test (free fatty acids)
Description
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
Title
Postprandial plasma metabolites upon a mixed-meal tolerance test (triglycerides)
Description
Plasma triglyceride 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
Title
Skeletal muscle biopsy outcomes (Circadian transciptome)
Description
Quantify DNA by micro-array
Time Frame
muscle tissue taken at 7:30h on Day 5
Title
Culturing human primary myotubes to assess circadian reporter characteristics
Description
in vivo culturing of primary myotubes
Time Frame
muscle tissue taken at 7:30h on Day 5
Other Pre-specified Outcome Measures:
Title
24 hour energy expenditure
Description
Energy expenditure (kJ/min)
Time Frame
measured at 8:00, 13:00, 18:00 and 22:30 on Day 4
Title
24h whole-body energy metabolism (cabrohydrate oxidation)
Description
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
Title
24h whole-body energy metabolism (fatty acid oxidation)
Description
Fatty acid 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
Title
24h profiles of plasma metabolites (i.e. free fatty acids, triglycerides, insulin)
Description
Plasma levels determined from venous blood draws
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
Title
Mass spectrometry-based 24h serum lipidomics
Description
analysis of all lipid species evident in serum
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
Title
Sleep quality questionnaire (Leeds Sleep Evaluations Questionnaire - LSEQ)
Description
LSEQ scores
Time Frame
after each of the 4 nights
Title
Sleep quality questionnaire (Pittsburgh Sleep Quality Index - PSQI)
Description
PSQI scores
Time Frame
after each of the 4 nights
Title
24h blood pressure
Description
blood pressure (mmHg)
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
Title
24h heart rate
Description
heart rate (bpm) assesses through chest-worn heart rate monitor
Time Frame
measured continously over 4.5 days
Title
24h skin temperature
Description
skin temperature (°C) assessed via wireless temperature sensors (iButtons)
Time Frame
measured continously on Day 3
Title
24h core body temperature
Description
Core body temperature measured by an ingested telemetric pill (°C)
Time Frame
measured continously on Day 3
Title
mRNA in peripheral blood mononuclear cells (PBMC) of markers involved in the molecular clock
Description
Quantify mRNA levels by micro array
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants are able to provide signed and dates written consent prior to any study specific procedures
Male + females (postmenopausal defined as at least 1 year post cessation of menses)
T2DM duration at least 1 year
BMI: ≥ 25 kg/m²
Age: 40-75
Well-controlled diabetes with respect to glycemic control and on stable anti-diabetes medication regimes
Habitual bedtime of 23:00 ± 2h
Regular sleep duration (7-9 h/night)
Stable dietary habits: no weight gain or loss > 5 kg in the last three months
Exclusion Criteria:
Insulin treatment
Uncontrolled hypertension
Signs of active diabetes-related co-morbidities like active cardiovascular diseases, active diabetic foot, polyneuropathy or retinopathy
Signs of active liver or kidney malfunction
Use of SGLT2 inhibitors
Using > 400mg caffeine daily (more than 4 coffee or energy drink)
Extreme early bird or extreme night person (score ≤30 or ≥70 on MEQ-SA questionnaire)
shift work or travel across more than one time zone in the 3 months before the study
Heavily varying sleep-wake rhythm
Frequent engagement in programmed exercise as judged by the investigator
Any medication that will interfere with the study outcomes or hamper the safety of the participant
Alcohol consumption of >2 servings per day for men and >1 serving per day for woman
Significant food allergies/intolerance (seriously hampering study meals)
Subjects who do not want to be informed about unexpected medical findings during the screening /study, or do not wish that their physician is informed
Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator
Smoking in the past 6 months
Facility Information:
Facility Name
Maastricht University
City
Maastricht
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Metabolic Effects of Natural Office Light in Type 2 Diabetes
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