Diabetes Mellitus, Type 2NCT05263232
Metabolic Effects of Natural Office Light in Type 2 Diabetes
A study testing Natural or artificial office light exposure in people with Diabetes Mellitus, Type 2 and Circadian Dysregulation, run by Maastricht University at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Circadian Dysregulation
- What is being tested?
- Natural or artificial office light exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Mar 2022to 18 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Natural Daylight to Improve 24h Metabolism and Glucose Control in Type 2 Diabetes
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2, Circadian Dysregulation
- Being tested
- Natural or artificial office light exposure
- Keywords
- circadian rhythm
- Medical subject headings
- Diabetes Mellitus, Type 2, Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural or artificial office light exposureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Natural office light | Experimental | 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. Receives: Other: Natural or artificial office light exposure |
| Artificial office light | Experimental | Over 4.5 days, participants will stay inside in an office room from 8:00 to 17:00h with shielded windows under artificial light. Receives: Other: Natural or artificial office light exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
average 24h blood glucose levels
Interstistial glucose levels determined by continuous glucose monitoring
Measured: continously over 4.5 days
Secondary outcomes (9)
Postprandial metabolism upon a mixed-meal tolerance test (energy expenditure)
Energy expenditure (kJ/min) measured by indirect calorimetry
Measured: measured at 9:00, 9:30, 10:00, 11:00, 12:00 and 13:00 on Day 5
Postprandial metabolism upon a mixed-meal tolerance test (carbohydrate oxidation)
Carbohydrate oxidation (μmol/kg x min) measured by indirect calorimetry
Measured: measured at 9:00, 9:30, 10:00, 11:00, 12:00 and 13:00 on Day 5
Postprandial metabolism upon a mixed-meal tolerance test (fatty acid oxidation)
Fatty acid oxidation (μmol/kg x min) measured by indirect calorimetry
Measured: measured at 9:00, 9:30, 10:00, 11:00, 12:00 and 13:00 on Day 5
Postprandial plasma metabolites upon a mixed-meal tolerance test (glucose)
Plasma glucose levels determined from venous blood draws
Measured: 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
Postprandial plasma metabolites upon a mixed-meal tolerance test (insulin)
Plasma insulin levels determined from venous blood draws
Measured: 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
Postprandial plasma metabolites upon a mixed-meal tolerance test (free fatty acids)
Plasma FFA levels determined from venous blood draws
Measured: 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
Postprandial plasma metabolites upon a mixed-meal tolerance test (triglycerides)
Plasma triglyceride levels determined from venous blood draws
Measured: 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
Skeletal muscle biopsy outcomes (Circadian transciptome)
Quantify DNA by micro-array
Measured: muscle tissue taken at 7:30h on Day 5
Culturing human primary myotubes to assess circadian reporter characteristics
in vivo culturing of primary myotubes
Measured: muscle tissue taken at 7:30h on Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start16 Mar 2022
- Primary completion30 Nov 2022
- Study completion18 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Collaborators
- Velux Fonden, University of Geneva, Switzerland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263232
- Sponsor's protocol ID
- NL77984.068.21
- Status last verified
- Aug 2023
- First submitted
- 7 Jan 2022
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Daylight to Improve 24h Metabolism and Glucose Control in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05263232
- Acronym / sponsor ID
- NL77984.068.21
- Conditions
- Diabetes Mellitus, Type 2, Circadian Dysregulation
- Keywords
- circadian rhythm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- Velux Fonden, University of Geneva, Switzerland
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 18 Apr 2023 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Natural office light | Experimental | Other: Natural or artificial office light exposureOver 4.5 days, participants will stay inside in an office room from 8:00 to 17:00h with wide transparent windows under natural daylight. |
| Artificial office light | Experimental | Other: Natural or artificial office light exposureOver 4.5 days, participants will stay inside in an office room from 8:00 to 17:00h with shielded windows under artificial light. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natural or artificial office light exposureOver 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. | Other | Artificial office light, Natural office light |
Primary outcome
average 24h blood glucose levels
Time frame: continously over 4.5 days
Interstistial glucose levels determined by continuous glucose monitoring
9 secondary outcomes
Postprandial metabolism upon a mixed-meal tolerance test (energy expenditure)
Time frame: measured at 9:00, 9:30, 10:00, 11:00, 12:00 and 13:00 on Day 5
Postprandial metabolism upon a mixed-meal tolerance test (carbohydrate oxidation)
Time frame: measured at 9:00, 9:30, 10:00, 11:00, 12:00 and 13:00 on Day 5
Postprandial metabolism upon a mixed-meal tolerance test (fatty acid oxidation)
Time frame: measured at 9:00, 9:30, 10:00, 11:00, 12:00 and 13:00 on Day 5
Postprandial plasma metabolites upon a mixed-meal tolerance test (glucose)
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
Postprandial plasma metabolites upon a mixed-meal tolerance test (insulin)
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
Postprandial plasma metabolites upon a mixed-meal tolerance test (free fatty acids)
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
Postprandial plasma metabolites upon a mixed-meal tolerance test (triglycerides)
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
Skeletal muscle biopsy outcomes (Circadian transciptome)
Time frame: muscle tissue taken at 7:30h on Day 5
Culturing human primary myotubes to assess circadian reporter characteristics
Time frame: muscle tissue taken at 7:30h on Day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natural or artificial office light exposure in people with Diabetes Mellitus, Type 2 and Circadian Dysregulation, run by Maastricht University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
average 24h blood glucose levels (time frame: continously over 4.5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.