The primary objective is to investigate the potential benefit of scheduled natural daylight exposure to improve glucose control in T2DM individuals and to unravel molecular mechanisms underlying effects of natural daylight on circadian clocks and (…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is average 24h blood glucose assessed with a continuous
glucose monitor.
Secondary outcome
Secondary study endpoints refer to postprandial metabolism upon a mixed-meal
tolerance test and circadian transcriptome, lipidome and myokine secretion
analyses in skeletal muscle tissue with culturing of human primary myotubes to
assess circadian reporter characteristics.
Other exploratory parameters include:
• 24h blood profiles:
o metabolic compounds (glucose, triglycerides, free fatty acids)
o hormones (insulin)
o mass spectrometry-based lipidomics
• Sleep quality questionnaires: LSEQ and PSQI
• 24h indirect calorimetry: substrate metabolism and energy expenditure
• Actigraphy measures: activity count, sleeping times
• 24h blood pressure and heart rate (ambulatory)
• 24h saliva profiles:
o Melatonin and cortisol
• Core body temperature and skin temperatures
• mRNA and protein levels in blood PBMC*s of markers involved in the molecular
clock
• Body composition (BodPod)
Background summary
Obesity and type 2 diabetes mellitus (T2DM) 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. To date, only a limited number of studies have investigated the
effects of light on human metabolism. Of those, most have investigated
artificial light conditions exclusively. Given the fact that artificial light
is very limited in its brightness levels and mostly contains a constant
wavelength spectrum that is visible to the human eye but neither invisible
ultra-violett (UV) nor infrared radiation that are present in sunlight, this
leaves vast unprecedented territory to investigate the metabolic effects of
natural daylight. Recent human studies that investigated the physiologicals
consequences of changing the wavelength spectrum and intensity levels in
artificial indoor lighting environments but also animal studies looking at the
relevance of dosed UV light for metabolic health all suggest a positive impact
of natural daylight on human metabolism. No study has yet determined the effect
of an indoor environment that facilitates access to natural daylight through
wide windows compared to a typical artificial light environment on metabolic
outcomes in T2DM patients.
Study objective
The primary objective is to investigate the potential benefit of scheduled
natural daylight exposure to improve glucose control in T2DM individuals and to
unravel molecular mechanisms underlying effects of natural daylight on
circadian clocks and (glucose) metabolism in human skeletal muscle from T2DM
patients.
Study design
The study will be carried out as a randomized cross-over trial in which each
subject serves as its own control. Each participant will undergo two different
light exposure sessions.
Intervention
Participants will stay at our research facilities and will be exposed to
natural daylight or artificial light during daytime over 4.5 days. For both
conditions, the evening and night will be spent under standardized dim and dark
conditions.
Study burden and risks
Subjects will first visit the university once for screening purposes during
which they will fill in 2 questionnaires and a blood draw will be taken in the
fasted state. If subjects are eligible, they will visit the university 3 days
before each study period to receive a wrist-worn sleep monitoring device
(Actiwatch) and a food and sleep diary, which will be used to assess their
sleep duration and meal patterns. In summary, the pre-study visits will require
participants to stay 3 hours at the University. During the 3-day monitoring
period at home, subjects will have to adhere to a pre-determined lifestyle with
a regular sleep-wake cycle, which may limit them in their choice of daily
activities. Subjects will then visit the university for two study periods. Each
of the two study periods will require that subjects stay for 4.5 days on
university premises (2 x 103h = 206 hours in total), which will be interrupted
by at least 4 weeks time between two study periods. During daytime, subjects
will stay inside in a room with either wide transparent windows under natural
daylight or with shielded windows under artificial light. The evenings will be
spent under controlled dim light (5 lux) and nights will be spent in complete
darkness. On the 4th day, to obtain regular blood samples, an intravenous
cannula will be placed into the antecubital vein that remains in place until
the end of the study visit. A total of about 527 ml blood will be collected
during each of the two study periods. In addition, a muscle biopsy will be
performed in the morning of the last day. The blood sampling and muscle biopsy
can occasionally cause a local hematoma or bruising. The risk of infection or
prolonged bleeding is low due to state of the art techniques and sterility
measures. We hypothesize that natural daylight has a positive influence on
metabolic health of T2DM patients. However, since this is the first
investigation looking into the effect of natural daylight in T2DM patients, it
cannot be simply assumed that subjects will benefit in any way. Results of this
study will potentially reveal the importance of natural daylight for metabolic
outcomes and may hence provide a new non-pharmacological treatment strategy for
T2DM.
P.O. Box 616
Maastricht 6200 MD
NL
P.O. Box 616
Maastricht 6200 MD
NL
Listed location countries
Age
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)
• T2D 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
• engagement in programmed exercise for more than 3h/week
• Any medication that will interfere with the study outcomes or hamper the
safety of the participant
• Alcohol consumption of >2 servings per day for man and >1 serving per day for
woman
• 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, 1
month prior to the screening visit
• Significant food allergies/intolerance (seriously hampering study meals)
• Participation in another biomedical study within 1 month before the first
study visit
• Smoking in the past 6 months
A medical doctor will judge participation eligibility based on the medical
history questionnaire, medication use and fasting blood parameters. If the
medical doctor advises that a patient cannot participate, the patient will be
excluded from enrollment.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77984.068.21 |