Diabetes Mellitus, Type 2NCT03829982
The Effects of Light on Glucose Metabolism
A study testing Exposure to bright light during the day and Exposure to dim light during the day in people with Diabetes Mellitus, Type 2 and Glucose Intolerance, run by Maastricht University at 1 site in Netherlands.
Trial summary
This study evaluates the effect of bright light on postprandial blood glucose metabolism in obese subjects with impaired fasting glucose and/or impaired glucose tolerance. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Glucose Intolerance, Prediabetic State
- What is being tested?
- Exposure to bright light during the day and Exposure to dim light during the day
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Jul 2018to 7 Feb 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caucasian
- BMI 25-35 kg/m2
- Stable weight (+/- 3 kg in the last 3 months)
- One of the four criteria for prediabetes:
- Impaired fasting glucose (6.1 mM to 6.9 mM)
- Blood glucose values 7.8 - 11.1 mM 2h after glucose drink consumption during the oral glucose tolerance test (OGTT) in screening
- Insulin Resistance: glucose clearance rate ≤ 360 ml/kg/min, as determined using the oral glucose insulin sensitivity (OGIS120) index
- HbA1c of 5.7 - 6.4%.
Who cannot join
- Fasting plasma glucose ≥7.0 mM
- Blood donation one month prior to study and three months after finishing study.
- Participants with extreme chronotypes (going to bed extremely late/early).
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the effect of bright light on postprandial blood glucose metabolism in obese subjects with impaired fasting glucose and/or impaired glucose tolerance.
Read the detailed description
Light has a major influence on the biological clock and several studies suggest that bright light during the day and dim light in the evening are beneficial for the circadian timing system. Nowadays, large parts of the population spend 90% of their time indoors and are thereby exposed to artificial lighting instead of daylight. The artificial light levels are relatively low during the day and continue relatively late in the evening. The lack of a clear natural light-dark cycle could results in delayed timing of the biological clock relative to the behaviour. Optimizing the lighting conditions under controlled laboratory settings might lead to better alignment of the biological clock, which in turn could improve metabolic parameters such as glucose control.
- Being tested
- Exposure to bright light during the day, Exposure to dim light during the day
- Keywords
- Circadian Rhythm
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to bright light during the dayBehavioural
Participants will be exposed to bright light (1250 lux) between 8:00 and 18:00 and to dim light (5 lux) between 18:00 and 23:00.
Exposure to dim light during the dayBehavioural
Participants will be exposed to dim light (10 lux) between 8:00 and 18:00 and to dim light (1250 lux) between 18:00 and 23:00.
| Study group | Role | What they receive |
|---|---|---|
| bright light during the day | Experimental | Participants will be exposed to bright light (1250 lux) between 8:00 and 18:00 and to dim light (5 lux) between 18:00 and 23:00. Receives: Behavioral: Exposure to bright light during the day |
| dim light during the day | Experimental | Participants will be exposed to dim light (10 lux) between 8:00 and 18:00 and to dim light (1250 lux) between 18:00 and 23:00. Receives: Behavioral: Exposure to dim light during the day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glucose (mg/dL)
Assessed with a continuous glucose monitor (CGM)
Measured: Study Day 1-3
Secondary outcomes (7)
Glucose levels (mmol/L) in the postprandial state
venous blood draw every 30 min for 4 hours after breakfast and after dinner
Measured: Study Day 2-3
Free fatty acid levels (µmol/L) in the postprandial state
venous blood draw every 30 min for 4 hours after breakfast and after dinner
Measured: Study Day 2-3
Triglycerides levels (mmol/L) in the postprandial state
venous blood draw every 30 min for 4 hours after breakfast and after dinner
Measured: Study Day 2-3
Insulin levels (µU/mL) in the postprandial state
venous blood draw every 30 min for 4 hours after breakfast and after dinner
Measured: Study Day 2-3
Continuous interstitial glucose (mg/dL)
Assessed with continuous glucose monitor (CGM)
Measured: Study Day 1-3
Energy expenditure
continuous measurement with whole room indirect calorimetry
Measured: Study Day 1-3
Core body temperature (CBT) and skin temperature
Measured with a telemetric pill (CBT) and 14 temperature sensors (iButtons) in degrees celsius
Measured: Study Day 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start13 Jul 2018
- Primary completion7 Feb 2020
- Study completion7 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- Crossover Assignment
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University Medical Center
- Responsible party
- Sponsor
- Investigators
- Wouter van Marken Lichtenbelt, Prof. Dr., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03829982
- Sponsor's protocol ID
- NL63655.068.17
- Status last verified
- Sep 2020
- First submitted
- 10 Jan 2019
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Harmsen JF, Wefers J, Doligkeit D, Schlangen L, Dautzenberg B, Rense P, van Moorsel D, Hoeks J, Moonen-Kornips E, Gordijn MCM, van Marken Lichtenbelt WD, Schrauwen P. The influence of bright and dim light on substrate metabolism, energy expenditure and thermoregulation in insulin-resistant individuals depends on time of day. Diabetologia. 2022 Apr;65(4):721-732. doi: 10.1007/s00125-021-05643-9. Epub 2022 Feb 2.
PubMed 35106618
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Light on Glucose Metabolism
- ClinicalTrials.gov ID
- NCT03829982
- Acronym / sponsor ID
- NL63655.068.17
- Keywords
- Circadian Rhythm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- Maastricht University Medical Center
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 7 Feb 2020 (actual)
- First posted
- 4 Feb 2019 (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 evaluates the effect of bright light on postprandial blood glucose metabolism in obese subjects with impaired fasting glucose and/or impaired glucose tolerance.
Detailed description
Light has a major influence on the biological clock and several studies suggest that bright light during the day and dim light in the evening are beneficial for the circadian timing system. Nowadays, large parts of the population spend 90% of their time indoors and are thereby exposed to artificial lighting instead of daylight. The artificial light levels are relatively low during the day and continue relatively late in the evening. The lack of a clear natural light-dark cycle could results in delayed timing of the biological clock relative to the behaviour. Optimizing the lighting conditions under controlled laboratory settings might lead to better alignment of the biological clock, which in turn could improve metabolic parameters such as glucose control.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Crossover Assignment
| Arm | Type | Receives |
|---|---|---|
| bright light during the day | Experimental | Behavioral: Exposure to bright light during the dayParticipants will be exposed to bright light (1250 lux) between 8:00 and 18:00 and to dim light (5 lux) between 18:00 and 23:00. |
| dim light during the day | Experimental | Behavioral: Exposure to dim light during the dayParticipants will be exposed to dim light (10 lux) between 8:00 and 18:00 and to dim light (1250 lux) between 18:00 and 23:00. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Caucasian
- BMI 25-35 kg/m2
- Stable weight (+/- 3 kg in the last 3 months)
- One of the four criteria for prediabetes:
Key exclusion criteria (3 listed)
- Fasting plasma glucose ≥7.0 mM
- Blood donation one month prior to study and three months after finishing study.
- Participants with extreme chronotypes (going to bed extremely late/early).
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 |
|---|---|---|
| Exposure to bright light during the dayParticipants will be exposed to bright light (1250 lux) between 8:00 and 18:00 and to dim light (5 lux) between 18:00 and 23:00. | Behavioural | bright light during the day |
| Exposure to dim light during the dayParticipants will be exposed to dim light (10 lux) between 8:00 and 18:00 and to dim light (1250 lux) between 18:00 and 23:00. | Behavioural | dim light during the day |
Primary outcome
Postprandial glucose (mg/dL)
Time frame: Study Day 1-3
Assessed with a continuous glucose monitor (CGM)
7 secondary outcomes
Glucose levels (mmol/L) in the postprandial state
Time frame: Study Day 2-3
Free fatty acid levels (µmol/L) in the postprandial state
Time frame: Study Day 2-3
Triglycerides levels (mmol/L) in the postprandial state
Time frame: Study Day 2-3
Insulin levels (µU/mL) in the postprandial state
Time frame: Study Day 2-3
Continuous interstitial glucose (mg/dL)
Time frame: Study Day 1-3
Energy expenditure
Time frame: Study Day 1-3
Core body temperature (CBT) and skin temperature
Time frame: Study Day 1-3
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 24 Sep 2020.
- Derived from this study: PubMed 35106618Harmsen JF, Wefers J, Doligkeit D, Schlangen L, Dautzenberg B, Rense P, van Moorsel D, Hoeks J, Moonen-Kornips E, Gordijn MCM, van Marken Lichtenbelt WD, Schrauwen P. The influence of bright and dim light on substrate metabolism, energy expenditure and thermoregulation in insulin-resistant individuals depends on time of day. Diabetologia. 2022 Apr;65(4):721-732. doi: 10.1007/s00125-021-05643-9. Epub 2022 Feb 2.
- 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.
Wouter van Marken Lichtenbelt, Prof. Dr. principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure to bright light during the day and Exposure to dim light during the day in people with Diabetes Mellitus, Type 2 and Glucose Intolerance, 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 8 inclusion and 3 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 24 Sep 2020. 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?
Postprandial glucose (mg/dL) (time frame: Study Day 1-3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03829982, which also lists 1 linked publication.
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 24 Sep 2020.