Diabetes Mellitus, Type 2NCT02580513
Circadian Misalignment and Insulin Sensitivity
A study testing Circadian Misalignment in people with Diabetes Mellitus, Type 2 and Insulin Resistance, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
This study will evaluate the effect of circadian misalignment on insulin sensitivity in healthy lean subjects in a randomized cross-over design. Subjects will be admitted to the research facility for two study periods of 3 and 3.5 days. In one of the study periods, the behavioral cycle will be shifted by 12 hours. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Insulin Resistance
- What is being tested?
- Circadian Misalignment
- 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
- Jan 2016to Feb 2017
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian
- Healthy (as determined by dependent physician based on medical questionnaire)
- Male
- Age: 18-35 years
- Normal BMI (18-25 kg/m2)
- Regular sleeping time (normally 7 - 9h daily)
- Habitual bedtime at 11 PM ± 2 hours
Who cannot join
- Extreme early bird or extreme night person
- Heavily varying sleep-wake rhythm
- Shiftwork during last 3 months
- Travel across >1 time zone in the last 3 months
- Engagement in exercise > 3 hours total per week
- Using > 400mg caffeine daily
Show all 15Show fewer
- Smoking
- Unstable body weight (weight gain or loss > 3kg in the last 3 months)
- Significant food allergies/intolerance (seriously hampering study meals)
- Participation in another biomedical study within 1 month before the first study visit
- Claustrophobia
- Medication use hampering the study (as determined by responsible physician)
- Recent blood donation.
- Any contra-indication to the telemetric pill:
- Any acute condition, exacerbation of chronic condition, or medical history that would in the investigator's opinion interfere with the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Circadian Misalignment on Insulin Sensitivity
This study will evaluate the effect of circadian misalignment on insulin sensitivity in healthy lean subjects in a randomized cross-over design. Subjects will be admitted to the research facility for two study periods of 3 and 3.5 days. In one of the study periods, the behavioral cycle will be shifted by 12 hours. Insulin sensitivity will be measured with a hyperinsulinemic euglycemic clamp.
Read the detailed description
Recent evidence shows that misalignment of the circadian rhythm (e.g. by rotating shift work) impairs glucose metabolism markedly, possibly by decreasing insulin sensitivity in peripheral tissues and liver. Nowadays our society is indispensably connected to a lifestyle that allows wakefulness at every time of the 24 hours cycle. Social jetlag is a phenomenon that affects a large part of the general population, thus circadian misalignment extends far beyond those who are on a shift work schedule. Therefore, decreased insulin sensitivity in individuals affected by circadian misalignment may help to explain the increased prevalence of T2DM in night shift workers that has been found in epidemiological studies.
The study is an interventional randomized crossover trial in which each subject serves as it owns control. For the study, the investigators ask the subjects to participate in two study periods, one of 3 days length (control condition) and the other of 3.5 days length (misalignment condition). During the 3.5 day misalignment condition, subjects will shift their day-night rhythm by 12 hours, which will lead to maximal circadian misalignment. Insulin sensitivity will be measured by a hyperinsulinemic euglycemic clamp. Secondary parameters will include ex-vivo skeletal muscle mitochondrial function and whole-body energy metabolism.
- Conditions
- Diabetes Mellitus, Type 2, Insulin Resistance
- Being tested
- Circadian Misalignment
- Keywords
- Circadian Rhythm, Circadian Misalignment, Insulin Sensitivity
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circadian MisalignmentBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 3 days with normal circadian alignment. |
| Circadian Misalignment | Experimental | 3.5 days in which the subjects will undergo a maximal circadian misalignment of 12 hours by means of a midday nap during the second day, and a subsequent start of a new normal wake period, shifted 12 hours. Receives: Behavioral: Circadian Misalignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
Measured with hyperinsulinemic euglycemic clamp
Measured: 2 days after circadian misalignment and matched time in control arm.
Secondary outcomes (13)
Oxidative glucose disposal
Measured: 2 days after circadian misalignment and matched time in control arm.
Non-oxidative glucose disposal
Measured: 2 days after circadian misalignment and matched time in control arm.
Skeletal muscle mitochondrial function
Measured with high-resolution respirometry on permeabilized muscle fibers after muscle biopsy
Measured: 1 and 2 days after circadian misalignment and matched times in control arm
Whole body energy metabolism while awake
Measured by indirect calorimetry
Measured: 1 and 2 days after circadian misalignment and matched times in control arm
Sleeping metabolic rate
Measured by indirect calorimetry
Measured: 1.5 days after circadian misalignment and matched time in control arm
Skeletal muscle mtDNA
Measured by qPCR
Measured: 1 and 2 days after circadian misalignment and matched times in control arm
Skeletal muscle mRNA
Measured by qPCR and Western Blotting
Measured: 1 and 2 days after circadian misalignment and matched times in control arm
Skeletal muscle proteins
Measured by Western Blotting
Measured: 1 and 2 days after circadian misalignment and matched times in control arm
Metabolic compounds in the blood (e.g. glucose, insulin, FFA's, Triglycerides, cholesterol)
Measured: 1 and 2 days after circadian misalignment and matched times in control arm
Core-body-temperature
Measured by a telemetric pill
Measured: 1 day after circadian misalignment and matched time in control arm
Peripheral skin temperature
Measured by skin temperature sensors
Measured: 1 day after circadian misalignment and matched time in control arm
Central skin temperature
Measured by skin temperature sensors
Measured: 1 day after circadian misalignment and matched time in control arm
Heart rate
Measured by heart rate monitor
Measured: 1 day after circadian misalignment and matched time in control arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startJan 2016
- Primary completionFeb 2017
- Study completionFeb 2017
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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Schrauwen, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580513
- Sponsor's protocol ID
- NL54897.068.15
- Status last verified
- Jun 2017
- First submitted
- 14 Oct 2015
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Circadian Misalignment on Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT02580513
- Acronym / sponsor ID
- NL54897.068.15
- Conditions
- Diabetes Mellitus, Type 2, Insulin Resistance
- Keywords
- Circadian Rhythm, Circadian Misalignment, Insulin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 20 Oct 2015 (estimated)
- 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 evaluate the effect of circadian misalignment on insulin sensitivity in healthy lean subjects in a randomized cross-over design. Subjects will be admitted to the research facility for two study periods of 3 and 3.5 days. In one of the study periods, the behavioral cycle will be shifted by 12 hours. Insulin sensitivity will be measured with a hyperinsulinemic euglycemic clamp.
Detailed description
Recent evidence shows that misalignment of the circadian rhythm (e.g. by rotating shift work) impairs glucose metabolism markedly, possibly by decreasing insulin sensitivity in peripheral tissues and liver. Nowadays our society is indispensably connected to a lifestyle that allows wakefulness at every time of the 24 hours cycle. Social jetlag is a phenomenon that affects a large part of the general population, thus circadian misalignment extends far beyond those who are on a shift work schedule. Therefore, decreased insulin sensitivity in individuals affected by circadian misalignment may help to explain the increased prevalence of T2DM in night shift workers that has been found in epidemiological studies.
The study is an interventional randomized crossover trial in which each subject serves as it owns control. For the study, the investigators ask the subjects to participate in two study periods, one of 3 days length (control condition) and the other of 3.5 days length (misalignment condition). During the 3.5 day misalignment condition, subjects will shift their day-night rhythm by 12 hours, which will lead to maximal circadian misalignment. Insulin sensitivity will be measured by a hyperinsulinemic euglycemic clamp. Secondary parameters will include ex-vivo skeletal muscle mitochondrial function and whole-body energy metabolism.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –3 days with normal circadian alignment. |
| Circadian Misalignment | Experimental | Behavioral: Circadian Misalignment3.5 days in which the subjects will undergo a maximal circadian misalignment of 12 hours by means of a midday nap during the second day, and a subsequent start of a new normal wake period, shifted 12 hours. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Caucasian
- Healthy (as determined by dependent physician based on medical questionnaire)
- Male
- Age: 18-35 years
- Normal BMI (18-25 kg/m2)
Key exclusion criteria (15 listed)
- Extreme early bird or extreme night person
- Heavily varying sleep-wake rhythm
- Shiftwork during last 3 months
- Travel across >1 time zone in the last 3 months
- Engagement in exercise > 3 hours total per week
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 |
|---|---|---|
| Circadian Misalignment | Behavioural | Circadian Misalignment |
Primary outcome
Insulin Sensitivity
Time frame: 2 days after circadian misalignment and matched time in control arm.
Measured with hyperinsulinemic euglycemic clamp
13 secondary outcomes
Oxidative glucose disposal
Time frame: 2 days after circadian misalignment and matched time in control arm.
Non-oxidative glucose disposal
Time frame: 2 days after circadian misalignment and matched time in control arm.
Skeletal muscle mitochondrial function
Time frame: 1 and 2 days after circadian misalignment and matched times in control arm
Whole body energy metabolism while awake
Time frame: 1 and 2 days after circadian misalignment and matched times in control arm
Sleeping metabolic rate
Time frame: 1.5 days after circadian misalignment and matched time in control arm
Skeletal muscle mtDNA
Time frame: 1 and 2 days after circadian misalignment and matched times in control arm
Skeletal muscle mRNA
Time frame: 1 and 2 days after circadian misalignment and matched times in control arm
Skeletal muscle proteins
Time frame: 1 and 2 days after circadian misalignment and matched times in control arm
Metabolic compounds in the blood (e.g. glucose, insulin, FFA's, Triglycerides, cholesterol)
Time frame: 1 and 2 days after circadian misalignment and matched times in control arm
Core-body-temperature
Time frame: 1 day after circadian misalignment and matched time in control arm
Peripheral skin temperature
Time frame: 1 day after circadian misalignment and matched time in control arm
Central skin temperature
Time frame: 1 day after circadian misalignment and matched time in control arm
Heart rate
Time frame: 1 day after circadian misalignment and matched time in control arm
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 9 Jun 2017.
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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.
Patrick Schrauwen, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circadian Misalignment in people with Diabetes Mellitus, Type 2 and Insulin Resistance, run by Maastricht University Medical Center 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 7 inclusion and 15 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 9 Jun 2017. 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?
Insulin Sensitivity (time frame: 2 days after circadian misalignment and matched time in control arm.). 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 9 Jun 2017.