Diabetes Mellitus, Type 2NCT02261168
Day-Night Rhythm in Human Skeletal Muscle
A study testing Standardized living protocol 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 evaluates the existence of a day-night rhythm in skeletal muscle energy metabolism in healthy lean subjects. Subjects will stay at the research facility for 44 hours with a standardized living protocol during which several measurements of skeletal muscle and whole body energy metabolism will be performed. 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?
- Standardized living protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2014to Jul 2015
- 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)
Who cannot join
- Extreme early bird or extreme night person (score ≤30 or ≥70 on MEQ-SA questionnaire)
- Heavily varying sleep-wake rhythm
- Shiftwork during last 3 months
- Travel across >1 time zone in the last 3 months
- Engagement in exercise > 2 hours total per week
- Using >400mg caffeine daily
Show all 11Show 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
- Any contra-indication to Magnetic Resonance Imaging (MRI) scanning
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Day-night Rhythm in Human Skeletal Muscle Metabolism
This study evaluates the existence of a day-night rhythm in skeletal muscle energy metabolism in healthy lean subjects. Subjects will stay at the research facility for 44 hours with a standardized living protocol during which several measurements of skeletal muscle and whole body energy metabolism will be performed.
Read the detailed description
Recent evidence from both observational and experimental studies indicates that disobeying our normal day-night rhythm negatively influences our metabolic and cardiovascular health, possibly leading to obesity and type 2 diabetes mellitus (T2DM). An important hallmark of obesity and T2DM is a decreased skeletal muscle mitochondrial function. Interestingly, recent research indicates that also skeletal muscle mitochondrial function under the influence of a day-night rhythm. The main objective of this study is to investigate the presence of a day-night rhythm in skeletal muscle energy metabolism (in particular mitochondrial function) of healthy young participants. Therefore, subjects will stay at the research unit for 44 hours, with standardized meals and sleeping time. During this period we will take five muscle biopsies, perform indirect calorimetry measurements and blood draws.
- Conditions
- Diabetes Mellitus, Type 2, Insulin Resistance
- Being tested
- Standardized living protocol
- Keywords
- Circadian Rhythm
- 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.
Standardized living protocolOther
Subjects stay at the research facility for 44 hours and adhere to a standard sleeping, eating and activity protocol. During this protocol, multiple measurements will be performed including skeletal muscle biopsies (m. vastus lateralis), blood draws, indirect calorimetry and MRS measurements.
| Study group | Role | What they receive |
|---|---|---|
| Standardized living protocol | Other | Subjects are kept at the research facility to adhere to a standardized living protocol, mimicking a normal daily living situation. During the study, multiple tests will be performed, including muscle biopsies, blood draws, MRS measurements and indirect calorimetry. Receives: Other: Standardized living protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day-night rhythm in skeletal muscle mitochondrial respiration
O2-flux (pmol/mg/s) measured with high resolution respirometry upon administration of different substrates
Measured: 40 hours.
Secondary outcomes (6)
Day-night rhythm in whole-body energy metabolism
Energy expenditure (kJ/min), glucose oxidation (g/min) and fat oxidation (g/min) measured by indirect calorimetry
Measured: 40 hours.
Day-night rhythm in muscle DNA, mRNA and protein levels of markers involved in molecular clock and mitochondrial metabolism.
Quantify mRNA and protein levels by qPCR or micro-array and Western blots
Measured: 40 hours.
Day-night rhythm of in markers of normal day-night rhythm (cortisol, melatonin, core body temperature)
Blood cortisol and melatonin levels and core body temperature measured by an ingested telemetric pill.
Measured: measured during the 2nd study day
Day-night rhythm in blood metabolic compounds (e.g. glucose, insulin, FFA's, cholesterol)
Measured: measured during the 2nd study day
Day-night rhythm of molecular clock mRNA and protein levels in blood PBMC's
Measured by qPCR and Western Blots
Measured: measured during the 2nd study day
Change in liver volume and liver lipid concentration during the day
Measured by Magnetic Resonance Imaging and -Spectroscopy (MRI/MRS). Lipid signals in the MRS spectra will be quantified while suppressing the strong water signal in the region of interest (right liver lobe)
Measured: First study day 6 PM, second study day 7 AM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionJul 2015
- Study completionJul 2015
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.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261168
- Sponsor's protocol ID
- METC143027
- Other IDs
- NL49363.068.14
- Status last verified
- Sep 2015
- First submitted
- 24 Sep 2014
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Day-night Rhythm in Human Skeletal Muscle Metabolism
- ClinicalTrials.gov ID
- NCT02261168
- Acronym / sponsor ID
- METC143027
- Conditions
- Diabetes Mellitus, Type 2, Insulin Resistance
- Keywords
- Circadian Rhythm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Oct 2014 (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 evaluates the existence of a day-night rhythm in skeletal muscle energy metabolism in healthy lean subjects. Subjects will stay at the research facility for 44 hours with a standardized living protocol during which several measurements of skeletal muscle and whole body energy metabolism will be performed.
Detailed description
Recent evidence from both observational and experimental studies indicates that disobeying our normal day-night rhythm negatively influences our metabolic and cardiovascular health, possibly leading to obesity and type 2 diabetes mellitus (T2DM). An important hallmark of obesity and T2DM is a decreased skeletal muscle mitochondrial function. Interestingly, recent research indicates that also skeletal muscle mitochondrial function under the influence of a day-night rhythm. The main objective of this study is to investigate the presence of a day-night rhythm in skeletal muscle energy metabolism (in particular mitochondrial function) of healthy young participants. Therefore, subjects will stay at the research unit for 44 hours, with standardized meals and sleeping time. During this period we will take five muscle biopsies, perform indirect calorimetry measurements and blood draws.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standardized living protocol | Other | Other: Standardized living protocolSubjects are kept at the research facility to adhere to a standardized living protocol, mimicking a normal daily living situation. During the study, multiple tests will be performed, including muscle biopsies, blood draws, MRS measurements and indirect calorimetry. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 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 (11 listed)
- Extreme early bird or extreme night person (score ≤30 or ≥70 on MEQ-SA questionnaire)
- Heavily varying sleep-wake rhythm
- Shiftwork during last 3 months
- Travel across >1 time zone in the last 3 months
- Engagement in exercise > 2 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 |
|---|---|---|
| Standardized living protocolSubjects stay at the research facility for 44 hours and adhere to a standard sleeping, eating and activity protocol. During this protocol, multiple measurements will be performed including skeletal muscle biopsies (m. vastus lateralis), blood draws, indirect calorimetry and MRS measurements. | Other | Standardized living protocol |
Primary outcome
Day-night rhythm in skeletal muscle mitochondrial respiration
Time frame: 40 hours.
O2-flux (pmol/mg/s) measured with high resolution respirometry upon administration of different substrates
6 secondary outcomes
Day-night rhythm in whole-body energy metabolism
Time frame: 40 hours.
Day-night rhythm in muscle DNA, mRNA and protein levels of markers involved in molecular clock and mitochondrial metabolism.
Time frame: 40 hours.
Day-night rhythm of in markers of normal day-night rhythm (cortisol, melatonin, core body temperature)
Time frame: measured during the 2nd study day
Day-night rhythm in blood metabolic compounds (e.g. glucose, insulin, FFA's, cholesterol)
Time frame: measured during the 2nd study day
Day-night rhythm of molecular clock mRNA and protein levels in blood PBMC's
Time frame: measured during the 2nd study day
Change in liver volume and liver lipid concentration during the day
Time frame: First study day 6 PM, second study day 7 AM
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 7 Sep 2015.
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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
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized living protocol 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 6 inclusion and 11 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 7 Sep 2015. 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?
Day-night rhythm in skeletal muscle mitochondrial respiration (time frame: 40 hours.). 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 7 Sep 2015.