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Impact of Circadian Misalignment on Insulin Sensitivity

Completed
Conditions
10018424
Insulin resistance
type 2 diabetes mellitus
Registration Number
NL-OMON45941
Lead Sponsor
niversiteit Maastricht
Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
17
Inclusion Criteria

* 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

Exclusion Criteria

* 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 > 3 hours total per week
* Using > 400mg caffeine daily (more than 4 coffee or energy drink)
* 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, which would possibly hamper our study results.
* Claustrophobia (Subjects will see the respiration chamber, in which they will reside, during the screening visit).
* Medication use known to hamper subject*s safety during the study procedures or to interfere with study results (as determined by responsible physician)
* Subjects who intend to donate blood during the intervention or subjects who have donated blood less than three months before the start of the intervention.
* Any contra-indication to the VitalSense telemetric pill.
* Any acute condition, exacerbation of chronic condition, or medical history that would in the investigator*s opinion interfere with the study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Insulin sensitivity of the whole body and the liver by 2-step hyperinsulinemic<br /><br>euglycemic clamp combined with tracer kinetics and indirect calorimetry.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>oxidative and non-oxidative glucose disposal; skeletal muscle mitochondrial<br /><br>function (O2-flux pmol mg-1 s-1); whole-body energy metabolism at sleep (SMR)<br /><br>and while awake (resting metabolic rate); skeletal muscle mtDNA, mRNA and<br /><br>protein levels of markers involved in the molecular clock, mitochondrial<br /><br>biogenesis, mitochondrial function and insulin mediated pathways; metabolic<br /><br>compounds in the blood (e.g. glucose, insulin, FFA*s, cholesterol) during<br /><br>circadian alignment and misalignment; temperature by telemetry sensor;<br /><br>peripheral body temperature at distal and proximal location. Heart rate (chest<br /><br>impedance).</p><br>
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