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Impact of Circadian Misalignment on Insulin Sensitivity

Impact of Circadian Misalignment on Insulin Sensitivity - Circadian misalignment and insulin sensitivity

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45941
Enrollment
26
Registered
2015-11-16
Start date
2016-01-15
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin resistance type 2 diabetes mellitus

Interventions

The study contains a behavioural intervention. During the 3.5 day misalignment condition, subjects will shift their day-night rhythm by 12 hours, which will lead to maximal circadian misalignment. D

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Insulin sensitivity of the whole body and the liver by 2-step hyperinsulinemic euglycemic clamp combined with tracer kinetics and indirect calorimetry.

Secondary

MeasureTime frame
oxidative and non-oxidative glucose disposal; skeletal muscle mitochondrial function (O2-flux pmol mg-1 s-1); whole-body energy metabolism at sleep (SMR) and while awake (resting metabolic rate); skeletal muscle mtDNA, mRNA and protein levels of markers involved in the molecular clock, mitochondrial biogenesis, mitochondrial function and insulin mediated pathways; metabolic compounds in the blood (e.g. glucose, insulin, FFA*s, cholesterol) during circadian alignment and misalignment; temperature by telemetry sensor; peripheral body temperature at distal and proximal location. Heart rate (chest impedance).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)