CompletedNot Applicable

Circadian Misalignment and Insulin Sensitivity

Netherlands14 participantsStarted 2016-01

Plain-language 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. Insulin sensitivity will be measured with a hyperinsulinemic euglycemic clamp.

Who can participate

Age range

18 Years – 35 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * 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 * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Insulin Sensitivity

Timeframe: 2 days after circadian misalignment and matched time in control arm.

Trial details

NCT IDNCT02580513

SponsorMaastricht University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-02

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials