NCT02580513

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

June 9, 2017

Status Verified

June 1, 2017

Enrollment Period

1.1 years

First QC Date

October 14, 2015

Last Update Submit

June 8, 2017

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Keywords

Circadian RhythmCircadian MisalignmentInsulin Sensitivity

Outcome Measures

Primary Outcomes (1)

  • Insulin Sensitivity

    Measured with hyperinsulinemic euglycemic clamp

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

Secondary Outcomes (13)

  • Oxidative glucose disposal

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

  • Non-oxidative glucose disposal

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

  • Skeletal muscle mitochondrial function

    1 and 2 days after circadian misalignment and matched times in control arm

  • Whole body energy metabolism while awake

    1 and 2 days after circadian misalignment and matched times in control arm

  • Sleeping metabolic rate

    1.5 days after circadian misalignment and matched time in control arm

  • +8 more secondary outcomes

Study Arms (2)

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.

Behavioral: Circadian Misalignment

Interventions

Circadian MisalignmentBEHAVIORAL
Circadian Misalignment

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Patrick Schrauwen, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2015

First Posted

October 20, 2015

Study Start

January 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

June 9, 2017

Record last verified: 2017-06

Locations

NL(1)