NCT02261168

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

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

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable diabetes-mellitus-type-2

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 10, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 7, 2015

Status Verified

September 1, 2015

Enrollment Period

8 months

First QC Date

September 24, 2014

Last Update Submit

September 4, 2015

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Keywords

Circadian Rhythm

Outcome Measures

Primary Outcomes (1)

  • Day-night rhythm in skeletal muscle mitochondrial respiration

    O2-flux (pmol/mg/s) measured with high resolution respirometry upon administration of different substrates

    40 hours.

Secondary Outcomes (6)

  • Day-night rhythm in whole-body energy metabolism

    40 hours.

  • Day-night rhythm in muscle DNA, mRNA and protein levels of markers involved in molecular clock and mitochondrial metabolism.

    40 hours.

  • Day-night rhythm of in markers of normal day-night rhythm (cortisol, melatonin, core body temperature)

    measured during the 2nd study day

  • Day-night rhythm in blood metabolic compounds (e.g. glucose, insulin, FFA's, cholesterol)

    measured during the 2nd study day

  • Day-night rhythm of molecular clock mRNA and protein levels in blood PBMC's

    measured during the 2nd study day

  • +1 more secondary outcomes

Study Arms (1)

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.

Other: Standardized living protocol

Interventions

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.

Standardized living protocol

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)

You may not qualify if:

  • 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
  • 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

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

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2014

First Posted

October 10, 2014

Study Start

November 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

September 7, 2015

Record last verified: 2015-09

Locations

NL(1)