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Clinical Trials/NCT02261168
NCT02261168
Completed
Not Applicable

Day-night Rhythm in Human Skeletal Muscle Metabolism

Maastricht University Medical Center1 site in 1 country12 target enrollmentNovember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
Maastricht University Medical Center
Enrollment
12
Locations
1
Primary Endpoint
Day-night rhythm in skeletal muscle mitochondrial respiration
Status
Completed
Last Updated
10 years ago

Overview

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.

Detailed Description

Recent evidence from both observational and experimental studies indicates that disobeying our normal day-night rhythm negatively influences our metabolic and cardiovascular health, possibly leading to obesity and type 2 diabetes mellitus (T2DM). An important hallmark of obesity and T2DM is a decreased skeletal muscle mitochondrial function. Interestingly, recent research indicates that also skeletal muscle mitochondrial function under the influence of a day-night rhythm. The main objective of this study is to investigate the presence of a day-night rhythm in skeletal muscle energy metabolism (in particular mitochondrial function) of healthy young participants. Therefore, subjects will stay at the research unit for 44 hours, with standardized meals and sleeping time. During this period we will take five muscle biopsies, perform indirect calorimetry measurements and blood draws.

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
July 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Caucasian
  • Healthy (as determined by dependent physician based on medical questionnaire)
  • Age: 18-35 years
  • Normal BMI (18-25 kg/m2)
  • Regular sleeping time (normally 7-9h daily)

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 \> 2 hours total per week
  • Using \>400mg caffeine daily
  • 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

Outcomes

Primary Outcomes

Day-night rhythm in skeletal muscle mitochondrial respiration

Time Frame: 40 hours.

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

Secondary Outcomes

  • Day-night rhythm in whole-body energy 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 muscle DNA, mRNA and protein levels of markers involved in molecular clock and mitochondrial metabolism.(40 hours.)
  • Change in liver volume and liver lipid concentration during the day(First study day 6 PM, second study day 7 AM)
  • 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)

Study Sites (1)

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