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NCT Number: NCT02261168

Day-Night Rhythm in Human Skeletal Muscle

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

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
  • 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

Treatment and study plan

Standardized living protocol

Other

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.

Primary outcomes

  1. 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

  1. Day-night rhythm in whole-body energy metabolism

    Time frame: 40 hours.

    Energy expenditure (kJ/min), glucose oxidation (g/min) and fat oxidation (g/min) measured by indirect calorimetry

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

    Time frame: 40 hours.

    Quantify mRNA and protein levels by qPCR or micro-array and Western blots

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

    Time frame: measured during the 2nd study day

    Blood cortisol and melatonin levels and core body temperature measured by an ingested telemetric pill.

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

    Time frame: measured during the 2nd study day

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

    Time frame: measured during the 2nd study day

    Measured by qPCR and Western Blots

  6. Change in liver volume and liver lipid concentration during the day

    Time frame: First study day 6 PM, second study day 7 AM

    Measured by Magnetic Resonance Imaging and -Spectroscopy (MRI/MRS). Lipid signals in the MRS spectra will be quantified while suppressing the strong water signal in the region of interest (right liver lobe)

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Day-night Rhythm in Human Skeletal Muscle Metabolism

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 10, 2014
Registry last updated
Sep 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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