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Clinical Trials/NCT03733743
NCT03733743
Completed
Not Applicable

Day-night Rhythm in Muscle Metabolism of Prediabetic Subjects

Maastricht University1 site in 1 country12 target enrollmentJuly 9, 2018

Overview

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

Overview

Brief Summary

This study evaluates the existence of a day-night rhythm in skeletal muscle energy metabolism in prediabetic 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 disobedience of a normal day-night rhythm negatively influences 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 is under the influence of a day-night rhythm. In this study, the presence of a day-night rhythm in skeletal muscle energy metabolism (in particular mitochondrial function) of overweight prediabetic participants will be investigated. During this study, subjects will stay at the research unit for 44 hours, with standardized meals and sleeping time. Five muscle biopsies (v. lateralis) and frequent blood draws will be taken. In addition, indirect calorimetry measurements will be performed.

Registry
clinicaltrials.gov
Start Date
July 9, 2018
End Date
March 29, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Day-night rhythm in skeletal muscle mitochondrial respiration

Time Frame: measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00

O2-flux (pmol/mg/s) measured with high resolution respirometry

Secondary Outcomes

  • Day-night rhythm in whole-body energy metabolism (energy expenditure)(measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00)
  • Day-night rhythm in serum free fatty acids (FFA)(measured on day two, every two hours for 24 hours beginning at 08:00)
  • Day-night rhythm in whole-body energy metabolism (glucose oxidation)(measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00)
  • Day-night rhythm in muscle DNA involved in molecular clock and mitochondrial metabolism.(measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00)
  • Day-night rhythm of in markers of normal day-night rhythm (melatonin)(measured on day two, every two hours for 24 hours beginning at 08:00)
  • Day-night rhythm in serum triglycerides(measured on day two, every two hours for 24 hours beginning at 08:00)
  • Day-night rhythm in serum cholesterol(measured on day two, every two hours for 24 hours beginning at 08:00)
  • Change in energy status of the heart between morning and evening(Measured on first study day 5:30 PM (duration 45 minutes), second study day 7:30 AM (duration 45 minutes))
  • Day-night rhythm in whole-body energy metabolism (fat oxidation)(measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00)
  • Day-night rhythm in muscle protein levels of markers involved in molecular clock and mitochondrial metabolism.(measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00)
  • Day-night rhythm in serum glucose(measured on day two, every two hours for 24 hours beginning at 08:00)
  • Day-night rhythm in muscle DNA of markers involved in molecular clock and mitochondrial metabolism.(measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00)
  • Day-night rhythm in muscle mRNA markers involved in molecular clock and mitochondrial metabolism.(measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00)
  • Day-night rhythm of markers of normal day-night rhythm (cortisol)(measured on day two, every two hours for 24 hours beginning at 08:00)
  • Day-night rhythm of in markers of normal day-night rhythm (core body temperature)(measured continuously for 24 hours on day two)
  • Day-night rhythm in serum insulin(measured on day two, every two hours for 24 hours beginning at 08:00)

Study Sites (1)

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