Day-Night Rhythm in Human Skeletal Muscle

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Insulin Resistance; Diabetes Mellitus, Type 2

Treatments: Other: Standardized living protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT02261168

METC143027

NL49363.068.14 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Standardized living protocol

Other group

Description:

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.

Treatment:

Other: Standardized living protocol