Day-Night Rhythm in Human Skeletal Muscle

NCT ID: NCT02261168

Last Updated: 2015-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-07-31

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.

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Standardized living protocol

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.

Group Type: OTHER

Standardized living protocol

Intervention Type: 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.

Interventions

Standardized living protocol

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Schrauwen, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

Maastricht University

Maastricht, , Netherlands

Countries

Netherlands

Other Identifiers

NL49363.068.14

Identifier Type: REGISTRY

Identifier Source: secondary_id

METC143027

Identifier Type: -

Identifier Source: org_study_id