Day-night Rhythm in Muscle Metabolism of Prediabetics
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus-type-2
Started Jul 2018
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 9, 2018
CompletedFirst Submitted
Initial submission to the registry
September 19, 2018
CompletedFirst Posted
Study publicly available on registry
November 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2019
CompletedAugust 16, 2019
September 1, 2018
8 months
September 19, 2018
August 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Day-night rhythm in skeletal muscle mitochondrial respiration
O2-flux (pmol/mg/s) measured with high resolution respirometry
measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00
Secondary Outcomes (16)
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 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 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 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
- +11 more secondary outcomes
Study Arms (1)
Standardized living protocol
OTHERSubjects 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Caucasian
- Healthy (as determined by dependent physician)
- Overweight: BMI 25 - 35 kg/m2
- Prediabetic based on one or a combination of the following criteria:
- Impaired Glucose Tolerance (IGT): plasma glucose values ≥ 7.8 mmol/l and ≤ 11.1 mmol/l 120 minutes after glucose drink consumption during OGTT in screening.
- Impaired Fasting Glucose (IFG): Fasting plasma glucose ≥ 6.1 mmol/l and ≤ 6.9 mmol/l.
- Insulin Resistance: glucose clearance rate ≤ 360ml/kg/min, as determined using the OGIS120 model.
- HbA1c of 5.7-6.4%.
- Regular sleeping time (normally 7 - 9h daily)
- Stable dietary habits: no weight gain or loss \> 3kg in the last three months.
You may not qualify if:
- Use of anticoagulants
- Previously diagnosed with type 2 diabetes
- Current alcohol consumption \> 20 grams alcohol/day
- Extreme early bird or extreme night person (score ≤ 30 or ≥ 70 on MEQ-SA questionnaire)
- Heavily varying sleep-wake rhythm
- Nightshift work during last 3 months
- Travel across \> 1 time zone in the last 3 months
- Significant food allergies/intolerance (seriously hampering study meals)
- Using \> 400mg caffeine daily (more than 4 coffee or energy drink)
- Smoking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maastricht Universitylead
- Maastricht University Medical Centercollaborator
Study Sites (1)
Maastricht University
Maastricht, Limburg, 6229 ER, Netherlands
Related Publications (1)
Wefers J, Connell NJ, Fealy CE, Andriessen C, de Wit V, van Moorsel D, Moonen-Kornips E, Jorgensen JA, Hesselink MKC, Havekes B, Hoeks J, Schrauwen P. Day-night rhythm of skeletal muscle metabolism is disturbed in older, metabolically compromised individuals. Mol Metab. 2020 Nov;41:101050. doi: 10.1016/j.molmet.2020.101050. Epub 2020 Jul 11.
PMID: 32659272DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick Schrauwen, PhD
Maastricht University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2018
First Posted
November 7, 2018
Study Start
July 9, 2018
Primary Completion
March 20, 2019
Study Completion
March 29, 2019
Last Updated
August 16, 2019
Record last verified: 2018-09