- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03733743
Day-night Rhythm in Muscle Metabolism of Prediabetics
August 15, 2019 updated by: Maastricht University
Day-night Rhythm in Muscle Metabolism of Prediabetic Subjects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6229 ER
- Maastricht University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion criteria:
- 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.
Exclusion criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Day-night rhythm in whole-body energy metabolism (energy expenditure)
Time Frame: measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00
|
Energy expenditure (kJ/min) measured by indirect calorimetry
|
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)
Time Frame: measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00
|
glucose oxidation (g/min) measured by indirect calorimetry
|
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)
Time Frame: measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00
|
fat oxidation (g/min) measured by indirect calorimetry
|
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.
Time Frame: measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00
|
Quantify protein levels by Western blots
|
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.
Time Frame: measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00
|
Quantify DNA by qPCR
|
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.
Time Frame: measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00
|
Quantify DNA by micro-array
|
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.
Time Frame: measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00
|
Quantify mRNA levels by micro array
|
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)
Time Frame: measured on day two, every two hours for 24 hours beginning at 08:00
|
Blood cortisol levels
|
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)
Time Frame: measured continuously for 24 hours on day two
|
Core body temperature measured by an ingested telemetric pill.
|
measured continuously for 24 hours on day two
|
Day-night rhythm of in markers of normal day-night rhythm (melatonin)
Time Frame: measured on day two, every two hours for 24 hours beginning at 08:00
|
Blood melatonin levels.
|
measured on day two, every two hours for 24 hours beginning at 08:00
|
Day-night rhythm in serum glucose
Time Frame: measured on day two, every two hours for 24 hours beginning at 08:00
|
Serum glucose levels determined from venous blood draws
|
measured on day two, every two hours for 24 hours beginning at 08:00
|
Day-night rhythm in serum insulin
Time Frame: measured on day two, every two hours for 24 hours beginning at 08:00
|
Serum insulin levels determined from venous blood draws
|
measured on day two, every two hours for 24 hours beginning at 08:00
|
Day-night rhythm in serum free fatty acids (FFA)
Time Frame: measured on day two, every two hours for 24 hours beginning at 08:00
|
Serum FFA levels determined from venous blood draws
|
measured on day two, every two hours for 24 hours beginning at 08:00
|
Day-night rhythm in serum triglycerides
Time Frame: measured on day two, every two hours for 24 hours beginning at 08:00
|
Serum triglyceride levels determined from venous blood draws
|
measured on day two, every two hours for 24 hours beginning at 08:00
|
Day-night rhythm in serum cholesterol
Time Frame: measured on day two, every two hours for 24 hours beginning at 08:00
|
Serum cholesterol levels determined from venous blood draws
|
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
Time Frame: Measured on first study day 5:30 PM (duration 45 minutes), second study day 7:30 AM (duration 45 minutes)
|
variation in phosphorus metabolites measured by Magnetic Resonance Imaging and - Spectroscopy (MRI/MRS)
|
Measured on first study day 5:30 PM (duration 45 minutes), second study day 7:30 AM (duration 45 minutes)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Patrick Schrauwen, PhD, Maastricht University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 9, 2018
Primary Completion (Actual)
March 20, 2019
Study Completion (Actual)
March 29, 2019
Study Registration Dates
First Submitted
September 19, 2018
First Submitted That Met QC Criteria
November 5, 2018
First Posted (Actual)
November 7, 2018
Study Record Updates
Last Update Posted (Actual)
August 16, 2019
Last Update Submitted That Met QC Criteria
August 15, 2019
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL64753.068.18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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