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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03733743
Other study ID # NL64753.068.18
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 9, 2018
Est. completion date March 29, 2019

Study information

Verified date September 2018
Source Maastricht University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date March 29, 2019
Est. primary completion date March 20, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 40 Years to 75 Years
Eligibility 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 Design


Intervention

Other:
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.

Locations

Country Name City State
Netherlands Maastricht University Maastricht Limburg

Sponsors (2)

Lead Sponsor Collaborator
Maastricht University Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Day-night rhythm in whole-body energy metabolism (energy expenditure) Energy expenditure (kJ/min) measured by indirect calorimetry measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00
Secondary Day-night rhythm in whole-body energy metabolism (glucose oxidation) glucose oxidation (g/min) measured by indirect calorimetry measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00
Secondary Day-night rhythm in whole-body energy metabolism (fat oxidation) fat oxidation (g/min) measured by indirect calorimetry measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00
Secondary Day-night rhythm in muscle protein levels of markers involved in molecular clock and mitochondrial metabolism. Quantify protein levels by Western blots measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00
Secondary Day-night rhythm in muscle DNA of markers involved in molecular clock and mitochondrial metabolism. Quantify DNA by qPCR measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00
Secondary Day-night rhythm in muscle DNA involved in molecular clock and mitochondrial metabolism. Quantify DNA by micro-array measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00
Secondary Day-night rhythm in muscle mRNA markers involved in molecular clock and mitochondrial metabolism. Quantify mRNA levels by micro array measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00
Secondary Day-night rhythm of markers of normal day-night rhythm (cortisol) Blood cortisol levels measured on day two, every two hours for 24 hours beginning at 08:00
Secondary Day-night rhythm of in markers of normal day-night rhythm (core body temperature) Core body temperature measured by an ingested telemetric pill. measured continuously for 24 hours on day two
Secondary Day-night rhythm of in markers of normal day-night rhythm (melatonin) Blood melatonin levels. measured on day two, every two hours for 24 hours beginning at 08:00
Secondary Day-night rhythm in serum glucose Serum glucose levels determined from venous blood draws measured on day two, every two hours for 24 hours beginning at 08:00
Secondary Day-night rhythm in serum insulin Serum insulin levels determined from venous blood draws measured on day two, every two hours for 24 hours beginning at 08:00
Secondary Day-night rhythm in serum free fatty acids (FFA) Serum FFA levels determined from venous blood draws measured on day two, every two hours for 24 hours beginning at 08:00
Secondary Day-night rhythm in serum triglycerides Serum triglyceride levels determined from venous blood draws measured on day two, every two hours for 24 hours beginning at 08:00
Secondary Day-night rhythm in serum cholesterol Serum cholesterol levels determined from venous blood draws measured on day two, every two hours for 24 hours beginning at 08:00
Secondary Change in energy status of the heart between morning and evening 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)
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