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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Netherlands
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maastricht University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Maastricht University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 9, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 20, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 29, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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