NCT01553968

Brief Summary

It has been suggested that imbalance between TCA-cycle flux and β-oxidation may underlie insulin resistance, a predisposing factor for the development of type 2 diabetes mellitus. Acetylcarnitine concentration is suggested to be a marker of such imbalance. It is expected that when TCA-cycle capacity is high (a high oxidative capacity), less acetylcarnitine will accumulate, because of an improved balance between supply and demand of lipids. The major research objective is to examine if acute exercise results in a more pronounced increase in acetylcarnitine concentration in sedentary subjects compared to endurance-trained subjects and if the exercise-induced increase in acetylcarnitine is restored more quickly in endurance-trained subjects when compared to sedentary subjects. The investigators hypothesize that the increase in acetylcarnitine levels will be lower in trained subjects when compared to sedentary subjects, due to a better balance between lipid supply and utilization by the TCA-cycle. Furthermore it is expected that acetylcarnitine concentrations will be restored faster in these trained subjects, because of a tighter regulation of influx of fatty acids. To test this hypothesis the investigators want to compare the acetylcarnitine response to exercise in a group of sedentary subjects and a group of endurance trained subjects. This response will be measured for 30 minutes after exercise with the use of 1H-MRS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
18 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

September 20, 2016

Status Verified

July 1, 2012

Enrollment Period

1.9 years

First QC Date

March 7, 2012

Last Update Submit

September 19, 2016

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Exercise-induced changes in acetylcarnitine concentrations and dynamics of acetylcarnitine restoration after exercise

    Acetylcarnitine concentration measured with Proton Magnetic Resonance Spectroscopy (1H-MRS)

    During 30 minutes prior to the exercise and for 30 minutes after exercise

Secondary Outcomes (4)

  • Substrate oxidation

    Measured during the 30 minutes of exercise

  • Blood plasma free fatty acids

    At the start and at the end of 30 minutes of exercise

  • Blood plasma triglycerides

    At the start and at the end of 30 minutes of exercise

  • Blood plasma glucose

    At the start and at the end of 30 minutes of exercise

Study Arms (2)

Endurance Trained Subjects

OTHER
Other: Cycling

Untrained Subjects

OTHER
Other: Cycling

Interventions

CyclingOTHER

30 minutes of cycling at 50% of predetermined maximal performance

Endurance Trained SubjectsUntrained Subjects

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal weight (BMI 18-25 kg/m2)
  • Healthy
  • Stable dietary habits
  • No use of medication
  • VO2-max for trained subjects above 50 mL/min/kg
  • VO2-max for untrained subjects below 40 mL/min/kg

You may not qualify if:

  • Any medical condition requiring treatment and/or medication use OR diminishing exercise tolerance
  • Alcohol consumption of more than 20 g per day (± 2 units)
  • Unstable body weight (weight gain or loss \> 3 kg in the past three months)
  • Participation in another biomedical study within 1 month prior to the screening visit
  • Contraindications for MRI scan:
  • Central nervous system aneurysm clips
  • Implanted neural stimulator
  • Implanted cardiac pacemaker of defibrillator
  • Cochlear implant
  • Iron- containing corpora aliena in the eye or brain
  • Hearing aids and artificial (heart) valves which is contraindicated for MRS
  • Subjects, who do not want to be informed about unexpected medical findings cannot participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6202 AZ, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Vera B. Schrauwen-Hinderling, PhD.

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2012

First Posted

March 14, 2012

Study Start

April 1, 2012

Primary Completion

March 1, 2014

Study Completion

June 1, 2014

Last Updated

September 20, 2016

Record last verified: 2012-07

Locations

NL(1)