NCT01177332

Brief Summary

There is increasing evidence that hepatic lipid content (IntraHepatic Lipid, IHL) markedly increases the risk of metabolic complications, including insulin resistance and cardiovascular events. The investigators hypothesize that the liver is passively taking up free fatty acids (FFA) when the availability is high, thereby leading to an increased storage. To test this hypothesis, the investigators want to manipulate FFA levels, by means of a fasted exercise and recovery protocol, and monitor IHL content and hepatic Adenosine triphosphate (ATP) and inorganic phosphate (Pi) concentrations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable diabetes

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

Study Start

First participant enrolled

April 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

November 11, 2015

Status Verified

November 1, 2015

Enrollment Period

3.2 years

First QC Date

August 2, 2010

Last Update Submit

November 10, 2015

Conditions

DiabetesHepatic Steatosis

Keywords

FFALiversteatosisexercise

Outcome Measures

Primary Outcomes (2)

  • Intrahepatic lipid content (IHL) and hepatic ATP and PI concentrations

    After a baseline MRI/MRS-scan, subjects will cycle for two hours, immediately after cycling another MRI/MRS-scan will be performed and again four hours post exercise. The baseline and the 4-hour post exercise MRI/MRS scans take about 1.5 hour, including both determination of IHL content, by 1H-MRS, and hepatic ATP and Pi concentrations, by 31P-MRS. The MRI/MRS scan performed directly after exercise will take about 45 min, because here only the IHL content will be determined.

    Day 1

  • Intrahepatic lipid content (IHL) and hepatic ATP and PI concentrations

    After a baseline MRI/MRS-scan, subjects will cycle for two hours, immediately after cycling another MRI/MRS-scan will be performed and again four hours post exercise. The baseline and the 4-hour post exercise MRI/MRS scans take about 1.5 hour, including both determination of IHL content, by 1H-MRS, and hepatic ATP and Pi concentrations, by 31P-MRS. The MRI/MRS scan performed directly after exercise will take about 45 min, because here only the IHL content will be determined.

    Day 8

Secondary Outcomes (2)

  • Substrate oxidation and blood plasma levels of FFA, triglycerides, glucose and catecholamines

    Day 1

  • Substrate oxidation and blood plasma levels of FFA, triglycerides, glucose and catecholamines

    Day 8

Study Arms (2)

Fasted

EXPERIMENTAL

Two-hour cycling test, fasted condition

Other: exercise

Glucose-fed

OTHER

Two-hour cycling test, glucose-fed condition

Other: exercise

Interventions

exerciseOTHER

2 hours cycling exercise at 50 % of maximal power output

FastedGlucose-fed

Eligibility Criteria

Age40 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male sex
  • Age 40-65 years
  • Overweight/obese, BMI 25-35 kg/m2
  • Healthy
  • Stable dietary habits
  • No medication use

You may not qualify if:

  • Female sex
  • Fasting plasma glucose \>6.1 mmol/l
  • Haemoglobin \<7.8 mmol/l
  • Engagement in programmed exercise \> 2 hours total per week
  • Elevated liver enzymes: ALAT \> 45 U/L, ASAT \> 35 U/L, ALP\> 140 U/L, Gamma-GT \> 70 U/L
  • Hypertension: blood pressure \> 140 mmHg systolic or 90 mmHg diastolic
  • First degree relatives with history of liver disease and diabetes mellitus
  • Any medical condition requiring treatment and/or medication use
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Biology, Maastricht University

Maastricht, 6200 MD, Netherlands

Location

MeSH Terms

Conditions

Diabetes MellitusFatty LiverMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLiver DiseasesDigestive System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Patrick Schrauwen, Doctor

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 2, 2010

First Posted

August 9, 2010

Study Start

April 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

November 11, 2015

Record last verified: 2015-11

Locations

NL(1)