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Completed

NCT Number: NCT01906333

Elevated FFA and Skeletal Muscle Lipid Content

There is increasing evidence that skeletal muscle lipid content (IntraMyoCellular Lipid, IMCL) markedly increases the risk of metabolic complications, including insulin resistance and cardiovascular events. The investigator hypothesizes that skeletal muscle is passively taking up FFAs when the availability is high, thereby leading to an increased storage. To test this hypothesis, the investigator wants to manipulate FFA levels, by means of exercise, and monitor intramuscular lipid content.

Therefore the objective is to examine the effect of an exercise-induced elevation of FFA on skeletal muscle lipid content in healthy lean men. To this end, skeletal muscle lipid content will be investigated at baseline and after an exercise protocol and again after a four-hour recovery period from exercise, once in a condition with high FFA concentration, once with low FFA concentration. To achieve high- versus low FFA concentrations, an exercise protocol was chosen and participants had to perform this protocol once with a glucose supplementation and once without.

Skeletal muscle lipid content will be determined before, directly after exercise and 4 h post exercise (from muscle biopsies) with or without glucose supplementation.

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Key information

Conditions

Diabetes Behavior Diabetes Mellitus Endocrine System Diseases Exercise Physiology Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Human Biology, Maastricht University Medical Center (MUMC)

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male sex
  • Age 18-30 years
  • Lean, BMI 18-25 kg/m2
  • Healthy
  • Stable dietary habits
  • No medication use

Exclusion criteria

  • Female sex
  • Engagement in programmed exercise > 2 hours total per week
  • Cardiac problems, such as angina pectoris, cardiac infarction and arrhythmias
  • First degree relatives with type 2 diabetes mellitus
  • Any medical condition requiring treatment and/or medication use
  • Unstable body weight (weight gain or loss > 3 kg in the past three months)
  • Participation in other biomedical study within 1 month prior to the screening visit
  • Subjetcs, who do not want to be informed about unexpected medical findings, or do not wish that their treating physician is informed, cannot participate in the study

Treatment and study plan

Exercise

Other

Glucose

Other

Fasted

Other

Primary outcomes

  1. Change in IntraMyoCellularLipid (IMCL)content

    Time frame: Baseline, directly postexercise and 4 hours post-exercise

    A muscle biopsy will be withdrawn before, after 2 hours of exercise and again 4 hours post-exercise for later analysis of IMCL.

Secondary outcomes

  1. Change in substrate metabolism

    Time frame: Measured several time points during the test day

    Substrate metabolism will be measured for 15 min every 30 min of exercise and 20 min every hour of recovery for later analysis of fat- and glucose oxidation.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Effects of Acute Elevation of Circulating Fatty Acids on Skeletal Muscle Lipid Accumulation and Metabolism in Healthy Lean Young Men

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 24, 2013
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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