Elevated FFA and Skeletal Muscle Lipid Content

NCT01906333 | Completed DMC

• 1 other identifier: NL43302.068.13/METC 13-3-003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Exercise Physiology

Keywords

Exercise; Ectopic fat accumulation

Outcome Measures

Primary Outcomes (1)

• Change in IntraMyoCellularLipid (IMCL)content

  A muscle biopsy will be withdrawn before, after 2 hours of exercise and again 4 hours post-exercise for later analysis of IMCL.

  Baseline, directly postexercise and 4 hours post-exercise

Secondary Outcomes (1)

• Change in substrate metabolism

  Measured several time points during the test day

Study Arms (2)

Exercise & Glucose

EXPERIMENTAL

2 hour exercise while getting glucose-supplementation

Other: Exercise; Other: Glucose

Exercise & Fasted

EXPERIMENTAL

2 hour exercise while staying fasted

Other: Exercise; Other: Fasted

Interventions

Exercise OTHER

Exercise & Fasted; Exercise & Glucose

Glucose OTHER

Exercise & Glucose

Fasted OTHER

Exercise & Fasted

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

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

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus; Motor Activity

Interventions

Exercise; Glucose

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: July 16, 2013
• First Posted: July 24, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

NL (1)