Elevated FFA and Skeletal Muscle Lipid Content

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01906333
• Other study ID #: NL43302.068.13/METC 13-3-003
• Status: Completed
• Phase: N/A
• First received: July 16, 2013
• Last updated: May 27, 2015
• Start date: May 2013
• Est. completion date: August 2013

Study information

• Verified date: May 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes
• Exercise Physiology

Intervention

Other:
• Exercise

• Glucose

• Fasted

Locations

Country	Name	City	State
Netherlands	Department of Human Biology, Maastricht University Medical Center (MUMC)	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in substrate metabolism	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.	Measured several time points during the test day	No