DiabetesNCT01906333
Elevated FFA and Skeletal Muscle Lipid Content
A study testing Exercise, Glucose and Fasted in people with Diabetes and Exercise Physiology, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Exercise Physiology
- What is being tested?
- Exercise, Glucose and Fasted
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2013to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male sex
- Age 18-30 years
- Lean, BMI 18-25 kg/m2
- Healthy
- Stable dietary habits
- No medication use
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Human Biology, Maastricht University Medical Center (MUMC)
Maastricht
About this study
Official title: Effects of Acute Elevation of Circulating Fatty Acids on Skeletal Muscle Lipid Accumulation and Metabolism in Healthy Lean Young Men
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
- Being tested
- Exercise, Glucose, Fasted
- Keywords
- Exercise, Ectopic fat accumulation
- Medical subject headings
- Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
GlucoseOther
FastedOther
| Study group | Role | What they receive |
|---|---|---|
| Exercise & Glucose | Experimental | 2 hour exercise while getting glucose-supplementation Receives: Other: Exercise; Other: Glucose |
| Exercise & Fasted | Experimental | 2 hour exercise while staying fasted Receives: Other: Exercise; Other: Fasted |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, directly postexercise and 4 hours post-exercise
Secondary outcomes (1)
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: Measured several time points during the test day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lena Bilet, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906333
- Sponsor's protocol ID
- NL43302.068.13/METC 13-3-003
- Status last verified
- May 2015
- First submitted
- 16 Jul 2013
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Elevation of Circulating Fatty Acids on Skeletal Muscle Lipid Accumulation and Metabolism in Healthy Lean Young Men
- ClinicalTrials.gov ID
- NCT01906333
- Acronym / sponsor ID
- NL43302.068.13/METC 13-3-003
- Conditions
- Diabetes, Exercise Physiology
- Keywords
- Exercise, Ectopic fat accumulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 24 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise & Glucose | Experimental | Other: Exercise, Other: Glucose2 hour exercise while getting glucose-supplementation |
| Exercise & Fasted | Experimental | Other: Exercise, Other: Fasted2 hour exercise while staying fasted |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male sex
- Age 18-30 years
- Lean, BMI 18-25 kg/m2
- Healthy
- Stable dietary habits
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise | Other | Exercise & Fasted, Exercise & Glucose |
| Glucose | Other | Exercise & Glucose |
| Fasted | Other | Exercise & Fasted |
Primary outcome
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.
1 secondary outcome
Change in substrate metabolism
Time frame: Measured several time points during the test day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Glucose and Fasted in people with Diabetes and Exercise Physiology, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IntraMyoCellularLipid (IMCL)content (time frame: Baseline, directly postexercise and 4 hours post-exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.