HealthyNCT00786578
Evaluation of Skeletal Muscle Lipid Content by Magnetic Resonance Spectroscopy
An observational study of Healthy, run by University of Minnesota at 1 site in United States.
Trial summary
Type 2 diabetes is a growing public health issue and one component of Type 2 diabetes is 'insulin resistance" - the ability of insulin to work less well. The skeletal muscle is one of the largest users of sugar in the body, when the skeletal muscle is "insulin resistant", this contributes to diabetes. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jan 2014
- Phase
- Observational
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy subjects on regular running program.
Who may be able to join
- Age range will be from age 18 to 45. We will be limiting the upper age range because increased age is associated with sarcopenia and alteration of fiber type.
- We will define the lean trained group by a BMI of < 24 kg/m2. We will define the overweight group as BMI > 26 25 kg/m2.
- The subjects should be participating in regular running exercise (> 30 min/day, ≥ 5 days/week).
- Weight must be stable [+/- 5 pounds] for at least the three months prior to the study for all participants.
Who cannot join
- The subjects must not be on medications that may affect lipid levels, specifically lipid lowering agents, birth control pills, or diuretics.
- The subjects should not be on a high fat diet (> 45% fat) as measured by a screening questionnaire.
- The subject must not have any contraindications to magnetic resonance imaging.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univeresity of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Evaluation of Intramyocellular Lipid Content (IMCL) in Skeletal Muscle by Magnetic Resonance Spectroscopy
Type 2 diabetes is a growing public health issue and one component of Type 2 diabetes is 'insulin resistance" - the ability of insulin to work less well. The skeletal muscle is one of the largest users of sugar in the body, when the skeletal muscle is "insulin resistant", this contributes to diabetes. There is some evidence that the amount of fat in the skeletal muscle is related to the amount of insulin resistance. We are asking people to participate in a study to look at the amount of fat in muscle and how this fat amount changes with exercise. We hypothesize that heavier people will have higher amounts of fat and deplete this fat more slowly than lean subjects.
Read the detailed description
High intramyocellular lipid (IMCL) content in skeletal muscle has been correlated to insulin resistance in obese subjects. Yet, endurance athletes have high intramyocellular lipid content and very low insulin resistance. There are several explanations for this paradox. This study will use a new magnetic resonance imaging technique to look at the amount of fat in the muscle and its depletion with exercise. We hypothesize that overweight subjects will have higher amounts of fat and deplete this fat more slowly than lean subjects.
- Conditions
- Healthy
- Keywords
- training, intramyocellular lipid, insulin resistance
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | overweight runners (BMI>25) | |
| 2 | lean runners (BMI<24) |
What is being measured
The primary outcome is the main question the study is designed to answer.
absolute change in intramyocellular lipid quantity with exercise
Measured: over 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startJan 2010
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Responsible party
- Sponsor
- Investigators
- Lisa S Chow, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786578
- Sponsor's protocol ID
- 0708M13941
- Other IDs
- 5K12RR023247-02
- Status last verified
- Oct 2014
- First submitted
- 5 Nov 2008
- Last updated
- 24 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intramyocellular Lipid Content (IMCL) in Skeletal Muscle by Magnetic Resonance Spectroscopy
- ClinicalTrials.gov ID
- NCT00786578
- Acronym / sponsor ID
- 0708M13941
- Conditions
- Healthy
- Keywords
- training, intramyocellular lipid, insulin resistance
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Jan 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 6 Nov 2008 (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.
Type 2 diabetes is a growing public health issue and one component of Type 2 diabetes is 'insulin resistance" - the ability of insulin to work less well. The skeletal muscle is one of the largest users of sugar in the body, when the skeletal muscle is "insulin resistant", this contributes to diabetes. There is some evidence that the amount of fat in the skeletal muscle is related to the amount of insulin resistance. We are asking people to participate in a study to look at the amount of fat in muscle and how this fat amount changes with exercise. We hypothesize that heavier people will have higher amounts of fat and deplete this fat more slowly than lean subjects.
Detailed description
High intramyocellular lipid (IMCL) content in skeletal muscle has been correlated to insulin resistance in obese subjects. Yet, endurance athletes have high intramyocellular lipid content and very low insulin resistance. There are several explanations for this paradox. This study will use a new magnetic resonance imaging technique to look at the amount of fat in the muscle and its depletion with exercise. We hypothesize that overweight subjects will have higher amounts of fat and deplete this fat more slowly than lean subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –overweight runners (BMI>25) |
| 2 | – | –lean runners (BMI<24) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy subjects on regular running program.
Key inclusion criteria (4 listed)
- Age range will be from age 18 to 45. We will be limiting the upper age range because increased age is associated with sarcopenia and alteration of fiber type.
- We will define the lean trained group by a BMI of < 24 kg/m2. We will define the overweight group as BMI > 26 25 kg/m2.
- The subjects should be participating in regular running exercise (> 30 min/day, ≥ 5 days/week).
- Weight must be stable [+/- 5 pounds] for at least the three months prior to the study for all participants.
Key exclusion criteria (3 listed)
- The subjects must not be on medications that may affect lipid levels, specifically lipid lowering agents, birth control pills, or diuretics.
- The subjects should not be on a high fat diet (> 45% fat) as measured by a screening questionnaire.
- The subject must not have any contraindications to magnetic resonance imaging.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
absolute change in intramyocellular lipid quantity with exercise
Time frame: over 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2014.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Lisa S Chow principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Minnesota at 1 site in United States.
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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 24 Oct 2014. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
absolute change in intramyocellular lipid quantity with exercise (time frame: over 4 months). 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 24 Oct 2014.