Liver FatEXITNCT02204670
EXIT: Prospective Study of the Response to Exercise
An observational study of Liver Fat and Type 2 Diabetes, run by University of Manitoba at 1 site in Canada.
Trial summary
Background : Regular exercise is a cornerstone in the prevention and the management of comorbidities. Unfortunately, the metabolic benefit of exercise training is not universal and varies among individuals. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Fat, Type 2 Diabetes
- What is being tested?
- Acute release of irisin after a single exercise session.
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to Oct 2015
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: A community-based convenient sample of overweight adolescents aged 12-18 years with a BMI > 95th centile for age and sex.
Who may be able to join
- Adolescents (12-18 years)
- Body mass index considered obese according to the International Obesity Task Force
Who cannot join
- Adolescents with medication-induced or type 1 diabetes
- are currently being treated with corticosteroids or atypical antipsychotics, as these agents significantly influence carbohydrate metabolism
- have an orthopaedic injury or chronic illness that would prevent them from performing the intervention
- have experienced >10% weight loss or enrolled in weight loss program within six months of enrolment
- a history of alcoholism or drug abuse
- require use of medication(s) known to affect insulin sensitivity or secretion within the last 30 days
Show all 10Show fewer
- medication(s) known to cause weight gain
- anabolic steroids
- weight loss medication(s)
- pregnant or planning to be pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise and Irisin Trial (EXIT): Prospective Cohort Study of the Determinants of the Metabolic Response to Exercise in Obese Adolescents
Background :
Regular exercise is a cornerstone in the prevention and the management of comorbidities. Unfortunately, the metabolic benefit of exercise training is not universal and varies among individuals. A main factor likely to explain the exercise training variability is the lack of empirical evidence on the determinants of exercise training. A series of muscle-derived cytokines have recently been discovered that (1) are released during exercise and (2) exert positive effects on peripheral tissues. Irisin is one of these novel "myokines" and might contributes to the metabolic adaptations to exercise training.
Read more
Methods:
The investigators will perform a pilot cohort study in which obese adolescents will perform resistance exercise training for 6 weeks. The main exposure variable will be the acute release of irisin during resistance exercise. The main outcome measures will be the change in hepatic triglyceride content and glucose area under the curve during a 75g, 2-hour oral glucose tolerance test.
Study Hypothesis:
The primary overall hypothesis is that the change in plasma Irisin with a single bout of exercise will be associated with the metabolic adaptations to 6 weeks of resistance training, specifically, the reductions in hepatic triglyceride content and post-prandial glucose excursions, in obese adolescents.
- Conditions
- Liver Fat, Type 2 Diabetes
- Being tested
- Acute release of irisin after a single exercise session.
- Keywords
- Irisin, Obesity, Exercise, Myokine, Impaired Glucose Tolerance
- Medical subject headings
- Fatty Liver, Diabetes Mellitus, Type 2, Obesity, Motor Activity, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute release of irisin after a single exercise session.Other
We will determine the amount of Irisin secreted after a single bout of resistance exercise. Participants will be stratified into 3 groups based on the degree of Irisin release during this acute bout of resistance exercise. The metabolic adaptations to the 4 weeks of resistance training will be compared between youth stratified according to the amount of Irisin released during the acute bout of resistance exercise.
| Study group | Role | What they receive |
|---|---|---|
| Overweight Adolescents Performing Resistance Training | Overweight adolescents that meet pre-specified enrollment criteria will all undergo supervised resistance exercise for a 6-week period. Prior to training, all participants will undergo a single bout of resistance training to determine the acute release of Irisin with resistance training. This will be the primary exposure variable. After the acute session, all participants will perform resistance training three times per week for a period of 4 weeks. During each session participants will perform 3 sets of 8-12 repetitions (60-85% of 1RM) for major muscle groups (quadriceps, shoulders, and pectoral). Receives: Other: Acute release of irisin after a single exercise session. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic Triglyceride Content
Hepatic triglyceride content will be measured by using 1H magnetic resonance spectroscopy. After image acquisition, a single voxel volume of interest will be placed in the upper right lobe of the liver in an area devoid of adipose tissue to acquire 1H spectra. A total of 64 spectra will be collected and averaged to determine the intracellular triglyceride content.
Measured: 6 weeks
Secondary outcomes (1)
Post-prandial glucose
Glucose area under the curve (AUC) will be determined by summing the area under serum glucose measures between each 15- or 30-min segment using the trapezium rule during a frequently sampled 75-g oral glucose challenge .
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FatStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jon McGavock, University of Manitoba
- Investigators
- Jon M McGavock, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204670
- Sponsor's protocol ID
- B2014:064
- Acronym
- EXIT
- Status last verified
- Mar 2016
- First submitted
- 28 Jul 2014
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Irisin Trial (EXIT): Prospective Cohort Study of the Determinants of the Metabolic Response to Exercise in Obese Adolescents
- ClinicalTrials.gov ID
- NCT02204670
- Acronym / sponsor ID
- EXIT / B2014:064
- Conditions
- Liver Fat, Type 2 Diabetes
- Keywords
- Irisin, Obesity, Exercise, Myokine, Impaired Glucose Tolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 30 Jul 2014 (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.
Background :
Regular exercise is a cornerstone in the prevention and the management of comorbidities. Unfortunately, the metabolic benefit of exercise training is not universal and varies among individuals. A main factor likely to explain the exercise training variability is the lack of empirical evidence on the determinants of exercise training. A series of muscle-derived cytokines have recently been discovered that (1) are released during exercise and (2) exert positive effects on peripheral tissues. Irisin is one of these novel "myokines" and might contributes to the metabolic adaptations to exercise training.
Methods:
The investigators will perform a pilot cohort study in which obese adolescents will perform resistance exercise training for 6 weeks. The main exposure variable will be the acute release of irisin during resistance exercise. The main outcome measures will be the change in hepatic triglyceride content and glucose area under the curve during a 75g, 2-hour oral glucose tolerance test.
Study Hypothesis:
The primary overall hypothesis is that the change in plasma Irisin with a single bout of exercise will be associated with the metabolic adaptations to 6 weeks of resistance training, specifically, the reductions in hepatic triglyceride content and post-prandial glucose excursions, in obese adolescents.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overweight Adolescents Performing Resistance Training | – | Other: Acute release of irisin after a single exercise session.Overweight adolescents that meet pre-specified enrollment criteria will all undergo supervised resistance exercise for a 6-week period. Prior to training, all participants will undergo a single bout of resistance training to determine the acute release of Irisin with resistance training. This will be the primary exposure variable. After the acute session, all participants will perform resistance training three times per week for a period of 4 weeks. During each session participants will perform 3 sets of 8-12 repetitions (60-85% of 1RM) for major muscle groups (quadriceps, shoulders, and pectoral). |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- A community-based convenient sample of overweight adolescents aged 12-18 years with a BMI > 95th centile for age and sex.
Key inclusion criteria (2 listed)
- Adolescents (12-18 years)
- Body mass index considered obese according to the International Obesity Task Force
Key exclusion criteria (10 listed)
- Adolescents with medication-induced or type 1 diabetes
- are currently being treated with corticosteroids or atypical antipsychotics, as these agents significantly influence carbohydrate metabolism
- have an orthopaedic injury or chronic illness that would prevent them from performing the intervention
- have experienced >10% weight loss or enrolled in weight loss program within six months of enrolment
- a history of alcoholism or drug abuse
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 |
|---|---|---|
| Acute release of irisin after a single exercise session.We will determine the amount of Irisin secreted after a single bout of resistance exercise. Participants will be stratified into 3 groups based on the degree of Irisin release during this acute bout of resistance exercise. The metabolic adaptations to the 4 weeks of resistance training will be compared between youth stratified according to the amount of Irisin released during the acute bout of resistance exercise. | Other | Overweight Adolescents Performing Resistance Training |
Primary outcome
Hepatic Triglyceride Content
Time frame: 6 weeks
Hepatic triglyceride content will be measured by using 1H magnetic resonance spectroscopy. After image acquisition, a single voxel volume of interest will be placed in the upper right lobe of the liver in an area devoid of adipose tissue to acquire 1H spectra. A total of 64 spectra will be collected and averaged to determine the intracellular triglyceride content.
1 secondary outcome
Post-prandial glucose
Time frame: 6 weeks
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 31 Mar 2016.
Related trials for Liver Fat
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
The Effects of Glucagon on Hepatic Metabolism in People With Type 2 Diabetes After Caloric Restriction
Type2diabetes
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)
Not yet recruitingPhase 2
Qurse Revand for MASLD: A Randomized Controlled Safety and Efficacy Trial
MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Rupatadine in the Treatment of Nonalcoholic Fatty Liver Disease Patients.
NAFLD (Nonalcoholic Fatty Liver Disease)
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.
Jon M McGavock, PhD principal investigator
University of Manitoba
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 Liver Fat and Type 2 Diabetes, run by University of Manitoba at 1 site in Canada.
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 2 inclusion and 10 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 31 Mar 2016. 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 Canada. 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?
Hepatic Triglyceride Content (time frame: 6 weeks). 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 31 Mar 2016.