Physical ActivityEXEBATNCT03359824
Brown Adipose Tissue Activation: Effect of Exercise Training and Irisin
A study testing Exercise in people with Physical Activity, run by Turku University Hospital.
Trial summary
This study investigates the brown adipose tissue (BAT) activation and metabolism using positron emission tomography (PET) imaging before and after exercise training intervention at fasting state under normal room temperature and during cold stimulation.The investigators hypothesize that BAT glucose uptake is increased… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- 17 Sep 2013to 27 May 2015
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy sedentary volunteer
- BMI 20-25 kg/m2
- Age: 18-45 years
- No chronic diseases
Who cannot join
- BMI < 20 kg/m2 or BMI > 25 kg/m2
- Mental disorder or poor compliance
- Eating disorder or excessive use of alcohol or tobacco smoking
- Any chronic disease
- Past dose of radiation
- Presence of any ferromagnetic objects that would make MR imaging contraindicated
- Physically disability which rule out the physical fitness tests or participation in the exercise training intervention
- Any other condition that in the opinion of the investigator could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
About this study
This study investigates the brown adipose tissue (BAT) activation and metabolism using positron emission tomography (PET) imaging before and after exercise training intervention at fasting state under normal room temperature and during cold stimulation.The investigators hypothesize that BAT glucose uptake is increased after exercise and BAT becomes metabolically more active.
Understanding the mechanisms of BAT activation and the role of exercise in humans is crucial to combat epidemic of obesity and diabetes.
Read the detailed description
Exercise training has been suggested to activate and recruit human BAT through the activation of sympathetic nervous system and contracting skeletal muscles by the release of myokines such as lactate and irisin that signal WAT to induce expression of beige adipocytes. It has been also suggested that exercise training could enhance the metabolism of already existed functional BAT by increasing uncoupling protein-1 (UCP-1) gene transcription, mitochondrial biogenesis and hyperplasia. This is of clinical relevance because brown fat activation has been found to improve metabolic factors linked to obesity and diabetes.
In this study the investigators use a PET radiotracer 2-[18F] flouro-2-deoxy-D-glucose (FDG) to quantify the glucose uptake in BAT, whie adipose tissue and the muscle.The participants are scanned thrice at fast in this study once at room temperature, second at cold exposure and third after six weeks of exercise at cold exposure. This study will provide an insight about the role of exercise in activation of BAT metabolism.
- Conditions
- Physical Activity
- Being tested
- Exercise
- Keywords
- exercise, brown adipose tissue
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Other | Arm: Exercise: Combination of moderate intensity continuous training, high intensity interval training and endurance training 5 times per week for a total of 6 weeks. Out of 5 sessions three were supervised by trainer and two sessions were performed by subjects on their own.The duration of the exercise was increased progressively. The first two weeks was 30 minutes that increased to 45 minutes in the third and fourth week. It was 60 minutes for the last two weeks. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cold-induced glucose uptake in BAT after exercise
Glucose uptake of brown adipose tissue acquired with PET under cold exposure after exercise intervention. PET imaging is used to quantify glucose uptake in tissues
Measured: Within one study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start17 Sep 2013
- Primary completion27 May 2015
- Study completion27 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Pirjo Nuutila, Turku University Hospital
- Investigators
- Pirjo Nuutila, MD, PhD, Principal investigator, Turku UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359824
- Sponsor's protocol ID
- EXEBAT
- Acronym
- EXEBAT
- Status last verified
- Jan 2019
- First submitted
- 27 Nov 2017
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brown Adipose Tissue Activation: Effect of Exercise Training and Irisin
- ClinicalTrials.gov ID
- NCT03359824
- Acronym / sponsor ID
- EXEBAT / EXEBAT
- Conditions
- Physical Activity
- Keywords
- exercise, brown adipose tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 17 Sep 2013 (actual)
- Primary completion
- 27 May 2015 (actual)
- Study completion
- 27 May 2015 (actual)
- First posted
- 2 Dec 2017 (actual)
- 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.
This study investigates the brown adipose tissue (BAT) activation and metabolism using positron emission tomography (PET) imaging before and after exercise training intervention at fasting state under normal room temperature and during cold stimulation.The investigators hypothesize that BAT glucose uptake is increased after exercise and BAT becomes metabolically more active.
Understanding the mechanisms of BAT activation and the role of exercise in humans is crucial to combat epidemic of obesity and diabetes.
Detailed description
Exercise training has been suggested to activate and recruit human BAT through the activation of sympathetic nervous system and contracting skeletal muscles by the release of myokines such as lactate and irisin that signal WAT to induce expression of beige adipocytes. It has been also suggested that exercise training could enhance the metabolism of already existed functional BAT by increasing uncoupling protein-1 (UCP-1) gene transcription, mitochondrial biogenesis and hyperplasia. This is of clinical relevance because brown fat activation has been found to improve metabolic factors linked to obesity and diabetes.
In this study the investigators use a PET radiotracer 2-[18F] flouro-2-deoxy-D-glucose (FDG) to quantify the glucose uptake in BAT, whie adipose tissue and the muscle.The participants are scanned thrice at fast in this study once at room temperature, second at cold exposure and third after six weeks of exercise at cold exposure. This study will provide an insight about the role of exercise in activation of BAT metabolism.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Other | Other: ExerciseArm: Exercise: Combination of moderate intensity continuous training, high intensity interval training and endurance training 5 times per week for a total of 6 weeks. Out of 5 sessions three were supervised by trainer and two sessions were performed by subjects on their own.The duration of the exercise was increased progressively. The first two weeks was 30 minutes that increased to 45 minutes in the third and fourth week. It was 60 minutes for the last two weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy sedentary volunteer
Key exclusion criteria (8 listed)
- BMI < 20 kg/m2 or BMI > 25 kg/m2
- Mental disorder or poor compliance
- Eating disorder or excessive use of alcohol or tobacco smoking
- Any chronic disease
- Past dose of radiation
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 |
Primary outcome
Cold-induced glucose uptake in BAT after exercise
Time frame: Within one study day
Glucose uptake of brown adipose tissue acquired with PET under cold exposure after exercise intervention. PET imaging is used to quantify glucose uptake in tissues
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 22 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Pirjo Nuutila, MD, PhD principal investigator
Turku UH
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Physical Activity, run by Turku University Hospital.
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 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 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Cold-induced glucose uptake in BAT after exercise (time frame: Within one study day). 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 22 Jan 2019.