ObesityBATFollowUpNCT01985503
Longitudinal Follow-up of Brown Adipose Tissue Function and Structure
An observational study of Obesity, run by Turku University Hospital at 1 site in Finland.
Trial summary
In Turku PET Centre, there have been 3 positron emission tomography studies on brown adipose tissue (BAT) activity in healthy adults. BATPET was performed between 2008 and 2009. FATBAT started in 2011 and Dixon-BAT in 2012 and they are both currently ongoing. Read more about this study
- Who is it for?
- Ages 22 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 95 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2015to 31 Dec 2017
- How long will I take part?
- 5 Years
- 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 22 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Study subjects are healthy 22-55-year-old Caucasians. Population contains both lean and obese subjects.
Who may be able to join
- All study subjects have been screened prior to acceptance in BATPET, FATBAT and Dixon-BAT studies and no screening for inclusion is required in the current study.
Who cannot join
- 1) Smoking 2) Blood pressure > 160/100 mmHg 3) Pregnancy or lactation 4) Medication (expected effect on study variables)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brown Adipose Tissue: Longitudinal Follow-up of Brown Adipose Tissue Structure and Associations With Obesity and Cardiovascular Risk Factors in Healthy Participants of Baseline PET Studies (BAT-Follow-Up)
In Turku PET Centre, there have been 3 positron emission tomography studies on brown adipose tissue (BAT) activity in healthy adults. BATPET was performed between 2008 and 2009. FATBAT started in 2011 and Dixon-BAT in 2012 and they are both currently ongoing. In the current study, participants of BATPET, FATBAT and Dixon-BAT studies are recruited for a follow-up study to examine associations between obesity, cardiovascular risk factors, serum metabolic profile and BAT structure at baseline and during follow-up several years later. 43 BATPET participants will be called for follow-up in 2013 with a follow-up period of 5 years and 52 FATBAT and Dixon-BAT participants in years 2014 and 2015 with a follow-up period of 3 years. The aim of this study is to examine longitudinal associations between BAT function and structure, liver adiposity and cardiovascular risk factors at baseline and during follow-up.
- Conditions
- Obesity
- Keywords
- positron emission tomography, magnetic resonance imaging, brown adipose tissue, obesity, cardiovascular disease, subclinical atherosclerosis
- Medical subject headings
- Obesity, Cardiovascular Diseases
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 |
|---|---|---|
| Phase 1 group | Subjects were studied in 2009 and their follow-up is in 2014. | |
| Phase 2 group | Subjects were studied in 2011 and their follow-up is in 2016. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between baseline brown adipose tissue activity according to PET imaging and serum lipoprotein concentrations at follow-up 5 years later
Brown adipose tissue activity is determined with FDG-PET imaging at baseline in 43 subjects and 5 years later the subjects participate a follow-up visit where lipoprotein levels are measured in mmol/l from serum samples. Correlation between brown adipose tissue activity and serum lipoproteins are examined with Pearson's correlation.
Measured: 5 years
Secondary outcomes (1)
Association between brown adipose tissue structure at baseline and at follow-up
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startJan 2015
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Juho Raiko, Turku University Hospital
- Investigators
- Juho RH Raiko, MD, PhD, Principal investigator, PET Centre, Turku Univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985503
- Sponsor's protocol ID
- BAT-Follow-Up
- Other IDs
- BATFOLLOWUP
- Acronym
- BATFollowUp
- Status last verified
- May 2019
- First submitted
- 4 Nov 2013
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brown Adipose Tissue: Longitudinal Follow-up of Brown Adipose Tissue Structure and Associations With Obesity and Cardiovascular Risk Factors in Healthy Participants of Baseline PET Studies (BAT-Follow-Up)
- ClinicalTrials.gov ID
- NCT01985503
- Acronym / sponsor ID
- BATFollowUp / BAT-Follow-Up
- Conditions
- Obesity
- Keywords
- positron emission tomography, magnetic resonance imaging, brown adipose tissue, obesity, cardiovascular disease, subclinical atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Jan 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 15 Nov 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.
In Turku PET Centre, there have been 3 positron emission tomography studies on brown adipose tissue (BAT) activity in healthy adults. BATPET was performed between 2008 and 2009. FATBAT started in 2011 and Dixon-BAT in 2012 and they are both currently ongoing. In the current study, participants of BATPET, FATBAT and Dixon-BAT studies are recruited for a follow-up study to examine associations between obesity, cardiovascular risk factors, serum metabolic profile and BAT structure at baseline and during follow-up several years later. 43 BATPET participants will be called for follow-up in 2013 with a follow-up period of 5 years and 52 FATBAT and Dixon-BAT participants in years 2014 and 2015 with a follow-up period of 3 years. The aim of this study is to examine longitudinal associations between BAT function and structure, liver adiposity and cardiovascular risk factors at baseline and during follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 group | – | –Subjects were studied in 2009 and their follow-up is in 2014. |
| Phase 2 group | – | –Subjects were studied in 2011 and their follow-up is in 2016. |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Study subjects are healthy 22-55-year-old Caucasians. Population contains both lean and obese subjects.
Key inclusion criteria (1 listed)
- All study subjects have been screened prior to acceptance in BATPET, FATBAT and Dixon-BAT studies and no screening for inclusion is required in the current study.
Key exclusion criteria (1 listed)
- 1) Smoking 2) Blood pressure > 160/100 mmHg 3) Pregnancy or lactation 4) Medication (expected effect on study variables)
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
Correlation between baseline brown adipose tissue activity according to PET imaging and serum lipoprotein concentrations at follow-up 5 years later
Time frame: 5 years
Brown adipose tissue activity is determined with FDG-PET imaging at baseline in 43 subjects and 5 years later the subjects participate a follow-up visit where lipoprotein levels are measured in mmol/l from serum samples. Correlation between brown adipose tissue activity and serum lipoproteins are examined with Pearson's correlation.
1 secondary outcome
Association between brown adipose tissue structure at baseline and at follow-up
Time frame: 5 years
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 6 May 2019.
Related trials for Obesity
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Recruiting
Confident Moves Intervention Efficacy Trial: Obesity Care Settings
Obesity, Overweight
Not yet recruiting
Stearic Acid and Endothelial Function
Healthy Middle-aged Subjects, Obesity & Overweight
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.
Juho RH Raiko, MD, PhD principal investigator
PET Centre, Turku Univesity
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 Obesity, run by Turku University Hospital at 1 site in Finland.
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 1 inclusion and 1 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 6 May 2019. 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 Finland. 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?
Correlation between baseline brown adipose tissue activity according to PET imaging and serum lipoprotein concentrations at follow-up 5 years later (time frame: 5 years). 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 6 May 2019.