Morbid ObesityBARIBRAINNCT04343469
Effects of Morbid Obesity and Bariatric Surgery on Brain Inflammation, and Activation of Central Reward System
A study testing Bariatric Surgery (RYGB or LSG) in people with Morbid Obesity, run by Turku University Hospital at 2 sites in Finland.
Trial summary
Background: The investigators have found that obesity and insulin resistance result in significantly increased brain insulin-stimulated glucose uptake, whereas in every other tissue glucose uptake is lower in the obese compared to lean individuals. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Bariatric Surgery (RYGB or LSG)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesFinland
- Study dates
- 11 Feb 2019to Sep 2022
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18-27 kg/m2
- Fasting plasma glucose ≤6.1 mmol/L
- Normal values in 2-hour oral glucose tolerance test
Who cannot join
- Metal objects in the body (including pacemakers, metallic artificial valve prostheses, inner ear implants, surgical clips, braces, foreign fragments)
- Previous participation in PET studies
- Pregnancy
- Poor compliance, alcohol or drug abuse
- Weight over 150 kg or waist circumference over 150 cm
- Diabetes with fasting glucose levels ≥7.0 mmol/L, or treatment with insulin
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- Any chronic disease, medication or condition that could create a hazard to subject safety, endanger study procedures or interfere with the interpretation of results.
- For the lean control subjects:
- Metal objects in the body (including pacemakers, metallic artificial valve prostheses, inner ear implants, surgical clips, braces, foreign fragments)
- Previous participation in PET studies
- Pregnancy
- Poor compliance, alcohol or drug abuse
- Smoking
- History of eating disorders, drastic weight-gain or weight-loss
- History of psychiatric disorders
- Any chronic disease, medication or condition that could create a hazard to subject safety, endanger study procedures or interfere with the interpretation of results
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Turku PET Centre
Turku, 20520
Turku University Hospital
Turku, 20520
About this study
Official title: Effects of Morbid Obesity and Bariatric Surgery on Brain Inflammation, Insulin Resistance and Activation of Central Reward System Studied Using PET- and MRI-imaging
Background: The investigators have found that obesity and insulin resistance result in significantly increased brain insulin-stimulated glucose uptake, whereas in every other tissue glucose uptake is lower in the obese compared to lean individuals. One possible explanation to this could be central inflammation and activation of brain glial cells, which has been shown to occur in animal models of obesity.
Aims: The objective of this study is to investigate whether there is brain inflammation in human obesity, and whether weight loss following bariatric surgery decreases brain inflammation.
Methods: A total of 60 morbidly obese subjects, assigned for Roux-en-Y gastric bypass or for sleeve gastrectomy according to routine treatment protocols will be recruited for this study. A control group of 30 healthy subjects will also be recruited. The following studies will be performed to patients and healthy subjects: 1) structural MRI and MRS, 2) functional MRI, 3) PET imaging of cerebral inflammation and astrocyte activation using [11C]-PK11195, 4) measurement of whole-body and tissue insulin sensitivity by combining hyperinsulinemic, euglycemic clamp with [18F]-FDG-PET, 5) neuropsychological testing. The study procedures will be repeated for the morbidly obese 6 months postoperatively.
Read the detailed description
This is a prospective study, where subjects for the morbidly obese group (N=60) will be recruited from the patients undergoing bariatric surgery according to normal treatment protocol and the bariatric procedure is decided on clinical data together with the bariatric surgeon and the patient. The morbidly obese patients are studied before and 6 months after bariatric surgery.
Results of obese are compared to results of healthy subjects (N=30), who are studied once.
MRI studies: Brain structural MRI and MRS Structural brain MRI will be performed to obtain anatomical reference. The MR part of a 3T PET-MR system will be used for the study . MR spectroscopy (MRS) will be used to determine levels of different metabolites.Brain activation studies (functional MRI) The aim of the fMRI is to assess how morbid obesity and weight loss influence the brain reward system in response to visual cues (not food related); resting state fMRI will also be performed.
Brain inflammation: [¹¹C]-PK11195 tracer with PET/CT is used to determine activation of glial cells, or inflammation, in the brain. After intravenous injection of 500 MBq [¹¹C]-PK11195, a 60-minute dynamic scan on the brain using the same PET/CT cameras will be performed. Both ROI- and SPM based statistics will be used in the statistical analyses.
Whole-body scan with [18F]-FDG and PET/CT during euglycemic hyperinsulinemia used to promote tissue glucose uptake and measure insulin sensitivity. After 60 minutes from the start of clamp, the subjects will be injected intravenously with 150 MBq of [18F]-fluorodeoxyglucose ([18F]-FDG) Thereafter [18F]-fluorodeoxyglucose uptake in the brain, abdomen, femoral region will be measured.
- Conditions
- Morbid Obesity
- Being tested
- Bariatric Surgery (RYGB or LSG)
- Keywords
- positron emission tomography, magnetic resonance imaging, euglycaemic hyperinsulinemic clamp, astrogliosis, central inflammation, bariatric surgery
- Medical subject headings
- Obesity, Morbid, Gliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric Surgery (RYGB or LSG)Procedure or surgery
Morbidly obese subjects will receive either RYGB or LSG, and the effect of bariatric surgery-induced weight loss on brain inflammation will be assessed
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery | Active comparator | The effect of bariatric surgery (RYGB or LSG) on central inflammation Receives: Procedure: Bariatric Surgery (RYGB or LSG) |
| No intervention | No intervention | Healthy lean volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obese have brain inflammation compared to healthy ones
Brain PET-[11C]-PK11195 imaging study of obese and healthy lean ones
Measured: Both groups at baseline
Bariatric surgery decreases brain inflammation in obesity
PK11195 imaging results are compared before and 6 months after bariatric surgery in obese group studied before and after bariatric surgery
Measured: Baseline and 6 months after operation (obese group only)
Secondary outcomes (6)
Tissue-specific and whole-body insulin sensitivity are decreased in obese
Glucose uptakes are measured using PET imaging in obese and leans
Measured: Baseline obese and leans
Tissue-specific and whole-body glucose improves after bariatric surgery
Comparison before and 6 months after surgery (obese group)
Measured: PET imaging studies at baseline and 6 months after operation
Brain neural activity decreased in obesity
Comparison between obese and lean ones using fMRI
Measured: Baseline obese and leans
Brain neural activity improves after bariatric surgery
Comparison between obese baseline and 6 months after operation
Measured: Baseline and 6 months after operation (obese group)
Brain metabolite concentrations are different in obese
MRS studies for obese and lean ones at baseline are compared
Measured: Baseline obese and leans
Brain metabolite concentrations normalize after bariatric surgery
MRS studies for obese before and 6 months postop compared
Measured: Baseline and 6 months postop (obese group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start11 Feb 2019
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Obese and healthy ones are compared at baseline and obese are compered to healthy ones 6 months after bariatric surgery.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
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
- NCT04343469
- Sponsor's protocol ID
- T26/2019
- Acronym
- BARIBRAIN
- Status last verified
- Oct 2021
- First submitted
- 7 Oct 2019
- Last updated
- 13 Oct 2021
- 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 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Morbid Obesity and Bariatric Surgery on Brain Inflammation, Insulin Resistance and Activation of Central Reward System Studied Using PET- and MRI-imaging
- ClinicalTrials.gov ID
- NCT04343469
- Acronym / sponsor ID
- BARIBRAIN / T26/2019
- Conditions
- Morbid Obesity
- Keywords
- positron emission tomography, magnetic resonance imaging, euglycaemic hyperinsulinemic clamp, astrogliosis, central inflammation, bariatric surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 13 Apr 2020 (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.
Background: The investigators have found that obesity and insulin resistance result in significantly increased brain insulin-stimulated glucose uptake, whereas in every other tissue glucose uptake is lower in the obese compared to lean individuals. One possible explanation to this could be central inflammation and activation of brain glial cells, which has been shown to occur in animal models of obesity.
Aims: The objective of this study is to investigate whether there is brain inflammation in human obesity, and whether weight loss following bariatric surgery decreases brain inflammation.
Methods: A total of 60 morbidly obese subjects, assigned for Roux-en-Y gastric bypass or for sleeve gastrectomy according to routine treatment protocols will be recruited for this study. A control group of 30 healthy subjects will also be recruited. The following studies will be performed to patients and healthy subjects: 1) structural MRI and MRS, 2) functional MRI, 3) PET imaging of cerebral inflammation and astrocyte activation using [11C]-PK11195, 4) measurement of whole-body and tissue insulin sensitivity by combining hyperinsulinemic, euglycemic clamp with [18F]-FDG-PET, 5) neuropsychological testing. The study procedures will be repeated for the morbidly obese 6 months postoperatively.
Detailed description
This is a prospective study, where subjects for the morbidly obese group (N=60) will be recruited from the patients undergoing bariatric surgery according to normal treatment protocol and the bariatric procedure is decided on clinical data together with the bariatric surgeon and the patient. The morbidly obese patients are studied before and 6 months after bariatric surgery.
Results of obese are compared to results of healthy subjects (N=30), who are studied once.
MRI studies: Brain structural MRI and MRS Structural brain MRI will be performed to obtain anatomical reference. The MR part of a 3T PET-MR system will be used for the study . MR spectroscopy (MRS) will be used to determine levels of different metabolites.Brain activation studies (functional MRI) The aim of the fMRI is to assess how morbid obesity and weight loss influence the brain reward system in response to visual cues (not food related); resting state fMRI will also be performed.
Brain inflammation: [¹¹C]-PK11195 tracer with PET/CT is used to determine activation of glial cells, or inflammation, in the brain. After intravenous injection of 500 MBq [¹¹C]-PK11195, a 60-minute dynamic scan on the brain using the same PET/CT cameras will be performed. Both ROI- and SPM based statistics will be used in the statistical analyses.
Whole-body scan with [18F]-FDG and PET/CT during euglycemic hyperinsulinemia used to promote tissue glucose uptake and measure insulin sensitivity. After 60 minutes from the start of clamp, the subjects will be injected intravenously with 150 MBq of [18F]-fluorodeoxyglucose ([18F]-FDG) Thereafter [18F]-fluorodeoxyglucose uptake in the brain, abdomen, femoral region will be measured.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Obese and healthy ones are compared at baseline and obese are compered to healthy ones 6 months after bariatric surgery.
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery | Active comparator | Procedure: Bariatric Surgery (RYGB or LSG)The effect of bariatric surgery (RYGB or LSG) on central inflammation |
| No intervention | No intervention | –Healthy lean volunteers |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI 18-27 kg/m2
- Fasting plasma glucose ≤6.1 mmol/L
- Normal values in 2-hour oral glucose tolerance test
Key exclusion criteria (16 listed)
- Metal objects in the body (including pacemakers, metallic artificial valve prostheses, inner ear implants, surgical clips, braces, foreign fragments)
- Previous participation in PET studies
- Pregnancy
- Poor compliance, alcohol or drug abuse
- Weight over 150 kg or waist circumference over 150 cm
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 |
|---|---|---|
| Bariatric Surgery (RYGB or LSG)Morbidly obese subjects will receive either RYGB or LSG, and the effect of bariatric surgery-induced weight loss on brain inflammation will be assessed | Procedure or surgery | Bariatric surgery |
Primary outcome
Obese have brain inflammation compared to healthy ones
Time frame: Both groups at baseline
Brain PET-[11C]-PK11195 imaging study of obese and healthy lean ones
Bariatric surgery decreases brain inflammation in obesity
Time frame: Baseline and 6 months after operation (obese group only)
PK11195 imaging results are compared before and 6 months after bariatric surgery in obese group studied before and after bariatric surgery
6 secondary outcomes
Tissue-specific and whole-body insulin sensitivity are decreased in obese
Time frame: Baseline obese and leans
Tissue-specific and whole-body glucose improves after bariatric surgery
Time frame: PET imaging studies at baseline and 6 months after operation
Brain neural activity decreased in obesity
Time frame: Baseline obese and leans
Brain neural activity improves after bariatric surgery
Time frame: Baseline and 6 months after operation (obese group)
Brain metabolite concentrations are different in obese
Time frame: Baseline obese and leans
Brain metabolite concentrations normalize after bariatric surgery
Time frame: Baseline and 6 months postop (obese group)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric Surgery (RYGB or LSG) in people with Morbid Obesity, run by Turku University Hospital at 2 sites 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 3 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
Obese have brain inflammation compared to healthy ones (time frame: Both groups at baseline). The study lists 2 primary outcomes in all. 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 13 Oct 2021.