Obesity, MorbidBariBrainPETNCT05080205
Effects of Morbid Obesity and Bariatric Surgery on Brain Inflammation, Insulin Resistance and Central Reward System
A study testing Bariatric surgery in people with Obesity, Morbid and Insulin Resistance, run by Turku University Hospital at 1 site in Finland.
Trial summary
Background: Morbid obesity is associated with decreased brain µ-opioid receptor availability, possibly resulting in higher food intake needed to gain pleasure from eating. This decrease seems to normalize already 6 months after bariatric surgery, but the longer-term effects have not been studied. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid, Insulin Resistance
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 11 Feb 2019to Dec 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
- Morbidly obese group
- BMI 35.0-45.0 kg/m2, or BMI 32.0-45.0 kg/m2 and diagnosed diabetes
- Age 18-60 years
- Eligible to bariatric surgery evaluated according to normal treatment paradigm
- Non-obese controls
- BMI 18-27 kg/m2
Show all 9Show fewer
- Age 18-60 years
- Fasting plasma glucose ≤6.1 mmol/L
- Normal values in 2-hour oral glucose tolerance test
Who cannot join
- Morbidly obese group
- Metal objects in the body (including pacemakers, metallic artificial valve prostheses, inner ear implants, surgical clipses, 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
Show all 17Show fewer
- Diabetes with fasting glucose levels ≥7.0 mmol/L, or treatment with insulin
- Any chronic disease, medication or condition that could create a hazard to subject safety, endanger study procedures or interfere with the interpretation of results.
- Non-obese controls
- Metal objects in the body (including pacemakers, metallic artificial valve prostheses, inner ear implants, surgical clipses, 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
1 site in 1 country.
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: Morbid obesity is associated with decreased brain µ-opioid receptor availability, possibly resulting in higher food intake needed to gain pleasure from eating. This decrease seems to normalize already 6 months after bariatric surgery, but the longer-term effects have not been studied. Obesity and insulin resistance result in significantly increased brain insulin-stimulated glucose uptake, whereas in every other tissue glucose uptake is lower. 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. Obesity has also been shown to associate with increased risk of Alzheimer's disease and cognitive decline in several studies.
Aims: The first objective of this study is to both study the effects of bariatric surgery as well as compare the effects of gastric bypass and sleeve gastrectomy on food-associated pleasure, extending the follow-up period to 2 years postoperatively. The second aim is to investigate the effect of morbid obesity and weight loss on brain inflammation and gliosis and its association with increased brain insulin-stimulated glucose uptake. Furthermore, association of obesity, insulin resistance, central inflammation and neurocognitive dysfunction are evaluated.
Read the detailed description
Methods: A total of 60 morbidly obese subjects, 30 assigned for Roux-en-Y gastric bypass and 30 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. We will perform 1) structural MRI and MRS, 2) functional MRI during tasting and visual food cues, 3) PET imaging of µ-opioid receptor availability using [11C]-carfentanil, 4) PET imaging of cerebral inflammation and astrocyte activation using [11C]-PK11195, 5) measurement of whole-body and tissue insulin sensitivity by combining hyperinsulinemic, euglycemic clamp with [18F]-FDG-PET, 6) neuropsychological testing. The control group will only be studied once, whereas study procedures will be repeated for the morbidly obese before very-low calorie diet and 6, 12 and 24 months postoperatively.
- Conditions
- Obesity, Morbid, Insulin Resistance
- Being tested
- Bariatric surgery
- Keywords
- obesity, insulin resistance, central nervous system inflammation, bariatric surgery
- Medical subject headings
- Obesity, Morbid, Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Also called Roux-en-Y gastric bypass, Sleeve gastrectomy
Roux-en-Y gastric bypass or sleeve gastrectomy, chosen based on routine evaluation process
| Study group | Role | What they receive |
|---|---|---|
| Morbidly obese subjects | Experimental | Bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy) Receives: Procedure: Bariatric surgery |
| Control subjects | No intervention | Non-obese controls are only studied at baseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in central inflammation
Assessment of brain glial cell activation using [11C]-PK11195 tracer and positron emission tomography
Measured: Controls: 0 months; Morbidly obese: preoperatively, 6 months postoperatively
Secondary outcomes (5)
Changes in central reward system using fMRI imaging
Assessment of brain reward system activation after visual/taste cues using functional MRI
Measured: Controls: 0 months; Morbidly obese: preoperatively, 6 months, 12 months, 24 months postoperatively
Changes in brain μ-opioid receptor availability using PET imaging
Assessment of brain μ-opioid receptor availability using [11C]-carfentanil tracer and positron emission tomography
Measured: Controls: 0 months; Morbidly obese: preoperatively, 6 months, 12 months postoperatively
Changes in cognitive function studied with testing
Neuropsychological testing focusing on memory, decision-making and inhibition
Measured: Controls: 0 months; Morbidly obese: preoperatively, 6 months, 12 months, 24 months postoperatively
Changes in whole-body insulin sensitivity usign FDG-PET imaging
Assessment of whole-body insulin sensitivity using hyperinsulinemic, euglycemic clamp
Measured: Controls: 0 months; Morbidly obese: preoperatively, 6 months postoperatively
Changes in tissue-specific insulin sensitivity using FDG-PET imaging
Assessment of insulin-stimulated glucose uptake in the brain, liver, skeletal muscle and adipose tissue by performing positron emission tomography with [18F]-fluorodeoxyglucose tracer during hyperinsulinemic, euglycemic clamp
Measured: Controls: 0 months; Morbidly obese: preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start11 Feb 2019
- Primary completion10 Oct 2021
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 60 subjects undergoing bariatric surgery (either Roux-en-Y gastric bypass or Sleeve gastrectomy) and 30 healthy controls
- Masking
- None (open label)
- Enrolment
- 30 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 University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080205
- Sponsor's protocol ID
- BariBrain-PET
- Other IDs
- T153/2018
- Acronym
- BariBrainPET
- Status last verified
- Oct 2021
- First submitted
- 6 Jun 2018
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Under preparation.
Study at a glance
From the registry record, last updated by the sponsor on 15 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
- NCT05080205
- Acronym / sponsor ID
- BariBrainPET / BariBrain-PET
- Conditions
- Obesity, Morbid, Insulin Resistance
- Keywords
- obesity, insulin resistance, central nervous system inflammation, bariatric surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 10 Oct 2021 (actual)
- Study completion
- Dec 2022 (estimated)
- First posted
- 15 Oct 2021 (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: Morbid obesity is associated with decreased brain µ-opioid receptor availability, possibly resulting in higher food intake needed to gain pleasure from eating. This decrease seems to normalize already 6 months after bariatric surgery, but the longer-term effects have not been studied. Obesity and insulin resistance result in significantly increased brain insulin-stimulated glucose uptake, whereas in every other tissue glucose uptake is lower. 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. Obesity has also been shown to associate with increased risk of Alzheimer's disease and cognitive decline in several studies.
Aims: The first objective of this study is to both study the effects of bariatric surgery as well as compare the effects of gastric bypass and sleeve gastrectomy on food-associated pleasure, extending the follow-up period to 2 years postoperatively. The second aim is to investigate the effect of morbid obesity and weight loss on brain inflammation and gliosis and its association with increased brain insulin-stimulated glucose uptake. Furthermore, association of obesity, insulin resistance, central inflammation and neurocognitive dysfunction are evaluated.
Detailed description
Methods: A total of 60 morbidly obese subjects, 30 assigned for Roux-en-Y gastric bypass and 30 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. We will perform 1) structural MRI and MRS, 2) functional MRI during tasting and visual food cues, 3) PET imaging of µ-opioid receptor availability using [11C]-carfentanil, 4) PET imaging of cerebral inflammation and astrocyte activation using [11C]-PK11195, 5) measurement of whole-body and tissue insulin sensitivity by combining hyperinsulinemic, euglycemic clamp with [18F]-FDG-PET, 6) neuropsychological testing. The control group will only be studied once, whereas study procedures will be repeated for the morbidly obese before very-low calorie diet and 6, 12 and 24 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 60 subjects undergoing bariatric surgery (either Roux-en-Y gastric bypass or Sleeve gastrectomy) and 30 healthy controls
| Arm | Type | Receives |
|---|---|---|
| Morbidly obese subjects | Experimental | Procedure: Bariatric surgeryBariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy) |
| Control subjects | No intervention | –Non-obese controls are only studied at baseline |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Morbidly obese group
- BMI 35.0-45.0 kg/m2, or BMI 32.0-45.0 kg/m2 and diagnosed diabetes
- Age 18-60 years
- Eligible to bariatric surgery evaluated according to normal treatment paradigm
- Non-obese controls
Key exclusion criteria (17 listed)
- Morbidly obese group
- Metal objects in the body (including pacemakers, metallic artificial valve prostheses, inner ear implants, surgical clipses, braces, foreign fragments)
- Previous participation in PET studies
- Pregnancy
- Poor compliance, alcohol 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 |
|---|---|---|
| Bariatric surgeryAlso: Roux-en-Y gastric bypass, Sleeve gastrectomyRoux-en-Y gastric bypass or sleeve gastrectomy, chosen based on routine evaluation process | Procedure or surgery | Morbidly obese subjects |
Primary outcome
Change in central inflammation
Time frame: Controls: 0 months; Morbidly obese: preoperatively, 6 months postoperatively
Assessment of brain glial cell activation using [11C]-PK11195 tracer and positron emission tomography
5 secondary outcomes
Changes in central reward system using fMRI imaging
Time frame: Controls: 0 months; Morbidly obese: preoperatively, 6 months, 12 months, 24 months postoperatively
Changes in brain μ-opioid receptor availability using PET imaging
Time frame: Controls: 0 months; Morbidly obese: preoperatively, 6 months, 12 months postoperatively
Changes in cognitive function studied with testing
Time frame: Controls: 0 months; Morbidly obese: preoperatively, 6 months, 12 months, 24 months postoperatively
Changes in whole-body insulin sensitivity usign FDG-PET imaging
Time frame: Controls: 0 months; Morbidly obese: preoperatively, 6 months postoperatively
Changes in tissue-specific insulin sensitivity using FDG-PET imaging
Time frame: Controls: 0 months; Morbidly obese: preoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Individual participant dataSharing planned: Yes. Under preparation.
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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 University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric surgery in people with Obesity, Morbid and Insulin Resistance, 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 9 inclusion and 17 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 15 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 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?
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?
Change in central inflammation (time frame: Controls: 0 months; Morbidly obese: preoperatively, 6 months postoperatively). 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 15 Oct 2021.