- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05080205
Effects of Morbid Obesity and Bariatric Surgery on Brain Inflammation, Insulin Resistance and Central Reward System (BariBrainPET)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Turku, Finland, 20520
- Turku PET Centre
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion criteria:
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
- Age 18-60 years
- Fasting plasma glucose ≤6.1 mmol/L
- Normal values in 2-hour oral glucose tolerance test
Exclusion criteria:
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
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Morbidly obese subjects
Bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy)
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Roux-en-Y gastric bypass or sleeve gastrectomy, chosen based on routine evaluation process
Andre navne:
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Ingen indgriben: Control subjects
Non-obese controls are only studied at baseline
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in central inflammation
Tidsramme: Controls: 0 months; Morbidly obese: preoperatively, 6 months postoperatively
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Assessment of brain glial cell activation using [11C]-PK11195 tracer and positron emission tomography
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Controls: 0 months; Morbidly obese: preoperatively, 6 months postoperatively
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Changes in central reward system using fMRI imaging
Tidsramme: Controls: 0 months; Morbidly obese: preoperatively, 6 months, 12 months, 24 months postoperatively
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Assessment of brain reward system activation after visual/taste cues using functional MRI
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Controls: 0 months; Morbidly obese: preoperatively, 6 months, 12 months, 24 months postoperatively
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Changes in brain μ-opioid receptor availability using PET imaging
Tidsramme: Controls: 0 months; Morbidly obese: preoperatively, 6 months, 12 months postoperatively
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Assessment of brain μ-opioid receptor availability using [11C]-carfentanil tracer and positron emission tomography
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Controls: 0 months; Morbidly obese: preoperatively, 6 months, 12 months postoperatively
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Changes in cognitive function studied with testing
Tidsramme: Controls: 0 months; Morbidly obese: preoperatively, 6 months, 12 months, 24 months postoperatively
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Neuropsychological testing focusing on memory, decision-making and inhibition
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Controls: 0 months; Morbidly obese: preoperatively, 6 months, 12 months, 24 months postoperatively
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Changes in whole-body insulin sensitivity usign FDG-PET imaging
Tidsramme: Controls: 0 months; Morbidly obese: preoperatively, 6 months postoperatively
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Assessment of whole-body insulin sensitivity using hyperinsulinemic, euglycemic clamp
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Controls: 0 months; Morbidly obese: preoperatively, 6 months postoperatively
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Changes in tissue-specific insulin sensitivity using FDG-PET imaging
Tidsramme: Controls: 0 months; Morbidly obese: preoperatively
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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
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Controls: 0 months; Morbidly obese: preoperatively
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Pirjo Nuutila, MD, PhD, Turku University Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Infektioner
- Overernæring
- Ernæringsforstyrrelser
- Overvægtig
- Kropsvægt
- Infektioner i centralnervesystemet
- Hyperinsulinisme
- Fedme
- Encephalitis
- Betændelse
- Insulin resistens
- Fedme, sygelig
- Infektiøs encephalitis
Andre undersøgelses-id-numre
- BariBrain-PET
- T153/2018 (Anden identifikator: The Hospital District of Southwest Finland)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-deling Understøttende informationstype
- Studieprotokol
- Statistisk analyseplan (SAP)
- Formular til informeret samtykke (ICF)
- Klinisk undersøgelsesrapport (CSR)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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