Secretin Activates Human Brown Fat and Induces Satiation.
NCT ID: NCT03290846
Last Updated: 2019-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
23 participants
INTERVENTIONAL
2016-08-02
2019-11-30
Brief Summary
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20 healthy males will also be studied with fMRI, in order to investigate brain activity responses to appetizing versus bland foods. This study will be conduced on the same patients as the PET/CT study, but additional subjects with same inclusion and exclusion criteria will be recruited. Two fMRI scans will be performed in room temperature conditions, where all subjects are blinded and randomised to receive placebo and secretin hydrochloride. fMRI scans will be analysed blinded.
Detailed Description
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Three PET/CT scans on three different days will be performed to all 15 study subjects. Radiowater (15O)-H2O is used to study perfusion and FDG ((F18)-FDG) to study glucose metabolism. After radiowater, PET data is collected from the neck area for 6 minutes. After FDG, PET data is collected for 40 minutes on the neck area, 15 minutes on the chest, 15 minutes on the abdomen and 15 minutes on the brain. Calorimetry is collected during the entire scan. Blood samples are collected during scans for metabolites and for a plasma activity curve.
One scan is performed during controlled, cold exposure. This is done to investigate, whether patients have cold activated brown adipose tissue. After this, subjects will undergo two room temperature condition scans on different days, where participants are single-blinded and randomised to receive placebo (saline) or secretin (secretin hydrochloride) infusions. All scans are done in fasting conditions. After subjects have fed at the PET centre, calorimetry data is collected on all days.
A full body MRI will be performed on a separate day with the Dixon-method.
After scanning visits, brown adipose tissue biopsies will be taken from volunteers by a plastic surgeon. These samples are analysed in Munich.
Dynamic scan data is analysed with the Carimas program, using Patlak plot. Analysis is performed blinded. Further statistics analysis is done with SPSS.
The fMRI study will consist of 20 healthy, normal weight males, between ages 18-65. Subjects who underwent PET/CT scanning will be recruited for this study, as well as an additional group of subjects with the same inclusion and exclusion criteria. A 2-hour oral glucose tolerance test is performed on screening day for additional subjcts.
Two fMRI scans are conducted in room temperature after overnight fast on separate days. Subjects are randomized and blinded to receive placebo and secretin hydrochloride on separate days. Data on brain activity while viewing appetizing versus bland food images is collected during scan. After scanning subjects are given a meal and then followed up for two hours. Data on subjective satiety will be collected with a visual analogue scale questionnaire on nine different timepoints during the day: in preprandial, prandial and postprandial conditions.
Functional MRI data is analyzed with Matlab. Analysis is performed blinded. Satiety score is analzed with SPSS.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Secretin study
PET and MRI scannings will be performed twice. Subjects will be given secretin hydrochloride and placebo on separate days. In addition, subjects will undergo cold exposure PET scanning once.
Secretin Human
Randomized, single-blinded secretin hydrochloride infusion.
Saline Solution
Randomized, single-blinded saline infusion.
Cold exposure
All subjects will undergo a cold exposure PET scan.
Interventions
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Secretin Human
Randomized, single-blinded secretin hydrochloride infusion.
Saline Solution
Randomized, single-blinded saline infusion.
Cold exposure
All subjects will undergo a cold exposure PET scan.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* smoking
18 Years
65 Years
MALE
Yes
Sponsors
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Technical University of Munich
OTHER
Turku University Hospital
OTHER_GOV
Responsible Party
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Pirjo Nuutila
Professor, MD PhD
Principal Investigators
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Pirjo R Nuutila, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Turku UH
Locations
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Turku PET Centre
Turku, , Finland
Countries
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References
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Sun L, Laurila S, Lahesmaa M, Rebelos E, Virtanen KA, Schnabl K, Klingenspor M, Nummenmaa L, Nuutila P. Secretin modulates appetite via brown adipose tissue-brain axis. Eur J Nucl Med Mol Imaging. 2023 May;50(6):1597-1606. doi: 10.1007/s00259-023-06124-4. Epub 2023 Feb 11.
Laurila S, Rebelos E, Lahesmaa M, Sun L, Schnabl K, Peltomaa TM, Klen R, U-Din M, Honka MJ, Eskola O, Kirjavainen AK, Nummenmaa L, Klingenspor M, Virtanen KA, Nuutila P. Novel effects of the gastrointestinal hormone secretin on cardiac metabolism and renal function. Am J Physiol Endocrinol Metab. 2022 Jan 1;322(1):E54-E62. doi: 10.1152/ajpendo.00260.2021. Epub 2021 Nov 22.
Laurila S, Sun L, Lahesmaa M, Schnabl K, Laitinen K, Klen R, Li Y, Balaz M, Wolfrum C, Steiger K, Niemi T, Taittonen M, U-Din M, Valikangas T, Elo LL, Eskola O, Kirjavainen AK, Nummenmaa L, Virtanen KA, Klingenspor M, Nuutila P. Secretin activates brown fat and induces satiation. Nat Metab. 2021 Jun;3(6):798-809. doi: 10.1038/s42255-021-00409-4. Epub 2021 Jun 21.
Other Identifiers
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T153/2016
Identifier Type: -
Identifier Source: org_study_id