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ObesityPhase 2/3GUTBATNCT03290846

Secretin Activates Human Brown Fat and Induces Satiation.

A Phase 2/3 study testing Secretin Human, Saline Solution and Cold exposure in people with Obesity, run by Turku University Hospital at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

15 healthy males will be studied with PET/CT, using FDG to investigate glucose metabolism, and radiowater to investigate perfusion. One scan will be performed in controlled cold exposure, to see whether subjects have cold activated brown adipose tissue. Read more about this study

Who is it for?
Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Secretin Human, Saline Solution and Cold exposure
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteFinland
Study dates
2 Aug 2016to 30 Nov 2019
Phase
Phase 2/3
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 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • healthy normal weight

Who cannot join

  • cardiovascular disease, diabetes
  • smoking

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Turku PET Centre

    Turku, 20521

Other trials in Finland

About this study

Official title: Secretin Increases Glucose Uptake in Human Brown Adipose Tissue and Induces Satiation.

15 healthy males will be studied with PET/CT, using FDG to investigate glucose metabolism, and radiowater to investigate perfusion. One scan will be performed in controlled cold exposure, to see whether subjects have cold activated brown adipose tissue. Two scans will be performed in room temperature conditions, where all subjects are blinded and randomised to receive placebo and secretin hydrochloride. PET/CT scans will be analysed blinded.

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.

Read the detailed description

The PET/CT study will consist of 15 healthy, normal weight males, between ages 18-65. A 2-hour oral glucose tolerance test is performed on screening day. Calorimetry data is collected at baseline (resting and fasting) condition.

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
Obesity
Being tested
Secretin Human, Saline Solution, Cold exposure
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Secretin HumanDrug

    Randomized, single-blinded secretin hydrochloride infusion.

  • Saline SolutionDrug

    Randomized, single-blinded saline infusion.

  • Cold exposureOther

    All subjects will undergo a cold exposure PET scan.

Study groups in NCT03290846
Study groupRoleWhat they receive
Secretin studyExperimentalPET 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.
Receives: Drug: Secretin Human; Drug: Saline Solution; Other: Cold exposure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Secretin activates brown fat

    Secretin increases brown adipose tissue glucose uptake compared to placebo. This is studied with PET/CT, using a glucose tracer.

    Measured: Effect within one hour

  2. Secretin activates brown fat

    Secretin increases brown adipose tissue flow compared to placebo. This is studied with PET/CT, using a radiowater tracer.

    Measured: Effect within six minutes

  3. Secretin induces satiation

    Secretin attenuates brain activity, when subjects are viewing palatable vs. non-palatable food images.

    Measured: Effect within one hour

Secondary outcomes (3)

  1. Secretin increases whole body energy expenditure

    Secretin increases whole body energy expenditure compared to placebo. Data is collected durin PET/CT scans by indirect calorimetry.

    Measured: Effect within two hours

  2. Secretin induces satiety

    Composite satiety score is measured by visual analogue scale questionnaire

    Measured: Effect within three hours

  3. Secretin reduces food consumption.

    Data on food consumption is collected directly after scan, as well as with food diaries. Calory intake is measured and comparisons are made between secretin and placebo.

    Measured: Within three days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2017
  2. Study start2 Aug 2016
  3. Primary completion30 Oct 2019
  4. Study completion30 Nov 2019

Resources

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 2/3
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
Single blinded randomised study, secretin infusion is given on one day, saline infusion on an other day.
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03290846
Sponsor's protocol ID
T153/2016
Acronym
GUTBAT
Status last verified
Dec 2019
First submitted
19 Sep 2017
Last updated
23 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No data, where participants could be identifiable, will be shared.

Publications

  • 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.

    PubMed 36764966

  • 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.

    PubMed 34806426

  • 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.

    PubMed 34158656

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Secretin Human, Saline Solution and Cold exposure in people with 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 2 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 23 Dec 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Secretin activates brown fat (time frame: Effect within one hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03290846, which also lists 3 linked publications.

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 23 Dec 2019.

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