Secretin Activates Human Brown Fat and Induces Satiation. (GUTBAT)

December 20, 2019 updated by: Pirjo Nuutila, Turku University Hospital

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Turku, Finland, 20521
        • Turku PET Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy normal weight

Exclusion Criteria:

  • cardiovascular disease, diabetes
  • smoking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Randomized, single-blinded secretin hydrochloride infusion.
Randomized, single-blinded saline infusion.
All subjects will undergo a cold exposure PET scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secretin activates brown fat
Time Frame: Effect within one hour
Secretin increases brown adipose tissue glucose uptake compared to placebo. This is studied with PET/CT, using a glucose tracer.
Effect within one hour
Secretin activates brown fat
Time Frame: Effect within six minutes
Secretin increases brown adipose tissue flow compared to placebo. This is studied with PET/CT, using a radiowater tracer.
Effect within six minutes
Secretin induces satiation
Time Frame: Effect within one hour
Secretin attenuates brain activity, when subjects are viewing palatable vs. non-palatable food images.
Effect within one hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secretin increases whole body energy expenditure
Time Frame: Effect within two hours
Secretin increases whole body energy expenditure compared to placebo. Data is collected durin PET/CT scans by indirect calorimetry.
Effect within two hours
Secretin induces satiety
Time Frame: Effect within three hours
Composite satiety score is measured by visual analogue scale questionnaire
Effect within three hours
Secretin reduces food consumption.
Time Frame: Within three days
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.
Within three days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secretin induces changes in biomarkers and metabolites.
Time Frame: Within two hours
Serum samples are collected during PET/CT scan and analyzed.
Within two hours
Brown adipose tissue biopsies.
Time Frame: Within 2 months
Brown adipose tissue biopsy samples are collected from subjects and analyzed.
Within 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pirjo R Nuutila, MD,PhD, Turku UH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2016

Primary Completion (Actual)

October 30, 2019

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

September 19, 2017

First Submitted That Met QC Criteria

September 20, 2017

First Posted (Actual)

September 25, 2017

Study Record Updates

Last Update Posted (Actual)

December 23, 2019

Last Update Submitted That Met QC Criteria

December 20, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No data, where participants could be identifiable, will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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