Obesity Clinical Trial
— GUTBATOfficial title:
Secretin Increases Glucose Uptake in Human Brown Adipose Tissue and Induces Satiation.
Verified date | December 2019 |
Source | Turku University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | November 30, 2019 |
Est. primary completion date | October 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - healthy normal weight Exclusion Criteria: - cardiovascular disease, diabetes - smoking |
Country | Name | City | State |
---|---|---|---|
Finland | Turku PET Centre | Turku |
Lead Sponsor | Collaborator |
---|---|
Turku University Hospital | Technische Universität München |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Secretin induces changes in biomarkers and metabolites. | Serum samples are collected during PET/CT scan and analyzed. | Within two hours | |
Other | Brown adipose tissue biopsies. | Brown adipose tissue biopsy samples are collected from subjects and analyzed. | Within 2 months | |
Primary | Secretin activates brown fat | Secretin increases brown adipose tissue glucose uptake compared to placebo. This is studied with PET/CT, using a glucose tracer. | Effect within one hour | |
Primary | Secretin activates brown fat | Secretin increases brown adipose tissue flow compared to placebo. This is studied with PET/CT, using a radiowater tracer. | Effect within six minutes | |
Primary | Secretin induces satiation | Secretin attenuates brain activity, when subjects are viewing palatable vs. non-palatable food images. | Effect within one hour | |
Secondary | 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. | Effect within two hours | |
Secondary | Secretin induces satiety | Composite satiety score is measured by visual analogue scale questionnaire | Effect within three hours | |
Secondary | 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. | Within three days |
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