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Secretin Activates Human Brown Fat and Induces Satiation.

Plain-language guide to NCT03290846: phase 2, phase 3 interventional trial of Secretin, 23 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03290846
Phase
phase 2, phase 3
Status
completed
Start
2016-08-02
Completion (planned or actual)
2019-10-30
Participants
23 (actual)
Design
na, open label (everyone knows who gets what), basic_science
Conditions studied
Obesity
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 2, phase 3 trial tested Secretin.

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.

It had 1 arm (groups): Secretin study (experimental).

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.

The registry classes the interventions as drug and other.

More on the Plan

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.

Who Took Part

23 actual participants took part.

It was open to men only aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy normal weight.

The full record lists 1 inclusion and 2 exclusion criteria; among the exclusions: cardiovascular disease, diabetes.

How the Study Was Run

It was run as a single-group and open-label study.

Nothing was hidden in this open-label Secretin study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2016-08-02 with completion listed for 2019-10-30.

It ran at 1 site in Finland.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Secretin activates brown fat (time frame: Effect within one hour). Secretin activates brown fat (time frame: Effect within six minutes). Secretin induces satiation (time frame: Effect within one hour).

It also tracked 3 secondary outcomes, for example Secretin induces satiety.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3 trial of Secretin in 23 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Secretin compound page, all human trials.

Our Notes on the Compound

Secretin: A 27-amino-acid gut hormone that triggers pancreatic secretion; used as a diagnostic agent in pancreatic function testing.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.