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The Role of Secretin on the Energy Homeostasis

Plain-language guide to NCT04613700: not phased randomized trial of Secretin, 25 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04613700
Phase
not phased
Status
completed
Start
2020-03-01
Completion (planned or actual)
2020-09-29
Participants
25 (actual)
Design
randomized, triple-blind, basic_science
Conditions studied
Obesity; Metabolic Disease; Diabetes; Adiposity
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Secretin.

The mechanisms behind these regulatory effect of secretin on energy homeostasis are unclear,.

It had two arms (groups): Secretin (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

Secretin was - as the first hormone - identified in 19021, but was not isolated until the 1960s.

Secretin is produced in and secreted form small intestinal S cells.

In the 1970s, the primary endocrine effects of secretin were unequivocally confirmed, namely potentiation of bicarbonate and pepsin secretion from the pancreas as well as stimulation of bile production in the liver.

In the 1990s, the biosynthesis of secretin was delineated and its receptor was discovered.

Who Took Part

The registry lists 25 actual participants took part.

It was open to men only aged from 18 years up to 75 years.

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

Examples of who could join: Age between 18 and 75 years. Body mass index between 18.5 and 27.5 kg/m2. Body weight above 50 kg.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: anaemia (blood haemoglobin below normal range); known liver disease and/or alanine aminotransferase and/or aspartate transaminase \> 2 times upper normal values; nephropathy (serum creatinine above normal range and/or albuminuria).

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

The participants were allocated by chance, so the Secretin group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Secretin and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Secretin.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2020-03-01 with completion listed for 2020-09-29.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Food intake on ad libitum meal (time frame: 300 minutes). Duration of ad libitum meal (time frame: 300 minutes).

It also tracked 8 secondary outcomes, for example Water intake during ad libitum meal, resting energy expenditure, Supraclavicular Brown adipose activity, Appetite and satiety sensations (assessed by VASs),, Heart rate and systolic blood pressure.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Secretin in 25 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.