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The Role of Secretin on the Energy Homeostasis

NCT ID: NCT04613700

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2020-09-29

Brief Summary

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As of last year, new insight into the function of secretin was brought about as rodent studies showed secretin to possess potential body weight-regulating effects. In these studies, secretin was shown to increase non-shivering thermogenesis in brown adipose tissue (BAT), decrease meal size and promote meal discontinuation. The mechanisms behind these regulatory effect of secretin on energy homeostasis are unclear,

Detailed Description

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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. In the 2000s the pancreatic regulation of intestinal pH was shown to be secretin-mediated. As of last year, new insight into the function of secretin was brought about as rodent studies showed secretin to possess potential body weight-regulating effects. In these studies, secretin was shown to increase non-shivering thermogenesis in brown adipose tissue (BAT), decrease meal size and promote meal discontinuation.

The primary aim of this study is to evaluate the effect of a 5-hour intravenous infusion with the naturally occurring hormone secretin on ad libitum food intake (primary endpoint) compared to a double-blinded placebo (isotonic saline) infusion in 25 healthy young males.

Conditions

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Obesity Metabolic Disease Diabetes Adiposity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

randomised, double-blinded, placebo-controlled, cross-over study
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Secretin

Group Type ACTIVE_COMPARATOR

Secretin

Intervention Type DRUG

Native hormone

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Saline

Interventions

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Secretin

Native hormone

Intervention Type DRUG

Placebo

Saline

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 75 years
* Body mass index between 18.5 and 27.5 kg/m2
* Informed consent
* Body weight above 50 kg

Exclusion Criteria

* 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)
* Clinically significant kidney function impairment or other laboratory findings leading to the diagnosis of clinically relevant disorders (thyroid dysfunction, anaemia etc)
* Any physical or psychological condition that the investigators feel would interfere with trial participation
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Steno Diabetes Center Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Filip K Knop, Professor, MD

Role: PRINCIPAL_INVESTIGATOR

Gentofte Hospital

Locations

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Herlev- Gentofte Hospital, Center for Clinical Metabolic Research

Hellerup, Copenhagen, Denmark

Site Status

Countries

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Denmark

References

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Heimburger SMN, Bentzen MJ, Kizilkaya HS, Hartmann B, Holst JJ, Rosenkilde MM, Dela F, Hansen SH, Rehfeld JF, Christensen MB, Knop FK. Secretin infusion decreases food intake in healthy men-a randomized, placebo-controlled, double-blind, crossover study. Eur J Endocrinol. 2024 Nov 27;191(6):545-557. doi: 10.1093/ejendo/lvae147.

Reference Type DERIVED
PMID: 39556772 (View on PubMed)

Other Identifiers

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The-ROSE

Identifier Type: -

Identifier Source: org_study_id