Current partner codePEPTIDESDE
NCT04613700·Not applicable·INTERVENTIONAL

The Role of Secretin on the Energy Homeostasis

Status

Completed

Phase

Not applicable

Enrollment

25

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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,

Full detailed description

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.

Interventions

Treatment arms and agents.

DRUG

Secretin

Native hormone

OTHER

Placebo

Saline

Timeline

From registration to results.

  1. First posted

    Nov 3, 2020

  2. Study start

    Mar 1, 2020

  3. Primary completion

    Sep 29, 2020

  4. Study completion

    Sep 29, 2020

  5. Results posted

    Not reported

  6. Registry updated

    Nov 5, 2020

Outcomes

What the study measures.

Primary outcomes

Food intake on ad libitum meal

Time frame · 300 minutes

Kilojoule

Duration of ad libitum meal

Time frame · 300 minutes

Duration in minutes

Secondary outcomes

Water intake during ad libitum meal

Time frame · 300 minutes

mL

resting energy expenditure

Time frame · Baseline, 90 minutes and 270 minutes

Indirect calorimetry of respiration

Supraclavicular Brown adipose activity

Time frame · -15 to 15 , 90 and 270 minutes

Evaluated by neck skin temperature assessed using a non-invasive thermal imaging camera)

Appetite and satiety sensations (assessed by VASs),

Time frame · Every 15 minutes after infusion, until time-point 90, hereafter every 30 minutes

Visual analogue scales with a scale of 1-10 (Direction of scale varies)

Heart rate

Time frame · every 15 minutes from from -15 to 300 minutes

heart rate .

systolic blood pressure

Time frame · every 15 minutes from from -15 to 300 minutes

Systolic blood pressure

Diastolic blood pressure

Time frame · every 15 minutes from from -15 to 300 minutes

Diastolic blood pressures

Gallbladder motility

Time frame · Timepoint -30, 10,20,45,60,75,90,120,210,300 minutes

Gallbladder motility measured by Ultrasound

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
MALE
Healthy volunteers
Yes

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

Study locations

1 registered sites.

Denmark. Showing up to 24 locations stored in the fast local snapshot.

Herlev- Gentofte Hospital, Center for Clinical Metabolic Research

Hellerup, Copenhagen, Denmark

Related trials

More studies on Secretin.

Related PeptideStat pages

Put the record in context.

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