Clinical trial NCT04613700: The Role of Secretin on the Energy Homeostasis
Official title: The Role of Secretin on the Energy Homeostasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Metabolic Disease
Diabetes
Adiposity
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomised, double-blinded, placebo-controlled, cross-over study
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Food intake on ad libitum meal
timeFrame: 300 minutes
measure: Duration of ad libitum meal
timeFrame: 300 minutes
Secondary outcomes:
measure: Water intake during ad libitum meal
timeFrame: 300 minutes
measure: resting energy expenditure
timeFrame: Baseline, 90 minutes and 270 minutes
measure: Supraclavicular Brown adipose activity
timeFrame: -15 to 15 , 90 and 270 minutes
measure: Appetite and satiety sensations (assessed by VASs),
timeFrame: Every 15 minutes after infusion, until time-point 90, hereafter every 30 minutes
measure: Heart rate
timeFrame: every 15 minutes from from -15 to 300 minutes
measure: systolic blood pressure
timeFrame: every 15 minutes from from -15 to 300 minutes
measure: Diastolic blood pressure
timeFrame: every 15 minutes from from -15 to 300 minutes
measure: Gallbladder motility
timeFrame: Timepoint -30, 10,20,45,60,75,90,120,210,300 minutes
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Herlev- Gentofte Hospital, Center for Clinical Metabolic Research
state: Copenhagen
Study officials:
affiliation: Gentofte Hospital
name: Filip K Knop, Professor, MD
role: PRINCIPAL_INVESTIGATOR
References: