The Role of Secretin on the Energy Homeostasis

Obesity Clinical Trial

— THE-ROSE  

Official title:

The Role of Secretin on the Energy Homeostasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04613700
• Other study ID #: The-ROSE
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: September 29, 2020

Study information

• Verified date: November 2020
• Source: Steno Diabetes Center Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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,

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 29, 2020
• Est. primary completion date: September 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adiposity
• Diabetes
• Metabolic Disease
• Metabolic Diseases
• Obesity

Intervention

Drug:
• Secretin
Native hormone

Other:
• Placebo
Saline

Locations

Country	Name	City	State
Denmark	Herlev- Gentofte Hospital, Center for Clinical Metabolic Research	Hellerup	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Steno Diabetes Center Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Food intake on ad libitum meal	Kilojoule	300 minutes
Primary	Duration of ad libitum meal	Duration in minutes	300 minutes
Secondary	Water intake during ad libitum meal	mL	300 minutes
Secondary	resting energy expenditure	Indirect calorimetry of respiration	Baseline, 90 minutes and 270 minutes
Secondary	Supraclavicular Brown adipose activity	Evaluated by neck skin temperature assessed using a non-invasive thermal imaging camera)	-15 to 15 , 90 and 270 minutes
Secondary	Appetite and satiety sensations (assessed by VASs),	Visual analogue scales with a scale of 1-10 (Direction of scale varies)	Every 15 minutes after infusion, until time-point 90, hereafter every 30 minutes
Secondary	Heart rate	heart rate .	every 15 minutes from from -15 to 300 minutes
Secondary	systolic blood pressure	Systolic blood pressure	every 15 minutes from from -15 to 300 minutes
Secondary	Diastolic blood pressure	Diastolic blood pressures	every 15 minutes from from -15 to 300 minutes
Secondary	Gallbladder motility	Gallbladder motility measured by Ultrasound	Timepoint -30, 10,20,45,60,75,90,120,210,300 minutes