THE-ROSE: The Role of Secretin on the Energy Homeostasis

• Sponsor: Steno Diabetes Center Copenhagen (Other)
• Overall Status: Completed
• CT.gov ID: NCT04613700
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 2
• Actual Duration (Months): 7
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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,

Condition or Disease	Intervention/Treatment	Phase
Obesity; Metabolic Disease; Diabetes; Adiposity	Drug: Secretin; Other: Placebo	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: randomised, double-blinded, placebo-controlled, cross-over studyrandomised, double-blinded, placebo-controlled, cross-over study
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Basic Science
• Official Title: The Role of Secretin on the Energy Homeostasis
• Actual Study Start Date: Mar 1, 2020
• Actual Primary Completion Date: Sep 29, 2020
• Actual Study Completion Date: Sep 29, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Secretin	Drug: Secretin; Native hormone
Placebo Comparator: Placebo	Other: Placebo; Saline

Outcome Measures

Primary Outcome Measures

1. Food intake on ad libitum meal [300 minutes]

   Kilojoule

2. Duration of ad libitum meal [300 minutes]

   Duration in minutes

Secondary Outcome Measures

1. Water intake during ad libitum meal [300 minutes]

   mL

2. resting energy expenditure [Baseline, 90 minutes and 270 minutes]

   Indirect calorimetry of respiration

3. Supraclavicular Brown adipose activity [-15 to 15 , 90 and 270 minutes]

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

4. Appetite and satiety sensations (assessed by VASs), [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)

5. Heart rate [every 15 minutes from from -15 to 300 minutes]

   heart rate .

6. systolic blood pressure [every 15 minutes from from -15 to 300 minutes]

   Systolic blood pressure

7. Diastolic blood pressure [every 15 minutes from from -15 to 300 minutes]

   Diastolic blood pressures

8. Gallbladder motility [Timepoint -30, 10,20,45,60,75,90,120,210,300 minutes]

   Gallbladder motility measured by Ultrasound

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Herlev- Gentofte Hospital, Center for Clinical Metabolic Research	Hellerup	Copenhagen	Denmark	2900

Sponsors and Collaborators

• Steno Diabetes Center Copenhagen

Investigators

• Principal Investigator: Filip K Knop, Professor, MD, Gentofte Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Steno Diabetes Center Copenhagen
• ClinicalTrials.gov Identifier: NCT04613700
• Other Study ID Numbers: The-ROSE
• First Posted: Nov 3, 2020
• Last Update Posted: Nov 5, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Metabolic Diseases; Secretin

Study Results

No Results Posted as of Nov 5, 2020