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The Role of Secretin on the Energy Homeostasis (THE-ROSE)

Primary Purpose

Obesity, Metabolic Disease, Diabetes

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Secretin
Placebo
Sponsored by
Steno Diabetes Center Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Herlev- Gentofte Hospital, Center for Clinical Metabolic Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Secretin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Food intake on ad libitum meal
Kilojoule
Duration of ad libitum meal
Duration in minutes

Secondary Outcome Measures

Water intake during ad libitum meal
mL
resting energy expenditure
Indirect calorimetry of respiration
Supraclavicular Brown adipose activity
Evaluated by neck skin temperature assessed using a non-invasive thermal imaging camera)
Appetite and satiety sensations (assessed by VASs),
Visual analogue scales with a scale of 1-10 (Direction of scale varies)
Heart rate
heart rate .
systolic blood pressure
Systolic blood pressure
Diastolic blood pressure
Diastolic blood pressures
Gallbladder motility
Gallbladder motility measured by Ultrasound

Full Information

First Posted
October 19, 2020
Last Updated
November 3, 2020
Sponsor
Steno Diabetes Center Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT04613700
Brief Title
The Role of Secretin on the Energy Homeostasis
Acronym
THE-ROSE
Official Title
The Role of Secretin on the Energy Homeostasis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
September 29, 2020 (Actual)
Study Completion Date
September 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Steno Diabetes Center Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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,
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Metabolic Disease, Diabetes, Adiposity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
randomised, double-blinded, placebo-controlled, cross-over study
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filip K Knop, Professor, MD
Organizational Affiliation
Gentofte Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev- Gentofte Hospital, Center for Clinical Metabolic Research
City
Hellerup
State/Province
Copenhagen
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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The Role of Secretin on the Energy Homeostasis

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