The Role of Secretin on the Energy Homeostasis | NCT04613700

Studies
The Role of Secretin on the Energy Homeostasis

NCT04613700

Sponsor

Steno Diabetes Center Copenhagen

Status

Completed

Last Update Posted

Nov 5, 2020Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Obesity
Metabolic Disease
Diabetes
Adiposity

Interventions

Secretin
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2020Actual

Primary Completion Date

Sep 29, 2020Actual

Completion Date

Sep 29, 2020Actual

First Submitted Date

Oct 19, 2020

First Submission Date that Met QC Criteria

Nov 2, 2020

First Posted Date

Nov 3, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2020

Last Update Posted Date

Nov 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Secretin	Active Comparator		Drug: Secretin
Placebo	Placebo Comparator		Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Secretin	Drug	Native hormone	Secretin
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Food intake on ad libitum meal	Kilojoule	300 minutes
Duration of ad libitum meal	Duration in minutes	300 minutes

Secondary Outcomes

Measure	Description	Time Frame
Water intake during ad libitum meal	mL	300 minutes
resting energy expenditure	Indirect calorimetry of respiration	Baseline, 90 minutes and 270 minutes

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Filip K Knop, Professor, MD	Gentofte Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herlev- Gentofte Hospital, Center for Clinical Metabolic Research		Hellerup	Copenhagen	2900	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39556772	Derived	Heimburger SMN, Bentzen MJ, Kizilkaya HS, Hartmann B, Holst JJ, Rosenkilde MM, Dela F, Hansen SH, Rehfeld JF, Christensen MB, Knop FK. Secretin infusion decreases food intake in healthy men-a randomized, placebo-controlled, double-blind, crossover study. Eur J Endocrinol. 2024 Nov 27;191(6):545-557. doi: 10.1093/ejendo/lvae147.

ID	Term
D009765	Obesity
D008659	Metabolic Diseases
D003920	Diabetes Mellitus

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

ID	Term
D005768	Gastrointestinal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D036361	Peptide Hormones