NCT04613700

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,

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2020

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

7 months

First QC Date

October 19, 2020

Last Update Submit

November 3, 2020

Conditions

ObesityMetabolic DiseaseDiabetesAdiposity

Outcome Measures

Primary Outcomes (2)

  • Food intake on ad libitum meal

    Kilojoule

    300 minutes

  • Duration of ad libitum meal

    Duration in minutes

    300 minutes

Secondary Outcomes (8)

  • Water intake during ad libitum meal

    300 minutes

  • resting energy expenditure

    Baseline, 90 minutes and 270 minutes

  • Supraclavicular Brown adipose activity

    -15 to 15 , 90 and 270 minutes

  • Appetite and satiety sensations (assessed by VASs),

    Every 15 minutes after infusion, until time-point 90, hereafter every 30 minutes

  • Heart rate

    every 15 minutes from from -15 to 300 minutes

  • +3 more secondary outcomes

Study Arms (2)

Secretin

ACTIVE COMPARATOR
Drug: Secretin

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

SecretinDRUG

Native hormone

Secretin
PlaceboOTHER

Saline

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 75 years
  • Body mass index between 18.5 and 27.5 kg/m2
  • Informed consent
  • Body weight above 50 kg

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev- Gentofte Hospital, Center for Clinical Metabolic Research

Hellerup, Copenhagen, 2900, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 39556772DERIVED

MeSH Terms

Conditions

ObesityMetabolic DiseasesDiabetes Mellitus

Interventions

Secretin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Gastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptide HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Filip K Knop, Professor, MD

    Gentofte Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: randomised, double-blinded, placebo-controlled, cross-over study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2020

First Posted

November 3, 2020

Study Start

March 1, 2020

Primary Completion

September 29, 2020

Study Completion

September 29, 2020

Last Updated

November 5, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)