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LEAP2 Kinetics in Healthy Individuals

Sponsor
University Hospital, Gentofte, Copenhagen (Other)
Overall Status
Completed
CT.gov ID
NCT04897984
Collaborator
(none)
8
Enrollment
1
Location
1
Arm
1.1
Actual Duration (Months)
7.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to investigate the kinetics of the naturally occurring peptide liver-enriched antimicrobial peptide 2 (LEAP-2) in healthy volunteers. The overall objective is to investigate the physiological importance of LEAP-2 in healthy subjects.

Condition or Disease Intervention/Treatment Phase
  • Biological: Liver-enriched antimicrobial peptide 2
 Early Phase 1

Detailed Description

In a recent study, the molecular phenotype of enteroendocrine cells in the small intestine before and after Roux-en-Y Gastric Bypass (RYGB) surgery in obese individuals was examined. Enteroendocrine cells were identified and isolated from intestinal biopsies and analysed for differentially expressed genes by Illumina High Throughput RNA-sequencing. It was discovered that the gene encoding liver-enriched antimicrobial peptide 2 (LEAP2), a naturally occurring peptide in humans, was significantly upregulated compared to baseline expression. Interestingly, LEAP2 was recently shown to antagonize ghrelin function in response to feeding in mice. Moreover, the mature murine LEAP2 peptide is identical in mice and humans. Thus, LEAP2 has been identified as an endogenous peptide that may be able to alter feeding behaviour and maintenance of glucose levels during calorie restriction.

This study aims to investigate the kinetics of exogenous LEAP2 in healthy subjects.

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
The study is designed as a clinical study involving one experimental study day.The study is designed as a clinical study involving one experimental study day.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Kinetics of LEAP2 in Man
Actual Study Start Date :
May 24, 2021
Actual Primary Completion Date :
Jun 25, 2021
Actual Study Completion Date :
Jun 25, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Liver-enriched antimicrobial peptide 2

IV infusion of LEAP2, 2 hours

Biological: Liver-enriched antimicrobial peptide 2
IV infusion of LEAP2, 2 hours

Outcome Measures

Primary Outcome Measures

  1. Plasma concentrations of LEAP2 [-30 to 270 minutes]

    Plasma concentrations of LEAP2

Secondary Outcome Measures

  1. VAS [-30 to 270 minutes]

    Visual analogue scales (VASs) assessing appetite, satiety and hunger sensations (from 0 to 10 cm on a scale = from mimimum to maximum sensation)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Caucasian men

  • Age between 18 and 25 years

  • Body mass index between 20-35 kg/m2

  • Informed consent

Exclusion Criteria:

  • Anaemia (haemoglobin below normal range)

  • Alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) >2 times normal values) or history of hepatobiliary and/or gastrointestinal disorder(s)

  • Nephropathy (serum creatinine above normal range and/or albuminuria)

  • Allergy or intolerance to ingredients included in the standardised meals

  • First-degree relatives with diabetes and/or glycated haemoglobin (HbA1c) >48 mmol/mol

  • Regular tobacco smoking or use of other nicotine-containing products

  • Any ongoing medication that the investigator evaluates would interfere with trial participation.

  • Any physical or psychological condition that the investigator evaluates would interfere with trial participation including any acute or chronic illnesses

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center for Clinical Metabolic Research Hellerup Denmark 2900

Sponsors and Collaborators

  • University Hospital, Gentofte, Copenhagen

Investigators

  • Principal Investigator: Filip K Knop, MD, PhD, Center for Clinical Metabolic Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Filip Krag Knop, Professor, head of department, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT04897984
Other Study ID Numbers:
  • LEAP2 kinetics
First Posted:
May 24, 2021
Last Update Posted:
Sep 28, 2021
Last Verified:
Sep 1, 2021
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:
Anti-Infective Agents
Anti-Bacterial Agents

Study Results

No Results Posted as of Sep 28, 2021