LEAP2 Kinetics in Healthy Individuals

Obesity Clinical Trial

Official title:

The Kinetics of LEAP2 in Man

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04897984
• Other study ID #: LEAP2 kinetics
• Status: Completed
• Phase: Early Phase 1
• Start date: May 24, 2021
• Est. completion date: June 25, 2021

Study information

• Verified date: September 2021
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 25, 2021
• Est. primary completion date: June 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
Denmark	Center for Clinical Metabolic Research	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of LEAP2	Plasma concentrations of LEAP2	-30 to 270 minutes
Secondary	VAS	Visual analogue scales (VASs) assessing appetite, satiety and hunger sensations (from 0 to 10 cm on a scale = from mimimum to maximum sensation)	-30 to 270 minutes