NCT04621409

LEAP2 on Postprandial Glucose Metabolism and Food Intake

Effects of LEAP-2 on Postprandial Glucose Metabolism and Food Intake

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University Hospital, Gentofte, Copenhagen · Academic / Other
• Sex: Male
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

Summary

The study aim to delineate the effects of the naturally occurring peptide liver-enriched antimicrobial peptide 2 (LEAP-2) on postprandial glucose metabolism and food intake in healthy volunteers. The overall objective is to investigate the physiological importance of LEAP-2 in healthy subjects.

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 (LEAP-2), a naturally occurring peptide in humans, was significantly upregulated compared to baseline expression. Interestingly, LEAP-2 was recently shown to antagonize ghrelin function in response to feeding in mice. Moreover, the mature murine LEAP-2 peptide is identical in mice and humans. Thus, LEAP-2 has been identified as an endogenous peptide that may be able to alter feeding behaviour and maintenance of glucose levels during calorie restriction. The study hypothesis is that LEAP-2 alters postprandial glucose metabolism and decreases appetite as well as food intake in relation to a liquid mixed meal and a standardised ad libitum meal compared with saline (placebo) in healthy subjects.

Conditions

• Obesity

Interventions

Type	Name	Description
BIOLOGICAL	Liver-enriched antimicrobial peptide 2	IV infusion of LEAP2, approximately 5 hours
BIOLOGICAL	Placebo	IV infusion of saline, approximately 5 hours

Timeline

• Start date: 2020-11-17
• Primary completion: 2021-02-18
• Completion: 2021-02-18
• First posted: 2020-11-09
• Last updated: 2021-05-26

Locations

1 site across 1 country: Denmark