Obesity
Conditions
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.
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.
Interventions
BIOLOGICALLiver-enriched antimicrobial peptide 2
IV infusion of LEAP2, 2 hours
Sponsors
University Hospital, Gentofte, Copenhagen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study is designed as a clinical study involving one experimental study day.
Eligibility
Sex/Gender
MALE
Age
18 Years to 25 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentrations of LEAP2 | -30 to 270 minutes | Plasma concentrations of LEAP2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Denmark
Outcome results
None listed