LEAP2 Kinetics in Healthy Individuals
The Kinetics of LEAP2 in Man
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Tidlig fase 1
Kontakter og lokationer
Studiesteder
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Hellerup, Danmark, 2900
- Center for Clinical Metabolic Research
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Liver-enriched antimicrobial peptide 2
IV infusion of LEAP2, 2 hours
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IV infusion of LEAP2, 2 hours
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Plasma concentrations of LEAP2
Tidsramme: -30 to 270 minutes
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Plasma concentrations of LEAP2
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-30 to 270 minutes
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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VAS
Tidsramme: -30 to 270 minutes
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Visual analogue scales (VASs) assessing appetite, satiety and hunger sensations (from 0 to 10 cm on a scale = from mimimum to maximum sensation)
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-30 to 270 minutes
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Filip K Knop, MD, PhD, Center for Clinical Metabolic Research
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- LEAP2 kinetics
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Liver-enriched antimicrobial peptide 2
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