Trials / Unknown
UnknownNCT05603598
LEAP2 on Postprandial Glucose Metabolism and Food Intake n Obese Males
LEAP2 on Postprandial Glucose Metabolism and Food Intake in Obese Males
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- University Hospital, Gentofte, Copenhagen · Academic / Other
- Sex
- Male
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
The study aims to delineate the effects of the naturally occurring peptide liver-enriched antimicrobial peptide 2 (LEAP-2) on postprandial glucose metabolism and food intake in obese volunteers. The overall objective is to investigate the physiological importance of LEAP-2 in obese 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. Our group recently found a 12 % relative reduction in ad libitum food intake and reduced postprandial glucose excursions. The present 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 obese subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LEAP-2 Protein, Human | Intravenous infusion, mixed meal test, ad libitum meal test |
Timeline
- Start date
- 2022-08-24
- Primary completion
- 2023-05-01
- Completion
- 2023-05-01
- First posted
- 2022-11-02
- Last updated
- 2022-11-02
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT05603598. Inclusion in this directory is not an endorsement.