An Early Phase 1 interventional study of Liver-enriched antimicrobial peptide 2 and Placebo in Obesity, sponsored by University Hospital, Gentofte, Copenhagen. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-26.
Sponsored by University Hospital, Gentofte, Copenhagen · Early Phase 1, Interventional, and Treatment
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.
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.
University Hospital, Gentofte, Copenhagen is the lead sponsor of 154 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
IV infusion of LEAP2, approximately 5 hours
Biological: Liver-enriched antimicrobial peptide 2
IV infusion of saline, approximately 5 hours
Biological: Placebo
IV infusion of LEAP2, approximately 5 hours
IV infusion of saline, approximately 5 hours
Food intake
Difference in food intake during an ad libitum meal. Food intake is examined as kilojoules (kJ) and kJ/kg body weight of food eaten during the ad libitum meal.
Time frame: 260 to 290 minutes
VAS
Visual analogue scales (VASs) assessing appetite, satiety and hunger sensations (from 0 to 10 cm on a scale = from mimimum to maximum sensation)
Time frame: -30 to 290 minutes
Alterations in gastric emptying
Paracetamol concentration in plasma after intake of 1.5 g paracetamol
Time frame: -30 to 290 minutes
Plasma insulin levels and beta cell secretion assessed by plasma C-peptide concentration relative to plasma glucose concentration
Plasma insulin levels and beta cell secretion assessed by plasma C-peptide concentration relative to plasma glucose concentration
Time frame: -30 to 290 minutes
Plasma/serum concentrations of LEAP-2, acyl-ghrelin as well as other glucose- and appetite-regulating gut hormones
Plasma/serum concentrations of LEAP-2, acyl-ghrelin as well as other glucose- and appetite-regulating gut hormones
Time frame: -30 to 290 minutes
Changes in resting energy expenditure (REE)
Changes in resting energy expenditure (REE) measured by indirect calorimetry
Time frame: -30 to 290 minutes
Assessment of nitrogen balance and protein breakdown in urine
Urine concentrations of urea for assessment of nitrogen balance and protein breakdown
Time frame: -30 to 290 minutes
Triglyceride responses
Plasma triglyceride
Time frame: -30 to 290 minutes
Cholesterol responses
Plasma cholesterol
Time frame: -30 to 290 minutes
Free fatty acid responses
Plasma free fatty acid
Time frame: -30 to 290 minutes
Plan to share: No
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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Gentofte, Copenhagen