LEAP2 on Postprandial Glucose Metabolism and Food Intake

NCT04621409 | Completed Early Phase 1 DMC

• 1 other identifier: LEAP2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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.

  260 to 290 minutes

Secondary Outcomes (9)

• VAS

  -30 to 290 minutes

• Alterations in gastric emptying

  -30 to 290 minutes

• Plasma insulin levels and beta cell secretion assessed by plasma C-peptide concentration relative to plasma glucose concentration

  -30 to 290 minutes

• Plasma/serum concentrations of LEAP-2, acyl-ghrelin as well as other glucose- and appetite-regulating gut hormones

  -30 to 290 minutes

• Changes in resting energy expenditure (REE)

  -30 to 290 minutes

Study Arms (2)

liver-enriched antimicrobial peptide 2

EXPERIMENTAL

IV infusion of LEAP2, approximately 5 hours

Biological: Liver-enriched antimicrobial peptide 2

Placebo

PLACEBO COMPARATOR

IV infusion of saline, approximately 5 hours

Biological: Placebo

Interventions

Liver-enriched antimicrobial peptide 2 BIOLOGICAL

IV infusion of LEAP2, approximately 5 hours

liver-enriched antimicrobial peptide 2

Placebo BIOLOGICAL

IV infusion of saline, approximately 5 hours

Placebo

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Caucasian men
• Age between 18 and 25 years
• Body mass index between 20-35 kg/m2
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Center for Clinical Metabolic Research

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Filip K Knop, MD, PhD

  Center for Clinical Metabolic Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Day A and B will be conducted in a randomised, double-blinded order (blinded for the participant and the investigator) and noted by a third person not participating in the collection or analyses of data. The infusion order will be opened after the primary data analyses.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, head of department

Model Details: The study is designed as a clinical, placebo-controlled, double-blinded cross-over study involving two experimental study days.

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: November 9, 2020
• Study Start: November 17, 2020
• Primary Completion: February 18, 2021
• Study Completion: February 18, 2021
• Last Updated: May 26, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)