Liver-enriched Antimicrobial Peptide 2

NCT04043065 | Completed Early Phase 1 DMC

• 1 other identifier: LEAP-2
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to investigate the physiological importance of LEAP-2 in healthy volunteers focusing on its potential insulinotropic effects.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Plasma insulin

  Difference in plasma insulin levels

  -45 to 180 minutes

• Beta-cell secretion

  Beta-cell secretion assessed by plasma C-peptide concentration relative to plasma glucose concentration

  -45 to 180 minutes

Secondary Outcomes (3)

• LEAP-2

  -45 to 210 minutes

• Resting energy expenditure

  -20 to 160 minutes

• Appetite, satiety, and general well-being

  -45 to 210 minutes

Study Arms (2)

LEAP-2

EXPERIMENTAL

Liver-enriched antimicrobial peptide 2

Biological: Liver-enriched antimicrobial peptide 2

Placebo

PLACEBO COMPARATOR

Saline

Other: Placebo

Interventions

Liver-enriched antimicrobial peptide 2 BIOLOGICAL

Infusion of LEAP-2 during a 180 min grated glucose infusion.

LEAP-2

Placebo OTHER

Saline

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 20-25 kg/m2
• Informed consent

You may not qualify if:

• Anaemia (haemoglobin below normal range)
• ALAT and/or ASAT \>2 times normal values or history of hepatobiliary and/or gastrointestinal disorder(s)
• Nephropathy (serum creatinine above normal range and/or albuminuria)
• Any physical or psychological condition that the investigator evaluates would interfere with trial participation including any acute or chronic illnesses
• Any ongoing medication that the investigator evaluates would interfere with trial participation.
• First- and second-degree relatives with diabetes
• Regular tobacco smoking

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead
• Gubra ApS: collaborator

Study Sites (1)

Center for Clinical Metabolic Research

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Filip K Knop, MD, PhD

  University Hospital, Gentofte, Copenhagen

  STUDY DIRECTOR

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: July 30, 2019
• First Posted: August 2, 2019
• Study Start: January 28, 2019
• Primary Completion: May 20, 2019
• Study Completion: May 20, 2019
• Last Updated: May 26, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)