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Glucagon-like Peptide 2 - a Glucose Dependent Glucagonotropic Hormone?

NCT ID: NCT03954873

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-31

Study Completion Date

2020-06-01

Brief Summary

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Infusion of glucagon-like peptide 2 (GLP-2) during euglycaemia, hypoglycaemia and hyperglycaemia and evaluation of the effect on glucagon secretion in healthy subjects.

Detailed Description

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This is a cross-over, randomized, double-blinded study in which 10 participants will undergo 6 experimental days each. The participants will have their plasma glucose clamped at either euglycaemia (fasting level), hypoglycemia (2,5 mmol/l) or hyperglycemia (10 mmol/l) during infusion of GLP-2 or saline (placebo)

The six days will be as follows:

* Euglycaemia + Placebo
* Euglycaemia + GLP-2
* Hyperglycaemia + Placebo
* Hyperglycaemia + GLP-2
* Hypoglycaemia + Placebo
* Hypoglycaemia + GLP-2

The primary endpoint will be levels of plasma glucagon. Secondary endpoint will be levels of GLP-1, GLP-2, Insulin/C-peptide, OXM, Amino acids, CCK, Gastrin, norepinephrine, bile acids, FGF-19/FGF-21. Secondary endpoints will also include ultrasound scan of the gallbladder.

Conditions

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Glucose Metabolism Disorders Endocrine or Metabolic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Hyperglycaemia + GLP-2

Glucose + GLP-2

Group Type EXPERIMENTAL

Glucagon-like peptide 2

Intervention Type OTHER

Human glucagon-like peptide 2

Glucose

Intervention Type OTHER

20% (w/v) glucose infusion for regulating plasma glucose

Hyperglycaemia + Placebo

Glucose + saline

Group Type ACTIVE_COMPARATOR

Saline

Intervention Type OTHER

Placebo

Glucose

Intervention Type OTHER

20% (w/v) glucose infusion for regulating plasma glucose

Hypoglycaemia + GLP-2

Insulin + glucose + GLP-2

Group Type EXPERIMENTAL

Glucagon-like peptide 2

Intervention Type OTHER

Human glucagon-like peptide 2

Glucose

Intervention Type OTHER

20% (w/v) glucose infusion for regulating plasma glucose

Insulin

Intervention Type OTHER

Actrapid (insulin) for lowering plasma glucose

Hypoglycaemia + Saline

Insulin + glucose

Group Type ACTIVE_COMPARATOR

Saline

Intervention Type OTHER

Placebo

Glucose

Intervention Type OTHER

20% (w/v) glucose infusion for regulating plasma glucose

Insulin

Intervention Type OTHER

Actrapid (insulin) for lowering plasma glucose

Euglycaemia + GLP-2

GLP-2

Group Type EXPERIMENTAL

Glucagon-like peptide 2

Intervention Type OTHER

Human glucagon-like peptide 2

Euglycaemia + Placebo

Group Type ACTIVE_COMPARATOR

Saline

Intervention Type OTHER

Placebo

Interventions

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Glucagon-like peptide 2

Human glucagon-like peptide 2

Intervention Type OTHER

Saline

Placebo

Intervention Type OTHER

Glucose

20% (w/v) glucose infusion for regulating plasma glucose

Intervention Type OTHER

Insulin

Actrapid (insulin) for lowering plasma glucose

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Caucasian ethnicity
* Body mass index (BMI): 18.5-27 kg/m2
* Glycated haemoglobin (HbA1c) \< 42 mmol/mol
* Normal haemoglobin (8.3-10.5 mmol/l)
* Informed and oral and written consent

Exclusion Criteria

* Prediabetes, type 1 diabetes or type 2 diabetes or first-degree relatives with type 1 or type 2 diabetes
* Nephropathy (eGFR \< 60 and/or albuminuria)
* Known liver disease and/or alanine transaminase (ALAT) or aspartate transaminase (ASAT) \> 2 × upper normal limit
* Bilirubin \> 25 μmol/l
* Known intestinal disease or previous surgery of the intestines
* Active or recent malignant disease
* Treatment with medicine that cannot be paused for 12 hours
* Any condition considered incompatible with participation by the investigators
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Filip Krag Knop

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Filip Krag Knop, MD, PhD

Role: STUDY_DIRECTOR

Center for Clinical Metabolic Research

Locations

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Center for Clinical Metabolic Research

Hellerup, Copenhagen, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-18046965

Identifier Type: -

Identifier Source: org_study_id