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

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

Sponsors

Lead Sponsor: University Hospital, Gentofte, Copenhagen

Source University Hospital, Gentofte, Copenhagen
Brief Summary

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

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.

Overall Status Active, not recruiting
Start Date January 31, 2019
Completion Date May 29, 2020
Primary Completion Date May 29, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Glucagon secretion 110 minutes
Secondary Outcome
Measure Time Frame
Plasma glucose 110 minutes
GLP-1 110 minutes
GLP-2 110 minutes
Insulin 110 minutes
GIP 110 minutes
OXM 110 minutes
Amino acids 110 minutes
CCK 110 minutes
Gastrin 110 minutes
FGF-19 110 minutes
FGF-21 110 minutes
Bile acids 110 minutes
Norepinephrine 110 minutes
GH 110 minutes
P1NP 110 minutes
CTX 110 minutes
Gallbladder ultrasound 110 minutes
Glucose infusion 90 minutes
Blood pressure 110 minutes
Heart rate 110 minutes
C-peptide 110 minutes
Enrollment 10
Condition
Intervention

Intervention Type: Other

Intervention Name: Glucagon-like peptide 2

Description: Human glucagon-like peptide 2

Intervention Type: Other

Intervention Name: Saline

Description: Placebo

Intervention Type: Other

Intervention Name: Glucose

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

Intervention Type: Other

Intervention Name: Insulin

Description: Actrapid (insulin) for lowering plasma glucose

Eligibility

Criteria:

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

Gender: Male

Minimum Age: 18 Years

Maximum Age: 40 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Filip Krag Knop, MD, PhD Study Director Center for Clinical Metabolic Research
Location
Facility: Center for Clinical Metabolic Research
Location Countries

Denmark

Verification Date

August 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University Hospital, Gentofte, Copenhagen

Investigator Full Name: Filip Krag Knop

Investigator Title: Clinical Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 6
Arm Group

Label: Hyperglycaemia + GLP-2

Type: Experimental

Description: Glucose + GLP-2

Label: Hyperglycaemia + Placebo

Type: Active Comparator

Description: Glucose + saline

Label: Hypoglycaemia + GLP-2

Type: Experimental

Description: Insulin + glucose + GLP-2

Label: Hypoglycaemia + Saline

Type: Active Comparator

Description: Insulin + glucose

Label: Euglycaemia + GLP-2

Type: Experimental

Description: GLP-2

Label: Euglycaemia + Placebo

Type: Active Comparator

Acronym GLANCE
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Basic Science

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov