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

Glucose Metabolism Disorders Clinical Trial

— GLANCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03954873
• Other study ID #: H-18046965
• Status: Completed
• Phase: N/A
• Start date: January 31, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: November 2020
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Endocrine or Metabolic Disease
• Glucose Metabolism Disorders
• Metabolic Diseases

Intervention

Other:
• Glucagon-like peptide 2
Human glucagon-like peptide 2
• Saline
Placebo
• Glucose
20% (w/v) glucose infusion for regulating plasma glucose
• Insulin
Actrapid (insulin) for lowering plasma glucose

Locations

Country	Name	City	State
Denmark	Center for Clinical Metabolic Research	Hellerup	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucagon secretion	Assessed by difference in absolute plasma glucagon concentrations (measured in pmol/liter) and incremental (baseline-subtracted) area under curve (AUC) for plasma glucagon	110 minutes
Secondary	Plasma glucose	Measured in mmol/liter	110 minutes
Secondary	GLP-1	Glucagon-like peptide 1, Measured in pmol/liter	110 minutes
Secondary	GLP-2	Glucagon-like peptide 2, Measured in pmol/liter	110 minutes
Secondary	Insulin	Measured in pmol/liter	110 minutes
Secondary	GIP	Glucose dependent insulinotropic hormone, Measured in pmol/liter	110 minutes
Secondary	OXM	Oxytomodulin, Measured in pmol/liter	110 minutes
Secondary	Amino acids	Measured in pmol/liter	110 minutes
Secondary	CCK	Cholecystokinin, Measured in pmol/liter	110 minutes
Secondary	Gastrin	Measured in pmol/liter	110 minutes
Secondary	FGF-19	Fibroblast Growth factor 19, Measured in ng/mL	110 minutes
Secondary	FGF-21	Fibroblast Growth factor 21, Measured in ng/mL	110 minutes
Secondary	Bile acids	Measured in nmol/ml	110 minutes
Secondary	Norepinephrine	Measured in pmol/liter	110 minutes
Secondary	GH	Growth hormone, Measured in nmol/ml	110 minutes
Secondary	P1NP	Procollagen type I N-terminal propeptide (Bonemarker), Measured in nmol/ml	110 minutes
Secondary	CTX	C-terminal telopeptide (Bonemarker), Measured in nmol/ml	110 minutes
Secondary	Gallbladder ultrasound	Measuring of gallbladder size in respons to GLP-2	110 minutes
Secondary	Glucose infusion	Amount of glucose infusion (20% v/w) in milliliters needed to clamp at isoglycemic levels (hyperglycemia and hypoglycemia) in respons to GLP-2	90 minutes
Secondary	Blood pressure	Systolic (mmHg) and diastolic (mmHg) blood pressure in respons to GLP-2	110 minutes
Secondary	Heart rate	Heart rate (beats/minutes) in respons to GLP-2	110 minutes
Secondary	C-peptide	Measured in pmol/liter	110 minutes