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Glucagon-like Peptide 2 - a Glucose Dependent Glucagonotropic Hormone? (GLANCE)

Primary Purpose

Glucose Metabolism Disorders, Endocrine or Metabolic Disease

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Glucagon-like peptide 2
Saline
Glucose
Insulin
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glucose Metabolism Disorders focused on measuring GLP-2, Glucagon

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Center for Clinical Metabolic Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Hyperglycaemia + GLP-2

Hyperglycaemia + Placebo

Hypoglycaemia + GLP-2

Hypoglycaemia + Saline

Euglycaemia + GLP-2

Euglycaemia + Placebo

Arm Description

Glucose + GLP-2

Glucose + saline

Insulin + glucose + GLP-2

Insulin + glucose

GLP-2

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Plasma glucose
Measured in mmol/liter
GLP-1
Glucagon-like peptide 1, Measured in pmol/liter
GLP-2
Glucagon-like peptide 2, Measured in pmol/liter
Insulin
Measured in pmol/liter
GIP
Glucose dependent insulinotropic hormone, Measured in pmol/liter
OXM
Oxytomodulin, Measured in pmol/liter
Amino acids
Measured in pmol/liter
CCK
Cholecystokinin, Measured in pmol/liter
Gastrin
Measured in pmol/liter
FGF-19
Fibroblast Growth factor 19, Measured in ng/mL
FGF-21
Fibroblast Growth factor 21, Measured in ng/mL
Bile acids
Measured in nmol/ml
Norepinephrine
Measured in pmol/liter
GH
Growth hormone, Measured in nmol/ml
P1NP
Procollagen type I N-terminal propeptide (Bonemarker), Measured in nmol/ml
CTX
C-terminal telopeptide (Bonemarker), Measured in nmol/ml
Gallbladder ultrasound
Measuring of gallbladder size in respons to GLP-2
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
Blood pressure
Systolic (mmHg) and diastolic (mmHg) blood pressure in respons to GLP-2
Heart rate
Heart rate (beats/minutes) in respons to GLP-2
C-peptide
Measured in pmol/liter

Full Information

First Posted
May 15, 2019
Last Updated
November 3, 2020
Sponsor
University Hospital, Gentofte, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT03954873
Brief Title
Glucagon-like Peptide 2 - a Glucose Dependent Glucagonotropic Hormone?
Acronym
GLANCE
Official Title
Glucagon-like Peptide 2 - a Glucose Dependent Glucagonotropic Hormone?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 31, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gentofte, Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Metabolism Disorders, Endocrine or Metabolic Disease
Keywords
GLP-2, Glucagon

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filip Krag Knop, MD, PhD
Organizational Affiliation
Center for Clinical Metabolic Research
Official's Role
Study Director
Facility Information:
Facility Name
Center for Clinical Metabolic Research
City
Hellerup
State/Province
Copenhagen
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared with other researchers unless data management agreements are signed.

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

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