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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03954873
Recruitment Status : Completed
First Posted : May 17, 2019
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Filip Krag Knop, University Hospital, Gentofte, Copenhagen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Glucose Metabolism Disorders Endocrine or Metabolic Disease Other: Glucagon-like peptide 2 Other: Saline Other: Glucose Other: Insulin Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Glucagon-like Peptide 2 - a Glucose Dependent Glucagonotropic Hormone?
Actual Study Start Date : January 31, 2019
Actual Primary Completion Date : June 1, 2020
Actual Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arms and Interventions
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Arm Intervention/treatment
Experimental: Hyperglycaemia + GLP-2
Glucose + GLP-2
 Other: Glucagon-like peptide 2
Human glucagon-like peptide 2

Other: Glucose
20% (w/v) glucose infusion for regulating plasma glucose
Active Comparator: Hyperglycaemia + Placebo
Glucose + saline
 Other: Saline
Placebo

Other: Glucose
20% (w/v) glucose infusion for regulating plasma glucose
Experimental: Hypoglycaemia + GLP-2
Insulin + glucose + GLP-2
 Other: Glucagon-like peptide 2
Human glucagon-like peptide 2

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

Other: Insulin
Actrapid (insulin) for lowering plasma glucose
Active Comparator: Hypoglycaemia + Saline
Insulin + glucose
 Other: Saline
Placebo

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

Other: Insulin
Actrapid (insulin) for lowering plasma glucose
Experimental: Euglycaemia + GLP-2
GLP-2
 Other: Glucagon-like peptide 2
Human glucagon-like peptide 2
Active Comparator: Euglycaemia + Placebo Other: Saline
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Glucagon secretion [ Time Frame: 110 minutes ]
    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 :
  1. Plasma glucose [ Time Frame: 110 minutes ]
    Measured in mmol/liter

  2. GLP-1 [ Time Frame: 110 minutes ]
    Glucagon-like peptide 1, Measured in pmol/liter

  3. GLP-2 [ Time Frame: 110 minutes ]
    Glucagon-like peptide 2, Measured in pmol/liter

  4. Insulin [ Time Frame: 110 minutes ]
    Measured in pmol/liter

  5. GIP [ Time Frame: 110 minutes ]
    Glucose dependent insulinotropic hormone, Measured in pmol/liter

  6. OXM [ Time Frame: 110 minutes ]
    Oxytomodulin, Measured in pmol/liter

  7. Amino acids [ Time Frame: 110 minutes ]
    Measured in pmol/liter

  8. CCK [ Time Frame: 110 minutes ]
    Cholecystokinin, Measured in pmol/liter

  9. Gastrin [ Time Frame: 110 minutes ]
    Measured in pmol/liter

  10. FGF-19 [ Time Frame: 110 minutes ]
    Fibroblast Growth factor 19, Measured in ng/mL

  11. FGF-21 [ Time Frame: 110 minutes ]
    Fibroblast Growth factor 21, Measured in ng/mL

  12. Bile acids [ Time Frame: 110 minutes ]
    Measured in nmol/ml

  13. Norepinephrine [ Time Frame: 110 minutes ]
    Measured in pmol/liter

  14. GH [ Time Frame: 110 minutes ]
    Growth hormone, Measured in nmol/ml

  15. P1NP [ Time Frame: 110 minutes ]
    Procollagen type I N-terminal propeptide (Bonemarker), Measured in nmol/ml

  16. CTX [ Time Frame: 110 minutes ]
    C-terminal telopeptide (Bonemarker), Measured in nmol/ml

  17. Gallbladder ultrasound [ Time Frame: 110 minutes ]
    Measuring of gallbladder size in respons to GLP-2

  18. Glucose infusion [ Time Frame: 90 minutes ]
    Amount of glucose infusion (20% v/w) in milliliters needed to clamp at isoglycemic levels (hyperglycemia and hypoglycemia) in respons to GLP-2

  19. Blood pressure [ Time Frame: 110 minutes ]
    Systolic (mmHg) and diastolic (mmHg) blood pressure in respons to GLP-2

  20. Heart rate [ Time Frame: 110 minutes ]
    Heart rate (beats/minutes) in respons to GLP-2

  21. C-peptide [ Time Frame: 110 minutes ]
    Measured in pmol/liter


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03954873


Locations
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Denmark
Center for Clinical Metabolic Research
Hellerup, Copenhagen, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
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Study Director: Filip Krag Knop, MD, PhD Center for Clinical Metabolic Research
More Information
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Responsible Party: Filip Krag Knop, Clinical Professor, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT03954873    
Other Study ID Numbers: H-18046965
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers unless data management agreements are signed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Filip Krag Knop, University Hospital, Gentofte, Copenhagen:
GLP-2
Glucagon
Additional relevant MeSH terms:
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Metabolic Diseases
Glucose Metabolism Disorders
Glucagon
Glucagon-Like Peptide 1
Physiological Effects of Drugs
 Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Incretins