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The Effect of GLP-1 on Postprandial Glucagon Secretion Independent of The Gastric Emptying Rate (ALFA-1)

Primary Purpose

Type 1 Diabetes

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Liraglutide
Exenatide
Liquid meal test
No drug (Baseline day)
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Glucagon, Glukagon-like peptide-1 (GLP-1), GLP-1 receptor agonist (GLP-1RA), Incretins

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 1 Diabetes
  • >18 years
  • No residual beta-cell function (stimulated C-peptide < 60 pmol)

Exclusion Criteria:

  • Pancreatitis
  • gastroparesis
  • history of alcohol and/or drug abuse
  • pregnancy and lactation
  • other medical or psychological condition that made the patient unsuitable for study participation according to the investigators´ assessment
  • contraindications to gastroscopy
  • cancer (unless in complete remission > five years)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Other

    Arm Label

    Liraglutide + Liquid meal test

    Exenatide + Liquid meal test

    Baseline + Liquid meal test

    Arm Description

    Liraglutide 1.2 mg once daily for 14 days (0.6 mg/day for one week, escalated to 1.2 mg/day after one week)

    Exenatide 10 mcg twice daily for 14 days (5 mcg twice daily for one week, escalated to 10 mcg twice daily after one week)

    Baseline day with no additional medication

    Outcomes

    Primary Outcome Measures

    Glucagon concentration (postprandial)
    glucagon area under the curve (AUC) (0-240 minutes) and baseline to peak increments will be calculated

    Secondary Outcome Measures

    Postprandial glucose concentrations
    glucose AUC (0-240 minutes) and baseline to peak increments will be calculated
    glucagon-like peptide-1 (GLP-1)
    GLP-1 AUC (0-240 minutes) and baseline to peak increments will be calculated
    glucagon-like peptide-2 (GLP-2)
    GLP-2 AUC (0-240 minutes) and baseline to peak increments will be calculated
    glucose-dependent insulinotropic polypeptide (GIP)
    GIP AUC (0-240 minutes) and baseline to peak increments will be calculated
    Cholecystokinin (CCK)
    CCKAUC (0-240 minutes) and baseline to peak increments will be calculated
    Peptide YY (PYY)
    PYY AUC (0-240 minutes) and baseline to peak increments will be calculated
    Ghrelin
    Ghrelin AUC (0-240 minutes) and baseline to peak increments will be calculated
    Gastrin
    Gastrin AUC (0-240 minutes) and baseline to peak increments will be calculated
    Oxyntomodulin
    Oxyntomodulin AUC (0-240 minutes) and baseline to peak increments will be calculated
    Free fatty acids (FFA)
    FFA AUC (0-240 minutes) and baseline to peak increments will be calculated
    triacylglycerol (TAG)
    TAG AUC (0-240 minutes) and baseline to peak increments will be calculated

    Full Information

    First Posted
    August 6, 2015
    Last Updated
    October 21, 2015
    Sponsor
    Hvidovre University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02584582
    Brief Title
    The Effect of GLP-1 on Postprandial Glucagon Secretion Independent of The Gastric Emptying Rate
    Acronym
    ALFA-1
    Official Title
    The Effect of GLP-1 on Postprandial Glucagon Secretion During Prolonged and Intermittent Stimulation of the GLP-1 Receptor Independent of The Gastric Emptying Rate. A Randomized, Open-label Study in People With Type 1 Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    November 2015 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Aim: To investigate the glucagonostatic effect of glucagon-like peptide-1 (GLP-1) independent of the gastric emptying rate.
    Detailed Description
    Aim: To investigate the glucagonostatic effects of glucagon-like peptide-1 (GLP-1) during prolonged and intermittent stimulation of the GLP-1 receptor independent of the gastric emptying rate. Glucagon concentrations will be measured following a liquid meal administered in duodenum at baseline and after exenatide, and liraglutide treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 1 Diabetes
    Keywords
    Glucagon, Glukagon-like peptide-1 (GLP-1), GLP-1 receptor agonist (GLP-1RA), Incretins

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Liraglutide + Liquid meal test
    Arm Type
    Experimental
    Arm Description
    Liraglutide 1.2 mg once daily for 14 days (0.6 mg/day for one week, escalated to 1.2 mg/day after one week)
    Arm Title
    Exenatide + Liquid meal test
    Arm Type
    Experimental
    Arm Description
    Exenatide 10 mcg twice daily for 14 days (5 mcg twice daily for one week, escalated to 10 mcg twice daily after one week)
    Arm Title
    Baseline + Liquid meal test
    Arm Type
    Other
    Arm Description
    Baseline day with no additional medication
    Intervention Type
    Drug
    Intervention Name(s)
    Liraglutide
    Intervention Type
    Drug
    Intervention Name(s)
    Exenatide
    Intervention Type
    Procedure
    Intervention Name(s)
    Liquid meal test
    Intervention Type
    Other
    Intervention Name(s)
    No drug (Baseline day)
    Primary Outcome Measure Information:
    Title
    Glucagon concentration (postprandial)
    Description
    glucagon area under the curve (AUC) (0-240 minutes) and baseline to peak increments will be calculated
    Time Frame
    4 hours
    Secondary Outcome Measure Information:
    Title
    Postprandial glucose concentrations
    Description
    glucose AUC (0-240 minutes) and baseline to peak increments will be calculated
    Time Frame
    4 hours
    Title
    glucagon-like peptide-1 (GLP-1)
    Description
    GLP-1 AUC (0-240 minutes) and baseline to peak increments will be calculated
    Time Frame
    4 hours
    Title
    glucagon-like peptide-2 (GLP-2)
    Description
    GLP-2 AUC (0-240 minutes) and baseline to peak increments will be calculated
    Time Frame
    4 hours
    Title
    glucose-dependent insulinotropic polypeptide (GIP)
    Description
    GIP AUC (0-240 minutes) and baseline to peak increments will be calculated
    Time Frame
    4 hours
    Title
    Cholecystokinin (CCK)
    Description
    CCKAUC (0-240 minutes) and baseline to peak increments will be calculated
    Time Frame
    4 hours
    Title
    Peptide YY (PYY)
    Description
    PYY AUC (0-240 minutes) and baseline to peak increments will be calculated
    Time Frame
    4 hours
    Title
    Ghrelin
    Description
    Ghrelin AUC (0-240 minutes) and baseline to peak increments will be calculated
    Time Frame
    4 hours
    Title
    Gastrin
    Description
    Gastrin AUC (0-240 minutes) and baseline to peak increments will be calculated
    Time Frame
    4 hours
    Title
    Oxyntomodulin
    Description
    Oxyntomodulin AUC (0-240 minutes) and baseline to peak increments will be calculated
    Time Frame
    4 hours
    Title
    Free fatty acids (FFA)
    Description
    FFA AUC (0-240 minutes) and baseline to peak increments will be calculated
    Time Frame
    4 hours
    Title
    triacylglycerol (TAG)
    Description
    TAG AUC (0-240 minutes) and baseline to peak increments will be calculated
    Time Frame
    4 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Type 1 Diabetes >18 years No residual beta-cell function (stimulated C-peptide < 60 pmol) Exclusion Criteria: Pancreatitis gastroparesis history of alcohol and/or drug abuse pregnancy and lactation other medical or psychological condition that made the patient unsuitable for study participation according to the investigators´ assessment contraindications to gastroscopy cancer (unless in complete remission > five years)

    12. IPD Sharing Statement

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    The Effect of GLP-1 on Postprandial Glucagon Secretion Independent of The Gastric Emptying Rate

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