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
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
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
NCT ID
NCT02584582
First Posted
August 6, 2015
Last Updated
October 21, 2015
Sponsor
Hvidovre University Hospital
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
Learn more about this trial
The Effect of GLP-1 on Postprandial Glucagon Secretion Independent of The Gastric Emptying Rate
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