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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02584582
Acronym
ALFA-1
Enrollment
10
Registered
2015-10-22
Start date
2015-07-31
Completion date
Unknown
Last updated
2015-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

Glucagon, Glukagon-like peptide-1 (GLP-1), GLP-1 receptor agonist (GLP-1RA), Incretins

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.

Interventions

DRUGLiraglutide
DRUGExenatide
PROCEDURELiquid meal test
OTHERNo drug (Baseline day)

Sponsors

Hvidovre University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Glucagon concentration (postprandial)4 hoursglucagon area under the curve (AUC) (0-240 minutes) and baseline to peak increments will be calculated

Secondary

MeasureTime frameDescription
glucagon-like peptide-1 (GLP-1)4 hoursGLP-1 AUC (0-240 minutes) and baseline to peak increments will be calculated
glucagon-like peptide-2 (GLP-2)4 hoursGLP-2 AUC (0-240 minutes) and baseline to peak increments will be calculated
glucose-dependent insulinotropic polypeptide (GIP)4 hoursGIP AUC (0-240 minutes) and baseline to peak increments will be calculated
Cholecystokinin (CCK)4 hoursCCKAUC (0-240 minutes) and baseline to peak increments will be calculated
Peptide YY (PYY)4 hoursPYY AUC (0-240 minutes) and baseline to peak increments will be calculated
Postprandial glucose concentrations4 hoursglucose AUC (0-240 minutes) and baseline to peak increments will be calculated
Gastrin4 hoursGastrin AUC (0-240 minutes) and baseline to peak increments will be calculated
Oxyntomodulin4 hoursOxyntomodulin AUC (0-240 minutes) and baseline to peak increments will be calculated
Free fatty acids (FFA)4 hoursFFA AUC (0-240 minutes) and baseline to peak increments will be calculated
triacylglycerol (TAG)4 hoursTAG AUC (0-240 minutes) and baseline to peak increments will be calculated
Ghrelin4 hoursGhrelin AUC (0-240 minutes) and baseline to peak increments will be calculated

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026