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

October 21, 2015 updated by: Christan SS Frandsen, MD, Hvidovre University Hospital

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

Aim: To investigate the glucagonostatic effect of glucagon-like peptide-1 (GLP-1) independent of the gastric emptying rate.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liraglutide + Liquid meal test
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)
Drug: Liraglutide
Procedure: Liquid meal test
Experimental: Exenatide + Liquid meal test
Exenatide 10 mcg twice daily for 14 days (5 mcg twice daily for one week, escalated to 10 mcg twice daily after one week)
Drug: Exenatide
Procedure: Liquid meal test
Other: Baseline + Liquid meal test
Baseline day with no additional medication
Procedure: Liquid meal test
Other: No drug (Baseline day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucagon concentration (postprandial)
Time Frame: 4 hours
glucagon area under the curve (AUC) (0-240 minutes) and baseline to peak increments will be calculated
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial glucose concentrations
Time Frame: 4 hours
glucose AUC (0-240 minutes) and baseline to peak increments will be calculated
4 hours
glucagon-like peptide-1 (GLP-1)
Time Frame: 4 hours
GLP-1 AUC (0-240 minutes) and baseline to peak increments will be calculated
4 hours
glucagon-like peptide-2 (GLP-2)
Time Frame: 4 hours
GLP-2 AUC (0-240 minutes) and baseline to peak increments will be calculated
4 hours
glucose-dependent insulinotropic polypeptide (GIP)
Time Frame: 4 hours
GIP AUC (0-240 minutes) and baseline to peak increments will be calculated
4 hours
Cholecystokinin (CCK)
Time Frame: 4 hours
CCKAUC (0-240 minutes) and baseline to peak increments will be calculated
4 hours
Peptide YY (PYY)
Time Frame: 4 hours
PYY AUC (0-240 minutes) and baseline to peak increments will be calculated
4 hours
Ghrelin
Time Frame: 4 hours
Ghrelin AUC (0-240 minutes) and baseline to peak increments will be calculated
4 hours
Gastrin
Time Frame: 4 hours
Gastrin AUC (0-240 minutes) and baseline to peak increments will be calculated
4 hours
Oxyntomodulin
Time Frame: 4 hours
Oxyntomodulin AUC (0-240 minutes) and baseline to peak increments will be calculated
4 hours
Free fatty acids (FFA)
Time Frame: 4 hours
FFA AUC (0-240 minutes) and baseline to peak increments will be calculated
4 hours
triacylglycerol (TAG)
Time Frame: 4 hours
TAG AUC (0-240 minutes) and baseline to peak increments will be calculated
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

August 6, 2015

First Submitted That Met QC Criteria

October 21, 2015

First Posted (Estimate)

October 22, 2015

Study Record Updates

Last Update Posted (Estimate)

October 22, 2015

Last Update Submitted That Met QC Criteria

October 21, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-3-2014-128

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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