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

Phase 2
Conditions
Type 1 Diabetes
Interventions
Procedure: Liquid meal test
Other: No drug (Baseline day)
Registration Number
NCT02584582
Lead Sponsor
Hvidovre University Hospital
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
10
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 investigatorsĀ“ assessment
  • contraindications to gastroscopy
  • cancer (unless in complete remission > five years)

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Baseline + Liquid meal testLiquid meal testBaseline day with no additional medication
Baseline + Liquid meal testNo drug (Baseline day)Baseline day with no additional medication
Liraglutide + Liquid meal testLiraglutideLiraglutide 1.2 mg once daily for 14 days (0.6 mg/day for one week, escalated to 1.2 mg/day after one week)
Liraglutide + Liquid meal testLiquid meal testLiraglutide 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 + Liquid meal testLiquid meal testExenatide 10 mcg twice daily for 14 days (5 mcg twice daily for one week, escalated to 10 mcg twice daily after one week)
Exenatide + Liquid meal testExenatideExenatide 10 mcg twice daily for 14 days (5 mcg twice daily for one week, escalated to 10 mcg twice daily after one week)
Primary Outcome Measures
NameTimeMethod
Glucagon concentration (postprandial)4 hours

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

Secondary Outcome Measures
NameTimeMethod
Oxyntomodulin4 hours

Oxyntomodulin AUC (0-240 minutes) and baseline to peak increments will be calculated

Gastrin4 hours

Gastrin AUC (0-240 minutes) and baseline to peak increments will be calculated

Postprandial glucose concentrations4 hours

glucose AUC (0-240 minutes) and baseline to peak increments will be calculated

glucagon-like peptide-1 (GLP-1)4 hours

GLP-1 AUC (0-240 minutes) and baseline to peak increments will be calculated

glucagon-like peptide-2 (GLP-2)4 hours

GLP-2 AUC (0-240 minutes) and baseline to peak increments will be calculated

glucose-dependent insulinotropic polypeptide (GIP)4 hours

GIP AUC (0-240 minutes) and baseline to peak increments will be calculated

Cholecystokinin (CCK)4 hours

CCKAUC (0-240 minutes) and baseline to peak increments will be calculated

Peptide YY (PYY)4 hours

PYY AUC (0-240 minutes) and baseline to peak increments will be calculated

Ghrelin4 hours

Ghrelin AUC (0-240 minutes) and baseline to peak increments will be calculated

Free fatty acids (FFA)4 hours

FFA AUC (0-240 minutes) and baseline to peak increments will be calculated

triacylglycerol (TAG)4 hours

TAG AUC (0-240 minutes) and baseline to peak increments will be calculated

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