Intact Vagal Innervation for and Glucagon-like Peptide-1 (GLP-1) Effects

Not Applicable

• Conditions: Vagotomy, Truncal
• Interventions: Drug: Dipeptidyl peptidase 4 (DPP 4) inhibitor; Other: oral glucose

• Registration Number: NCT01176760
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

Brief Summary

The aim of this study is to investigate the role of transmission via the vagal nerve for the effect of glucose and Glucagon-like peptide-1 (GLP-1) in respect to insulin secretion.

The hypothesis is that a great deal of the effects of GLP-1 is mediated via the nervous system and for this reason the investigators will research individuals with and without intact nervous supply.

Detailed Description

GLP-1 is a potent enterogastron and incretin hormone. It is rapidly inactivated by dipeptidyl peptidase IV so only 10-15% enters the systemic circulation. This has led to the hypothesis that GLP-1 interact locally with afferent sensory nerve fibers. We investigated the role of intact vagal innervations on the effect of glucose and GLP-1 on the insulin secretion

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-08-05
• Study First Submitted QC: 2010-08-05
• Study First Posted: 2010-08-06
• Primary Completion: 2011-10
• Status Verified: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-06
• Last Update Posted: 2012-12-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• normal fasting plasma glucose
• normal hemoglobin
• informed consent

Exclusion Criteria

• type 1 diabetes mellitus or type 2 diabetes mellitus
• body mass index > 30
• inflammatory bowel disease
• intestinal surgery
• serum creatinine > 250 µM and/or albuminuria
• ALAT > 2 x normal value
• Severe cardiac insufficiency
• in treatment with medicine which cannot be paused for 12 hours

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardia	oral glucose	Truncally vagotomized subjects (due to cardia resection)
Vago	Dipeptidyl peptidase 4 (DPP 4) inhibitor	Truncally vagotomized subjects (due to duodenal ulcer operation)
Vago	oral glucose	Truncally vagotomized subjects (due to duodenal ulcer operation)
Cardia	Dipeptidyl peptidase 4 (DPP 4) inhibitor	Truncally vagotomized subjects (due to cardia resection)
Ctrl	Dipeptidyl peptidase 4 (DPP 4) inhibitor	Healthy matched control subjects
Ctrl	oral glucose	Healthy matched control subjects

Primary Outcome Measures

Name	Time	Method
insulin secretion	four hours	The insulin secretion during a four-hour oral glucose tolerance test (OGTT) and an intravenous isoglycaemic clamp is evaluated

Secondary Outcome Measures

Name	Time	Method
plasma GLP-1	12 time points within four hours	12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour
plasma GIP	12 time points within four hours	12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour
plasma glucagon	12 time points within four hours	12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour
plasma GLP-2	12 time points within four hours	12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour
plasma PYY	12 time points within four hours	12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour

Trial Locations

Locations (1)

Department of internal medicine F´laboratory, Gentofte Hospital; 🇩🇰 Hellerup, Copenhagen, Denmark