Overview

This trial is active, not recruiting.

Condition vagotomy, truncal
Treatments dipeptidyl peptidase 4 (dpp 4) inhibitor, oral glucose
Sponsor University Hospital, Gentofte, Copenhagen
Collaborator University of Copenhagen
Start date August 2009
End date October 2011
Trial size 30 participants
Trial identifier NCT01176760, Truncated isoglycemia

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacodynamics study
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Truncally vagotomized subjects (due to duodenal ulcer operation)
dipeptidyl peptidase 4 (dpp 4) inhibitor Galvus
One tablet (50 mg)of DPP4 inhibitor is to be taken 12 and 1 hours before start of the oral glucose tolerance test (50 g glucose and 1.5 g paracetamol dissolved in 300 ml water)on day 3
oral glucose panodil
50 g glucose dissolved in 300 ml water with 1,5 g paracetamol is to be ingested orally within the first 15 minutes.
(Experimental)
Truncally vagotomized subjects (due to cardia resection)
dipeptidyl peptidase 4 (dpp 4) inhibitor Galvus
One tablet (50 mg)of DPP4 inhibitor is to be taken 12 and 1 hours before start of the oral glucose tolerance test (50 g glucose and 1.5 g paracetamol dissolved in 300 ml water)on day 3
oral glucose panodil
50 g glucose dissolved in 300 ml water with 1,5 g paracetamol is to be ingested orally within the first 15 minutes.
(Experimental)
Healthy matched control subjects
dipeptidyl peptidase 4 (dpp 4) inhibitor Galvus
One tablet (50 mg)of DPP4 inhibitor is to be taken 12 and 1 hours before start of the oral glucose tolerance test (50 g glucose and 1.5 g paracetamol dissolved in 300 ml water)on day 3
oral glucose panodil
50 g glucose dissolved in 300 ml water with 1,5 g paracetamol is to be ingested orally within the first 15 minutes.

Primary Outcomes

Measure
insulin secretion
time frame: four hours

Secondary Outcomes

Measure
plasma GLP-1
time frame: 12 time points within four hours
plasma GIP
time frame: 12 time points within four hours
plasma glucagon
time frame: 12 time points within four hours
plasma GLP-2
time frame: 12 time points within four hours
plasma PYY
time frame: 12 time points within four hours

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

Official title The Significances of Intact Vagal Innervation for the Glucose and GLP1 Induced Insulin Secretion
Principal investigator Astrid Plamboeck, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by University Hospital, Gentofte, Copenhagen.