Overview

This trial is active, not recruiting.

Condition vagotomy, truncal
Treatments glp-1, saline
Sponsor University Hospital, Gentofte, Copenhagen
Collaborator University of Copenhagen
Start date July 2008
End date August 2011
Trial size 30 participants
Trial identifier NCT01176890, Truncated mealtest (AP)

Summary

The aim of this study is to investigate the role of transmission via the vagal nerve for the effect of Glucagon-like peptide-1 (GLP-1) in respect to gastric emptying, appetite and food intake.

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Truncally vagotomized subjects (due to duodenal ulcer operation)
glp-1 Panodil
1.2 pmol/kg/min GLP-1 will be infused intravenously during the four hour meal test (100 g Ny NAN1 and 1.5 g paracetamol dissolved in 300 ml water) ingested over 10 minutes. After four hours an ad libitum meal will be supplied
saline Panodil
Saline (isotonic NaCl) will be infused intravenously during the four hour meal test (100 g Ny NAN1 and 1.5 g paracetamol dissolved in 300 ml water) ingested over 10 minutes. After four hours an ad libitum meal will be supplied
(Experimental)
truncally vagotomized subjects (due to esophagus resection)
glp-1 Panodil
1.2 pmol/kg/min GLP-1 will be infused intravenously during the four hour meal test (100 g Ny NAN1 and 1.5 g paracetamol dissolved in 300 ml water) ingested over 10 minutes. After four hours an ad libitum meal will be supplied
saline Panodil
Saline (isotonic NaCl) will be infused intravenously during the four hour meal test (100 g Ny NAN1 and 1.5 g paracetamol dissolved in 300 ml water) ingested over 10 minutes. After four hours an ad libitum meal will be supplied
(Experimental)
Healthy control subjects
glp-1 Panodil
1.2 pmol/kg/min GLP-1 will be infused intravenously during the four hour meal test (100 g Ny NAN1 and 1.5 g paracetamol dissolved in 300 ml water) ingested over 10 minutes. After four hours an ad libitum meal will be supplied
saline Panodil
Saline (isotonic NaCl) will be infused intravenously during the four hour meal test (100 g Ny NAN1 and 1.5 g paracetamol dissolved in 300 ml water) ingested over 10 minutes. After four hours an ad libitum meal will be supplied

Primary Outcomes

Measure
Gastric emptying
time frame: four hours
Appetite
time frame: four hours
Food intake
time frame: five hours

Secondary Outcomes

Measure
plasma glucose
time frame: four hours
serum insulin and c-peptide
time frame: four hours
plasma glucagon
time frame: four hours
plasma GLP-1
time frame: four hours
endogenous GLP-1
time frame: four hours
plasma GIP
time frame: four hours
serum paracetamol
time frame: four hours

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - truncal vagotomy - normal hemoglobin - informed consent - Age, gender and weight matched controls - normal hemoglobin - informed consent Exclusion Criteria: - type 1 diabetes mellitus or type 2 diabetes mellitus - body mass index > 30 kg/m2 - inflammatory bowel disease - intestinal resection - nephropathy (serum creatinine > 150 µM and/or albuminuria) - liver disease (ALAT and/or ASAT > 2 x normal value) - treatment with medicine which cannot be paused for 12 hours

Additional Information

Official title The Significance of Intact Vagal Innervation for the GLP-1 Induced Inhibition of Gastric Emptying, Appetite and Food Intake
Principal investigator Astrid Plamboeck, M.D.
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 GLP-1 on the food intake, gastric emptying (GE) and appetite.
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by University Hospital, Gentofte, Copenhagen.