Clinical trial NCT01176890: Intact Vagal Innervation and Glucagon-like Peptide-1 (GLP-1) Effects
Official title: The Significance of Intact Vagal Innervation for the GLP-1 Induced Inhibition of Gastric Emptying, Appetite and Food Intake
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vagotomy, Truncal
Keywords: truncal vagotomy
GLP-1
gastric emptying
appetite
food intake
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2010-08-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

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 GLP-1 on the food intake, gastric emptying (GE) and appetite.

Eligibility criteria: 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

Primary outcomes:
measure: Gastric emptying
timeFrame: four hours
measure: Appetite
timeFrame: four hours
measure: Food intake
timeFrame: five hours
Secondary outcomes:
measure: plasma glucose
timeFrame: four hours
measure: serum insulin and c-peptide
timeFrame: four hours
measure: plasma glucagon
timeFrame: four hours
measure: plasma GLP-1
timeFrame: four hours
measure: endogenous GLP-1
timeFrame: four hours
measure: plasma GIP
timeFrame: four hours
measure: serum paracetamol
timeFrame: four hours
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Department of Internal Medicine F' laboratory
state: Copenhagen
Study officials:
affiliation: University Hospital, Gentofte, Copenhagen
name: Astrid Plamboeck, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Gentofte, Copenhagen
name: Tina Vilsbøll, M.D.
role: STUDY_DIRECTOR
References:
citation: Wewer Albrechtsen NJ, Hartmann B, Veedfald S, Windelov JA, Plamboeck A, Bojsen-Moller KN, Idorn T, Feldt-Rasmussen B, Knop FK, Vilsboll T, Madsbad S, Deacon CF, Holst JJ. Hyperglucagonaemia analysed by glucagon sandwich ELISA: nonspecific interference or truly elevated levels? Diabetologia. 2014 Sep;57(9):1919-26. doi: 10.1007/s00125-014-3283-z. Epub 2014 Jun 3.
citation: Plamboeck A, Veedfald S, Deacon CF, Hartmann B, Wettergren A, Svendsen LB, Meisner S, Hovendal C, Vilsboll T, Knop FK, Holst JJ. The effect of exogenous GLP-1 on food intake is lost in male truncally vagotomized subjects with pyloroplasty. Am J Physiol Gastrointest Liver Physiol. 2013 Jun 15;304(12):G1117-27. doi: 10.1152/ajpgi.00035.2013. Epub 2013 Apr 18.