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

Not Applicable
Conditions
Vagotomy, Truncal
Interventions
Other: Saline
Registration Number
NCT01176890
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 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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
30
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
VagoGLP-1Truncally vagotomized subjects (due to duodenal ulcer operation)
VagoSalineTruncally vagotomized subjects (due to duodenal ulcer operation)
CardiaSalinetruncally vagotomized subjects (due to esophagus resection)
Healthy controlsGLP-1Healthy control subjects
Healthy controlsSalineHealthy control subjects
CardiaGLP-1truncally vagotomized subjects (due to esophagus resection)
Primary Outcome Measures
NameTimeMethod
Gastric emptyingfour hours

Gastric emptying will be assessed using a liquid meal with 1.5 g paracetamol added and continuous blood sampling for measuring paracetamol concentration during four hours

Appetitefour hours

Hunger, satiation, and fullness will be assessed before, during and after a liquid meal with 1.5 g paracetamol added using a visual analog scale (VAS)

Food intakefive hours

After the liquid meal test, the volunteers will be offered a meal to assessed their ad libitum food intake

Secondary Outcome Measures
NameTimeMethod
plasma glucosefour hours
serum insulin and c-peptidefour hours
plasma glucagonfour hours
plasma GLP-1four hours
endogenous GLP-1four hours

endogenous GLP-1 will be assessed as plasma GLP-2 concentration

plasma GIPfour hours
serum paracetamolfour hours

Trial Locations

Locations (1)

Department of Internal Medicine F' laboratory

🇩🇰

Hellerup, Copenhagen, Denmark

Department of Internal Medicine F' laboratory
🇩🇰Hellerup, Copenhagen, Denmark
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