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

The Significance of Intact Vagal Innervation for the GLP-1 Induced Inhibition of Gastric Emptying, Appetite and Food Intake

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01176890
Enrollment
30
Registered
2010-08-06
Start date
2008-07-31
Completion date
2012-12-31
Last updated
2012-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vagotomy, Truncal

Keywords

truncal vagotomy, GLP-1, gastric emptying, appetite, food intake

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.

Interventions

DRUGGLP-1

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

OTHERSaline

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

Sponsors

University of Copenhagen
CollaboratorOTHER
University Hospital, Gentofte, Copenhagen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Gastric emptyingfour hoursGastric 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 hoursHunger, 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 hoursAfter the liquid meal test, the volunteers will be offered a meal to assessed their ad libitum food intake

Secondary

MeasureTime frameDescription
plasma GLP-1four hours
endogenous GLP-1four hoursendogenous GLP-1 will be assessed as plasma GLP-2 concentration
plasma glucosefour hours
serum paracetamolfour hours
plasma GIPfour hours
serum insulin and c-peptidefour hours
plasma glucagonfour hours

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026