CClinicalTrials.gg
Status unknownNCT01176890Updated Dec 7, 2012

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

An interventional study of GLP-1 and Saline in Vagotomy, Truncal, sponsored by University Hospital, Gentofte, Copenhagen. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-12-07.

Sponsored by University Hospital, Gentofte, Copenhagen · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Dec 2012), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Vagotomy, Truncal

Keywords

  • truncal vagotomy
  • GLP-1
  • gastric emptying
  • appetite
  • food intake
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In context

Lead sponsor

University Hospital, Gentofte, Copenhagen is the lead sponsor of 154 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • truncal vagotomy
  • normal hemoglobin
  • informed consent
  • Age, gender and weight matched controls
  • normal hemoglobin
  • informed consent

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Vago

    Truncally vagotomized subjects (due to duodenal ulcer operation)

    Drug: GLP-1 · Other: Saline

  • Experimental
    Cardia

    truncally vagotomized subjects (due to esophagus resection)

    Drug: GLP-1 · Other: Saline

  • Experimental
    Healthy controls

    Healthy control subjects

    Drug: GLP-1 · Other: Saline

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

    Also known as: Panodil

  • 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

    Also known as: Panodil

06

What researchers measure

Primary outcomes

  1. Gastric emptying

    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

    Time frame: four hours

  2. Appetite

    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)

    Time frame: four hours

  3. Food intake

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

    Time frame: five hours

Secondary outcomes

  1. plasma glucose

    Time frame: four hours

  2. serum insulin and c-peptide

    Time frame: four hours

  3. plasma glucagon

    Time frame: four hours

  4. plasma GLP-1

    Time frame: four hours

  5. endogenous GLP-1

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

    Time frame: four hours

  6. plasma GIP

    Time frame: four hours

  7. serum paracetamol

    Time frame: four hours

07

Study locations

1 site
  • Department of Internal Medicine F' laboratory
    Hellerup, Copenhagen 2900, Denmark
08

References and documents

Publications

  • 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. PubMed 24891019 ↗
  • 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. PubMed 23599045 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01176890
Lead sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
University of Copenhagen
Responsible party
Jonatan I Bagger (MD, University Hospital, Gentofte, Copenhagen) — Principal investigator
First posted
Aug 6, 2010
Start date
Jul 2008
Primary completion
Aug 2011
Completion
Dec 2012 (estimated)
Last update
Dec 7, 2012

Study contacts

Astrid Plamboeck, M.D.
principal investigator · University Hospital, Gentofte, Copenhagen
Tina Vilsbøll, M.D.
study director · University Hospital, Gentofte, Copenhagen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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