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Status unknownNCT01176760Updated Dec 7, 2012

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

An interventional study of Dipeptidyl peptidase 4 (DPP 4) inhibitor and oral glucose in Vagotomy, Truncal, sponsored by University Hospital, Gentofte, Copenhagen. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 90 Years, 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this record recently (last verified Dec 2012), so the status shown — last known as Active, not recruiting — may be out of date.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 to 90 Years
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 glucose and Glucagon-like peptide-1 (GLP-1) in respect to insulin secretion.

The hypothesis is that a great deal of the effects of GLP-1 is mediated via the nervous system and for this reason the investigators will research 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 glucose and GLP-1 on the insulin secretion

02

Conditions studied

  • Vagotomy, Truncal

Keywords

  • vagotomy
  • vagus
  • GLP-1
  • Insulin secretion
03

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 to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • normal fasting plasma glucose
  • normal hemoglobin
  • informed consent

Exclusion criteria

Exclusion Criteria:

  • type 1 diabetes mellitus or type 2 diabetes mellitus
  • body mass index > 30
  • inflammatory bowel disease
  • intestinal surgery
  • serum creatinine > 250 µM and/or albuminuria
  • ALAT > 2 x normal value
  • Severe cardiac insufficiency
  • in 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: Dipeptidyl peptidase 4 (DPP 4) inhibitor · Other: oral glucose

  • Experimental
    Cardia

    Truncally vagotomized subjects (due to cardia resection)

    Drug: Dipeptidyl peptidase 4 (DPP 4) inhibitor · Other: oral glucose

  • Experimental
    Ctrl

    Healthy matched control subjects

    Drug: Dipeptidyl peptidase 4 (DPP 4) inhibitor · Other: oral glucose

Interventions

  • DrugDipeptidyl peptidase 4 (DPP 4) inhibitor

    One tablet (50 mg)of DPP4 inhibitor is to be taken 12 and 1 hours before start of the oral glucose tolerance test (50 g glucose and 1.5 g paracetamol dissolved in 300 ml water)on day 3

    Also known as: Galvus

  • Otheroral glucose

    50 g glucose dissolved in 300 ml water with 1,5 g paracetamol is to be ingested orally within the first 15 minutes.

    Also known as: panodil

06

What researchers measure

Primary outcomes

  1. insulin secretion

    The insulin secretion during a four-hour oral glucose tolerance test (OGTT) and an intravenous isoglycaemic clamp is evaluated

    Time frame: four hours

Secondary outcomes

  1. plasma GLP-1

    12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour

    Time frame: 12 time points within four hours

  2. plasma GIP

    12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour

    Time frame: 12 time points within four hours

  3. plasma glucagon

    12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour

    Time frame: 12 time points within four hours

  4. plasma GLP-2

    12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour

    Time frame: 12 time points within four hours

  5. plasma PYY

    12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour

    Time frame: 12 time points within four hours

07

Study locations

1 site
  • Department of internal medicine F´laboratory, Gentofte Hospital
    Hellerup, Copenhagen 2900, Denmark
08

References and documents

Publications

  • Plamboeck A, Veedfald S, Deacon CF, Hartmann B, Wettergren A, Svendsen LB, Meisner S, Hovendal C, Knop FK, Vilsboll T, Holst JJ. Characterisation of oral and i.v. glucose handling in truncally vagotomised subjects with pyloroplasty. Eur J Endocrinol. 2013 Jul 6;169(2):187-201. doi: 10.1530/EJE-13-0264. Print 2013 Aug. PubMed 23704713 ↗
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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
NCT01176760
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
Aug 2009
Primary completion
Oct 2011
Completion
Dec 2012 (estimated)
Last update
Dec 7, 2012

Study contacts

Astrid Plamboeck, MD
principal investigator · University Hospital, Gentofte, Copenhagen
Tina Vilsbøll, MD, dr.med
study director · University Hospital, Gentofte, Copenhagen

Oversight

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

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