NCT01176760

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 7, 2012

Status Verified

December 1, 2012

Enrollment Period

2.2 years

First QC Date

August 5, 2010

Last Update Submit

December 6, 2012

Conditions

Vagotomy, Truncal

Keywords

vagotomyvagusGLP-1Insulin secretion

Outcome Measures

Primary Outcomes (1)

  • insulin secretion

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

    four hours

Secondary Outcomes (5)

  • plasma GLP-1

    12 time points within four hours

  • plasma GIP

    12 time points within four hours

  • plasma glucagon

    12 time points within four hours

  • plasma GLP-2

    12 time points within four hours

  • plasma PYY

    12 time points within four hours

Study Arms (3)

Vago

EXPERIMENTAL

Truncally vagotomized subjects (due to duodenal ulcer operation)

Drug: Dipeptidyl peptidase 4 (DPP 4) inhibitorOther: oral glucose

Cardia

EXPERIMENTAL

Truncally vagotomized subjects (due to cardia resection)

Drug: Dipeptidyl peptidase 4 (DPP 4) inhibitorOther: oral glucose

Ctrl

EXPERIMENTAL

Healthy matched control subjects

Drug: Dipeptidyl peptidase 4 (DPP 4) inhibitorOther: oral glucose

Interventions

Dipeptidyl peptidase 4 (DPP 4) inhibitorDRUG

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
CardiaCtrlVago
oral glucoseOTHER

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
CardiaCtrlVago

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • normal fasting plasma glucose
  • normal hemoglobin
  • informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of internal medicine F´laboratory, Gentofte Hospital

Hellerup, Copenhagen, 2900, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 23704713DERIVED

MeSH Terms

Interventions

Dipeptidyl Peptidase 4VildagliptinGlucose

Intervention Hierarchy (Ancestors)

Dipeptidyl-Peptidases and Tripeptidyl-PeptidasesExopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesAntigens, Differentiation, T-LymphocyteAntigens, DifferentiationAntigens, SurfaceAntigensBiological FactorsBiomarkersNitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Astrid Plamboeck, MD

    University Hospital, Gentofte, Copenhagen

    PRINCIPAL INVESTIGATOR

  • Tina Vilsbøll, MD, dr.med

    University Hospital, Gentofte, Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 5, 2010

First Posted

August 6, 2010

Study Start

August 1, 2009

Primary Completion

October 1, 2011

Study Completion

December 1, 2012

Last Updated

December 7, 2012

Record last verified: 2012-12

Locations

DK(1)