NCT01176708

Brief Summary

The aim of the study is to investigate the significance of intact nerve supply to the liver for the glucagon-like peptide-1 (GLP-1) induced insulin secretion. The hypothesis is that the effects of GLP-1 is transmitted through the GLP-1 receptor and that these effects involve sensory afferent neurons, probably primarily parasympathetic.

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 Jul 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

July 1, 2009

Completed
1.1 years 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
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 6, 2012

Status Verified

January 1, 2012

Enrollment Period

3.1 years

First QC Date

August 5, 2010

Last Update Submit

January 5, 2012

Conditions

Liver Transplantation

Keywords

liver transplantationkidney transplantedglucagon-like peptide-1insulin secretionvagotomy

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 (6)

  • plasma glucose

    20 time points within four hours

  • 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

  • +1 more secondary outcomes

Study Arms (3)

Liver transplanted

EXPERIMENTAL

10 Liver transplanted patients

Drug: dipeptidyl peptidase 4 (DPP4) inhibitorOther: oral glucoseOther: intravenous glucose

Kidney transplanted

EXPERIMENTAL

10 kidney transplanted individuals

Drug: dipeptidyl peptidase 4 (DPP4) inhibitorOther: oral glucoseOther: intravenous glucose

Healthy controls

EXPERIMENTAL

10 healthy controls

Drug: dipeptidyl peptidase 4 (DPP4) inhibitorOther: oral glucoseOther: intravenous glucose

Interventions

dipeptidyl peptidase 4 (DPP4) 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
Healthy controlsKidney transplantedLiver transplanted
oral glucoseOTHER

50 grams glucose dissolved in 300 ml water with 1.5 grams paracetamol

Also known as: Panodil
Healthy controlsKidney transplantedLiver transplanted
intravenous glucoseOTHER

1.5 g paracetamol dissolved in 50 ml water is to be ingested orally within the first 2 minutes. Intravenous glucose is supplied in an amount to match the plasma glucose during the oral glucose tolerance test

Also known as: Panodil
Healthy controlsKidney transplantedLiver transplanted

Eligibility Criteria

Age18 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

Hellerup, Copenhagen, 2900, Denmark

RECRUITING

MeSH Terms

Interventions

Dipeptidyl Peptidase 4VildagliptinGlucoseGlucose Tolerance Test

Intervention Hierarchy (Ancestors)

Dipeptidyl-Peptidases and Tripeptidyl-PeptidasesExopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesAntigens, Differentiation, T-LymphocyteAntigens, DifferentiationAntigens, SurfaceAntigensBiological FactorsBiomarkersNitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHexosesMonosaccharidesSugarsCarbohydratesBlood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Central Study Contacts

Astrid Plamboeck, M.D.

CONTACT

+45 26208174astridp@sund.ku.dk

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

July 1, 2009

Primary Completion

August 1, 2012

Study Completion

December 1, 2012

Last Updated

January 6, 2012

Record last verified: 2012-01

Locations

DK(1)