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

NCT ID: NCT01176760

Last Updated: 2012-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Vagotomy, Truncal

Keywords

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vagotomy vagus GLP-1 Insulin secretion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Vago

Truncally vagotomized subjects (due to duodenal ulcer operation)

Group Type EXPERIMENTAL

Dipeptidyl peptidase 4 (DPP 4) inhibitor

Intervention Type DRUG

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

oral glucose

Intervention Type OTHER

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

Cardia

Truncally vagotomized subjects (due to cardia resection)

Group Type EXPERIMENTAL

Dipeptidyl peptidase 4 (DPP 4) inhibitor

Intervention Type DRUG

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

oral glucose

Intervention Type OTHER

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

Ctrl

Healthy matched control subjects

Group Type EXPERIMENTAL

Dipeptidyl peptidase 4 (DPP 4) inhibitor

Intervention Type DRUG

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

oral glucose

Intervention Type OTHER

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

Interventions

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Dipeptidyl 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

Intervention Type DRUG

oral glucose

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

Intervention Type OTHER

Other Intervention Names

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Galvus panodil

Eligibility Criteria

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Inclusion Criteria

* normal fasting plasma glucose
* normal hemoglobin
* informed consent

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Jonatan I Bagger

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Astrid Plamboeck, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Gentofte, Copenhagen

Tina Vilsbøll, MD, dr.med

Role: STUDY_DIRECTOR

University Hospital, Gentofte, Copenhagen

Locations

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Department of internal medicine F´laboratory, Gentofte Hospital

Hellerup, Copenhagen, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 23704713 (View on PubMed)

Other Identifiers

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Truncated isoglycemia

Identifier Type: -

Identifier Source: org_study_id