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

NCT ID: NCT01176890

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

2008-07-31

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 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.

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 GLP-1 on the food intake, gastric emptying (GE) and appetite.

Conditions

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Vagotomy, Truncal

Keywords

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truncal vagotomy GLP-1 gastric emptying appetite food intake

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

GLP-1

Intervention Type DRUG

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

Saline

Intervention Type OTHER

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

Cardia

truncally vagotomized subjects (due to esophagus resection)

Group Type EXPERIMENTAL

GLP-1

Intervention Type DRUG

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

Saline

Intervention Type OTHER

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

Healthy controls

Healthy control subjects

Group Type EXPERIMENTAL

GLP-1

Intervention Type DRUG

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

Saline

Intervention Type OTHER

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

Interventions

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GLP-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

Intervention Type DRUG

Saline

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

Intervention Type OTHER

Other Intervention Names

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Panodil Panodil

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

18 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, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Gentofte, Copenhagen

Tina Vilsbøll, M.D.

Role: STUDY_DIRECTOR

University Hospital, Gentofte, Copenhagen

Locations

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Department of Internal Medicine F' laboratory

Hellerup, Copenhagen, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 24891019 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23599045 (View on PubMed)

Other Identifiers

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Truncated mealtest (AP)

Identifier Type: -

Identifier Source: org_study_id