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

December 6, 2012 updated by: Jonatan I Bagger, University Hospital, Gentofte, Copenhagen

The Significance of Intact Vagal Innervation for the GLP-1 Induced Inhibition of Gastric Emptying, Appetite and Food Intake

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen
      • Hellerup, Copenhagen, Denmark, 2900
        • Department of Internal Medicine F' laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vago
Truncally vagotomized subjects (due to duodenal ulcer operation)
Drug: 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

Other Names:
  • Panodil
Other: 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

Other Names:
  • Panodil
Experimental: Cardia
truncally vagotomized subjects (due to esophagus resection)
Drug: 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

Other Names:
  • Panodil
Other: 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

Other Names:
  • Panodil
Experimental: Healthy controls
Healthy control subjects
Drug: 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

Other Names:
  • Panodil
Other: 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

Other Names:
  • Panodil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric emptying
Time Frame: four hours
Gastric emptying will be assessed using a liquid meal with 1.5 g paracetamol added and continuous blood sampling for measuring paracetamol concentration during four hours
four hours
Appetite
Time Frame: four hours
Hunger, satiation, and fullness will be assessed before, during and after a liquid meal with 1.5 g paracetamol added using a visual analog scale (VAS)
four hours
Food intake
Time Frame: five hours
After the liquid meal test, the volunteers will be offered a meal to assessed their ad libitum food intake
five hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
plasma glucose
Time Frame: four hours
four hours
serum insulin and c-peptide
Time Frame: four hours
four hours
plasma glucagon
Time Frame: four hours
four hours
plasma GLP-1
Time Frame: four hours
four hours
endogenous GLP-1
Time Frame: four hours
endogenous GLP-1 will be assessed as plasma GLP-2 concentration
four hours
plasma GIP
Time Frame: four hours
four hours
serum paracetamol
Time Frame: four hours
four hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Collaborators

University of Copenhagen

Investigators

  • Principal Investigator: Astrid Plamboeck, M.D., University Hospital, Gentofte, Copenhagen
  • Study Director: Tina Vilsbøll, M.D., University Hospital, Gentofte, Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

August 1, 2011

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

August 5, 2010

First Submitted That Met QC Criteria

August 5, 2010

First Posted (Estimate)

August 6, 2010

Study Record Updates

Last Update Posted (Estimate)

December 7, 2012

Last Update Submitted That Met QC Criteria

December 6, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Truncated mealtest (AP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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