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

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ClinicalTrials.gov Identifier: NCT01176890

Recruitment Status : Unknown

Verified December 2012 by Jonatan I Bagger, University Hospital, Gentofte, Copenhagen.
Recruitment status was: Active, not recruiting

First Posted : August 6, 2010

Last Update Posted : December 7, 2012

Sponsor:

Collaborator:

University of Copenhagen

Information provided by (Responsible Party):

Jonatan I Bagger, University Hospital, Gentofte, Copenhagen

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Vagotomy, Truncal	Drug: GLP-1 Other: Saline	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	30 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Basic Science
Official Title:	The Significance of Intact Vagal Innervation for the GLP-1 Induced Inhibition of Gastric Emptying, Appetite and Food Intake
Study Start Date :	July 2008
Actual Primary Completion Date :	August 2011
Estimated Study Completion Date :	December 2012

Arms and Interventions

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Panodil

Outcome Measures

Primary Outcome Measures :

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
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)
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

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01176890

Locations

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

Sponsors and Collaborators

University Hospital, Gentofte, Copenhagen

University of Copenhagen

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wewer Albrechtsen NJ, Hartmann B, Veedfald S, Windeløv JA, Plamboeck A, Bojsen-Møller KN, Idorn T, Feldt-Rasmussen B, Knop FK, Vilsbøll 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.

Plamboeck A, Veedfald S, Deacon CF, Hartmann B, Wettergren A, Svendsen LB, Meisner S, Hovendal C, Vilsbøll 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.

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Responsible Party:	Jonatan I Bagger, MD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:	NCT01176890
Other Study ID Numbers:	Truncated mealtest (AP)
First Posted:	August 6, 2010 Key Record Dates
Last Update Posted:	December 7, 2012
Last Verified:	December 2012

Keywords provided by Jonatan I Bagger, University Hospital, Gentofte, Copenhagen:


truncal vagotomy GLP-1 gastric emptying appetite food intake

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