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

The recruitment status of this study is unknown because the information has not been verified recently.

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

Sponsor:

Collaborator:

University of Copenhagen

Information provided by (Responsible Party):

Jonatan I Bagger, University Hospital, Gentofte, Copenhagen

ClinicalTrials.gov Identifier:

NCT01176890

First received: August 5, 2010

Last updated: December 6, 2012

Last verified: December 2012

History of Changes

Purpose

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	Intervention
Vagotomy, Truncal	Drug: GLP-1 Other: Saline


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: 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

Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:

Gastric emptying [ Time Frame: four hours ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
serum insulin and c-peptide [ Time Frame: four hours ] [ Designated as safety issue: No ]
plasma glucagon [ Time Frame: four hours ] [ Designated as safety issue: No ]
plasma GLP-1 [ Time Frame: four hours ] [ Designated as safety issue: No ]
endogenous GLP-1 [ Time Frame: four hours ] [ Designated as safety issue: No ]
endogenous GLP-1 will be assessed as plasma GLP-2 concentration
plasma GIP [ Time Frame: four hours ] [ Designated as safety issue: No ]
serum paracetamol [ Time Frame: four hours ] [ Designated as safety issue: No ]


Estimated Enrollment:	30
Study Start Date:	July 2008
Estimated Study Completion Date:	December 2012
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01176890

Locations


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

Sponsors and Collaborators

University Hospital, Gentofte, Copenhagen

University of Copenhagen

Investigators


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

More Information

No publications provided by University Hospital, Gentofte, Copenhagen

Additional 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.


Responsible Party:	Jonatan I Bagger, MD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:	NCT01176890 History of Changes
Other Study ID Numbers:	Truncated mealtest (AP)
Study First Received:	August 5, 2010
Last Updated:	December 6, 2012
Health Authority:	Denmark: Danish Dataprotection Agency

Keywords provided by University Hospital, Gentofte, Copenhagen:


truncal vagotomy GLP-1 gastric emptying appetite food intake

ClinicalTrials.gov processed this record on March 03, 2015

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