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

Vagotomy, Truncal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01176890
• Other study ID #: Truncated mealtest (AP)
• Status: Active, not recruiting
• Phase: N/A
• First received: August 5, 2010
• Last updated: December 6, 2012
• Start date: July 2008
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Vagotomy, Truncal

Intervention

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:
• 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

Locations

Country	Name	City	State
Denmark	Department of Internal Medicine F' laboratory	Hellerup	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric emptying	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	No
Primary	Appetite	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	No
Primary	Food intake	After the liquid meal test, the volunteers will be offered a meal to assessed their ad libitum food intake	five hours	No
Secondary	plasma glucose		four hours	No
Secondary	serum insulin and c-peptide		four hours	No
Secondary	plasma glucagon		four hours	No
Secondary	plasma GLP-1		four hours	No
Secondary	endogenous GLP-1	endogenous GLP-1 will be assessed as plasma GLP-2 concentration	four hours	No
Secondary	plasma GIP		four hours	No
Secondary	serum paracetamol		four hours	No