Text Size

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

This study is ongoing, but not recruiting participants.
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

Resource links provided by NLM:

Drug Information available for: Glucagon
U.S. FDA Resources

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
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

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

Additional relevant MeSH terms:
Glucagon-Like Peptide 1
Glucagon
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013