Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 5, 2010
First Posted Date  ICMJE August 6, 2010
Last Update Posted Date December 7, 2012
Study Start Date  ICMJE July 2008
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2010)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intact Vagal Innervation and Glucagon-like Peptide-1 (GLP-1) Effects
Official Title  ICMJE The Significance of Intact Vagal Innervation for the GLP-1 Induced Inhibition of Gastric Emptying, Appetite and Food Intake
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Vagotomy, Truncal
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Vago
    Truncally vagotomized subjects (due to duodenal ulcer operation)
    Interventions:
    • Drug: GLP-1
    • Other: Saline
  • Experimental: Cardia
    truncally vagotomized subjects (due to esophagus resection)
    Interventions:
    • Drug: GLP-1
    • Other: Saline
  • Experimental: Healthy controls
    Healthy control subjects
    Interventions:
    • Drug: GLP-1
    • Other: Saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 5, 2010)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01176890
Other Study ID Numbers  ICMJE Truncated mealtest (AP)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonatan I Bagger, University Hospital, Gentofte, Copenhagen
Study Sponsor  ICMJE University Hospital, Gentofte, Copenhagen
Collaborators  ICMJE University of Copenhagen
Investigators  ICMJE
Principal Investigator: Astrid Plamboeck, M.D. University Hospital, Gentofte, Copenhagen
Study Director: Tina Vilsbøll, M.D. University Hospital, Gentofte, Copenhagen
PRS Account University Hospital, Gentofte, Copenhagen
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP