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

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ClinicalTrials.gov Identifier: NCT01176760
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

Brief Summary:

The aim of this study is to investigate the role of transmission via the vagal nerve for the effect of glucose and Glucagon-like peptide-1 (GLP-1) in respect to insulin secretion.

The hypothesis is that a great deal of the effects of GLP-1 is mediated via the nervous system and for this reason the investigators will research individuals with and without intact nervous supply.


Condition or disease Intervention/treatment Phase
Vagotomy, Truncal Drug: Dipeptidyl peptidase 4 (DPP 4) inhibitor Other: oral glucose 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 glucose and GLP-1 on the insulin secretion

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 Significances of Intact Vagal Innervation for the Glucose and GLP1 Induced Insulin Secretion
Study Start Date : August 2009
Actual Primary Completion Date : October 2011
Estimated Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: Vago
Truncally vagotomized subjects (due to duodenal ulcer operation)
Drug: Dipeptidyl peptidase 4 (DPP 4) inhibitor
One tablet (50 mg)of DPP4 inhibitor is to be taken 12 and 1 hours before start of the oral glucose tolerance test (50 g glucose and 1.5 g paracetamol dissolved in 300 ml water)on day 3
Other Name: Galvus
Other: oral glucose
50 g glucose dissolved in 300 ml water with 1,5 g paracetamol is to be ingested orally within the first 15 minutes.
Other Name: panodil
Experimental: Cardia
Truncally vagotomized subjects (due to cardia resection)
Drug: Dipeptidyl peptidase 4 (DPP 4) inhibitor
One tablet (50 mg)of DPP4 inhibitor is to be taken 12 and 1 hours before start of the oral glucose tolerance test (50 g glucose and 1.5 g paracetamol dissolved in 300 ml water)on day 3
Other Name: Galvus
Other: oral glucose
50 g glucose dissolved in 300 ml water with 1,5 g paracetamol is to be ingested orally within the first 15 minutes.
Other Name: panodil
Experimental: Ctrl
Healthy matched control subjects
Drug: Dipeptidyl peptidase 4 (DPP 4) inhibitor
One tablet (50 mg)of DPP4 inhibitor is to be taken 12 and 1 hours before start of the oral glucose tolerance test (50 g glucose and 1.5 g paracetamol dissolved in 300 ml water)on day 3
Other Name: Galvus
Other: oral glucose
50 g glucose dissolved in 300 ml water with 1,5 g paracetamol is to be ingested orally within the first 15 minutes.
Other Name: panodil



Primary Outcome Measures :
  1. insulin secretion [ Time Frame: four hours ]
    The insulin secretion during a four-hour oral glucose tolerance test (OGTT) and an intravenous isoglycaemic clamp is evaluated


Secondary Outcome Measures :
  1. plasma GLP-1 [ Time Frame: 12 time points within four hours ]
    12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour

  2. plasma GIP [ Time Frame: 12 time points within four hours ]
    12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour

  3. plasma glucagon [ Time Frame: 12 time points within four hours ]
    12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour

  4. plasma GLP-2 [ Time Frame: 12 time points within four hours ]
    12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour

  5. plasma PYY [ Time Frame: 12 time points within four hours ]
    12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • normal fasting plasma glucose
  • normal hemoglobin
  • informed consent

Exclusion Criteria:

  • type 1 diabetes mellitus or type 2 diabetes mellitus
  • body mass index > 30
  • inflammatory bowel disease
  • intestinal surgery
  • serum creatinine > 250 µM and/or albuminuria
  • ALAT > 2 x normal value
  • Severe cardiac insufficiency
  • in treatment with medicine which cannot be paused for 12 hours

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): NCT01176760


Locations
Denmark
Department of internal medicine F´laboratory, Gentofte Hospital
Hellerup, Copenhagen, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
University of Copenhagen
Investigators
Principal Investigator: Astrid Plamboeck, MD University Hospital, Gentofte, Copenhagen
Study Director: Tina Vilsbøll, MD, dr.med University Hospital, Gentofte, Copenhagen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jonatan I Bagger, MD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01176760     History of Changes
Other Study ID Numbers: Truncated isoglycemia
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:
vagotomy
vagus
GLP-1
Insulin secretion

Additional relevant MeSH terms:
Glucagon-Like Peptide 1
Dipeptidyl-Peptidase IV Inhibitors
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents