Atropin and Glucose Stimulated Insulinsecretion and the Cephalic Insulin Response

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University Hospital, Gentofte, Copenhagen
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Jonatan I Bagger, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01534442
First received: February 13, 2012
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

The aim of this study is to investigate the role of transmission of vagal cholinerg for the GLP-1 potentiation of the glucose stimulated insulin secretion and the cephalic insulin response by using atropin administration.

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 an intact nervous supply with and without atropin administration.


Condition Intervention
The Focus of This Study is to Evaluete the Significances of the Vagal Cholinerg Nervuos System for the Effect of GLP-1 by Using Atropin Administration.
Drug: Atropine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: The Significances of Atropin Administration for the GLP-1 Potentiation of Glucose Induced Insulin Secretion and the Cephalic Insulin Response

Resource links provided by NLM:


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

Primary Outcome Measures:
  • insulin secretion [ Time Frame: tree hours ] [ Designated as safety issue: No ]
    The insulin secretion during lightly elevated blood glucose during GLP-1 infusions with and without atropin administration is evaluated. Also the insulin secretion during lightly elevated blood glucose during a sham-feeding with and without atropin administration is evaluated.


Secondary Outcome Measures:
  • Plasma PP [ Time Frame: 20 time points within tree hours ] [ Designated as safety issue: No ]
    20 blood samlpes will be drawn during lightly elevated blood glucose during a sham-feeding with and without atropin administration.

  • Plasma glucose [ Time Frame: 30 within tree hours ] [ Designated as safety issue: No ]
    30 blood samlpes will be drawn during lightly elevated blood glucose during a sham-feeding with and without atropin administration.

  • Plasma GLP-1 [ Time Frame: 20 time points within tree hours ] [ Designated as safety issue: No ]
    20 blood samlpes will be drawn during lightly elevated blood glucose during a sham-feeding with and without atropin administration.

  • Plasma GLP-1 [ Time Frame: 18 time points within tree hours ] [ Designated as safety issue: No ]
    18 blood samples will be drawn during lightly elevated blood glucose during GLP-1 infusions with and without atropin administration.

  • Plasma GLP-2 [ Time Frame: 18 time points within tree hours ] [ Designated as safety issue: No ]
    18 blood samples will be drawn during lightly elevated blood glucose during GLP-1 infusions with and without atropin administration.

  • Plasma GIP [ Time Frame: 18 timepoints within tree hours ] [ Designated as safety issue: No ]
    18 blood samples will be drawn during lightly elevated blood glucose during GLP-1 infusions with and without atropin administration.

  • Plasma glucagon [ Time Frame: 18 timepoints within tree hours ] [ Designated as safety issue: No ]
    18 blood samples will be drawn during lightly elevated blood glucose during GLP-1 infusions with and without atropin administration.

  • Plasma glucose [ Time Frame: 33 timepoints within tree hours ] [ Designated as safety issue: No ]
    33 blood samples will be drawn during lightly elevated blood glucose during GLP-1 infusions with and without atropin administration.


Estimated Enrollment: 10
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Atropin
Atropin
Drug: Atropine
1 mg as a bolus and the and infusion of 80 ng/kg/min for either 105 or 145 minuts.
Placebo Comparator: Placebo
Saline
Drug: Placebo

Detailed Description:

GLP-1 is a importent enterogastron and incretin hormone. Rapid degradation of GLP-1 by dipeptidyl peptidase 4 (DPP-4) suggests that GLP-1 may act locally (through vagal afferents) before being degraded. We aimed to clarify the role of vagal innervation on the incretin effect.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age between 18 and 45 years
  • normal fasting plasma glucose
  • normal hemoglobin
  • informed consent

Exclusion Criteria:

  • diabetes mellitus
  • body mass index above 30
  • inflamatoric bowel disease
  • intestinal surgery
  • serum creatinine above 250 microM
  • ALAT above to times normal value
  • treatment with medicine wich cannot be paused for 12 hours
  • contraindication for treatment with atropin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534442

Contacts
Contact: Astrid Plamboeck, MD + 45 26208174 astridp@sund.ku.dk

Locations
Denmark
Diabetes research Division, Department of Internal Medicin, Gentofte Hospital Recruiting
Hellerup, Denmark, 2900
Contact: Astrid Plamboeck, MD    +45 26208174    astridp@sund.ku.dk   
Contact: Tina Vilsbøll, MD, Dr. med    +45 40940825    t.vilsboll@dadlnet.dk   
Principal Investigator: Astrid Plamboeck, MD         
Diabetes Research Division, Department of Internal Medicine, Gentofte Hospital, Copenhagen Denmark Recruiting
Hellerup, Denmark, 2900
Contact: Astrid Plamboeck, MD    +45 26208174    astridp@sund.ku.dk   
Principal Investigator: Astrid Plamboeck, MD         
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
University of Copenhagen
Investigators
Study Director: Tina Vilsbøll, MD, Dr. med Diabetes research Division, Department of Internal Medicine, Gentofte Hospital, Copenhagen, Denamrk
  More Information

No publications provided

Responsible Party: Jonatan I Bagger, MD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01534442     History of Changes
Other Study ID Numbers: Atropin clamp
Study First Received: February 13, 2012
Last Updated: December 6, 2012
Health Authority: Denmark: The Danish Dataprotection Agency

ClinicalTrials.gov processed this record on October 22, 2014