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Atropin and Glucose Stimulated Insulinsecretion and the Cephalic Insulin Response

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Jonatan I Bagger, University Hospital, Gentofte, Copenhagen.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01534442
First Posted: February 16, 2012
Last Update Posted: December 7, 2012
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.
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Jonatan I Bagger, University Hospital, Gentofte, Copenhagen
  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
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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 Jonatan I Bagger, University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • insulin secretion [ Time Frame: tree hours ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
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): 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

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: NCT01534442     History of Changes
Other Study ID Numbers: Atropin clamp
First Submitted: February 13, 2012
First Posted: February 16, 2012
Last Update Posted: December 7, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Insulin
Atropine
Hypoglycemic Agents
Physiological Effects of Drugs
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action