Atropin and Glucose Stimulated Insulinsecretion and the Cephalic Insulin Response

December 6, 2012 updated by: Jonatan I Bagger, University Hospital, Gentofte, Copenhagen

The Significances of Atropin Administration for the GLP-1 Potentiation of Glucose Induced Insulin Secretion and the Cephalic Insulin Response

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Hellerup, Denmark, 2900
        • Recruiting
        • Diabetes research Division, Department of Internal Medicin, Gentofte Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Astrid Plamboeck, MD
      • Hellerup, Denmark, 2900
        • Recruiting
        • Diabetes Research Division, Department of Internal Medicine, Gentofte Hospital, Copenhagen Denmark
        • Contact:
        • Principal Investigator:
          • Astrid Plamboeck, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Saline
Drug: Placebo
Active Comparator: Atropin
Drug: Atropine
1 mg as a bolus and the and infusion of 80 ng/kg/min for either 105 or 145 minuts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
tree hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
20 time points within tree hours
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.
30 within tree hours
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.
20 time points within tree hours
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.
18 time points within tree hours
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.
18 time points within tree hours
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.
18 timepoints within tree hours
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.
18 timepoints within tree hours
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.
33 timepoints within tree hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Collaborators

University of Copenhagen

Investigators

  • Study Director: Tina Vilsbøll, MD, Dr. med, Diabetes research Division, Department of Internal Medicine, Gentofte Hospital, Copenhagen, Denamrk

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

February 13, 2012

First Submitted That Met QC Criteria

February 15, 2012

First Posted (Estimate)

February 16, 2012

Study Record Updates

Last Update Posted (Estimate)

December 7, 2012

Last Update Submitted That Met QC Criteria

December 6, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Atropin clamp

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on 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.

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