Pharmacological Intervention in Insulin Resistance Targeting Autonomic Nerve Activity

March 12, 2009 updated by: AstraZeneca

Pharmacological Intervention in Insulin Resistance Targeting Autonomic Nerve Activity - a Concept Study in Mani

The present study on pharmacological intervention in autonomic nervous dysregulation(parasympathetic dysfunction,) regarding insulin resistance, is a concept testing in humans tohelp identify potential new pharmacological target sites in the central nervous system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Early Phase 1

Contacts and Locations

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

Study Locations

  • Sweden
      • Göteborg, Sweden
        • Research Site

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed written informed consent
  • BMI of lean and abdominally obese men and women
  • weight stable

Exclusion Criteria:

  • Ongoing clinically significant diseases
  • History of repeated syncope
  • resting pulse<50 or systolic blood pressure <100

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: Crossover Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Study the effect of anticholinergic drugs on insulin sensitivity by assessment of glucose infusion rate during hyperinsulinemic euglycemic clamp.
Time Frame: After Insulin bolus, following will be measured; p-glucose (every 5 minutes), blood samples (every 30 minutes), pulse (every 5 minutes the first hour then every 10 minutes), blood pressure will be measured (the same as pulse).
After Insulin bolus, following will be measured; p-glucose (every 5 minutes), blood samples (every 30 minutes), pulse (every 5 minutes the first hour then every 10 minutes), blood pressure will be measured (the same as pulse).

Secondary Outcome Measures

Outcome Measure
Time Frame
Study the effect of cholinergic stimulation on insulin sensitivity by assessment ofglucose infusion rate during hyperinsulinemic euglycemic clamp.
Time Frame: measured; p-glucose (every 5 minutes), blood samples (every 30 minutes), pulse (every 5 minutes the first hour then every 10 minutes), blood pressure will be measured (the same as pulse).
measured; p-glucose (every 5 minutes), blood samples (every 30 minutes), pulse (every 5 minutes the first hour then every 10 minutes), blood pressure will be measured (the same as pulse).
Study the possible difference in effect of cholinergic (physostigmine) andanticholinergic (atropine) drugs on insulin sensitivity in a lean and abdominal obese subgroup of subjects.
Time Frame: measured; p-glucose (every 5 minutes), blood samples (every 30 minutes), pulse (every 5 minutes the first hour then every 10 minutes), blood pressure will be measured (the same as pulse).
measured; p-glucose (every 5 minutes), blood samples (every 30 minutes), pulse (every 5 minutes the first hour then every 10 minutes), blood pressure will be measured (the same as pulse).

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Per-Anders Jansson, prof, Lundberg Laboratory for diabetic research, Sahlgrenska Universitetssjukhuset Göteborg, Sweden
  • Study Chair: Jan Eriksson, MSD, Clinical Cardiovascular gastrointestinal departmentAstraZeneca R&D Mölnda Swedenl

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

May 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

May 30, 2008

First Submitted That Met QC Criteria

May 30, 2008

First Posted (Estimate)

June 3, 2008

Study Record Updates

Last Update Posted (Estimate)

March 13, 2009

Last Update Submitted That Met QC Criteria

March 12, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4411M00007

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.

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