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Pharmacological Intervention in Insulin Resistance Targeting Autonomic Nerve Activity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00689208
First Posted: June 3, 2008
Last Update Posted: March 13, 2009
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.
Information provided by:
AstraZeneca
  Purpose
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.

Condition Intervention Phase
Insulin Resistance Drug: Atropine Drug: Physostigmine Drug: Placebo Sodium Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Pharmacological Intervention in Insulin Resistance Targeting Autonomic Nerve Activity - a Concept Study in Mani

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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). ]

Secondary Outcome Measures:
  • 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). ]
  • 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). ]

Estimated Enrollment: 12
Study Start Date: May 2007
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Atropine
    10 ug/kg bolus, 4 ug/kg/h infusion
    Drug: Physostigmine
    0,12ug/kg/min
    Drug: Placebo Sodium
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  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): NCT00689208


Locations
Sweden
Research Site
Göteborg, Sweden
Sponsors and Collaborators
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
  More Information

Responsible Party: Björn Carlsson, MD, PhD, Medical Science Discovery Medicine CDT, AstraZeneca R&D Mölndal, Sweden
ClinicalTrials.gov Identifier: NCT00689208     History of Changes
Other Study ID Numbers: D4411M00007
First Submitted: May 30, 2008
First Posted: June 3, 2008
Last Update Posted: March 13, 2009
Last Verified: January 2009

Keywords provided by AstraZeneca:
Clamp

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Atropine
Physostigmine
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinesterase Inhibitors
Enzyme Inhibitors
Miotics