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Pharmacological Intervention in Insulin Resistance Targeting Autonomic Nerve Activity

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00689208
First received: May 30, 2008
Last updated: March 12, 2009
Last verified: January 2009
History of Changes
  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
 Phase 0

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

Resource links provided by NLM:

U.S. FDA Resources

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). ] [ Designated as safety issue: No ]

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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 30, 2008
Last Updated: March 12, 2009
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:
Clamp

Additional relevant MeSH terms:
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Atropine
Physostigmine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular 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
Cholinesterase Inhibitors
Enzyme Inhibitors
Miotics

ClinicalTrials.gov processed this record on May 16, 2013