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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Insulin Resistance
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Physostigmine
Autonomic Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Miotics
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014