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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

May 30, 2008
March 12, 2009
May 2007
October 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00689208 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Pharmacological Intervention in Insulin Resistance Targeting Autonomic Nerve Activity
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.
Not Provided
Interventional
Phase 0
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Insulin Resistance
  • Drug: Atropine
    10 ug/kg bolus, 4 ug/kg/h infusion
  • Drug: Physostigmine
    0,12ug/kg/min
  • Drug: Placebo Sodium
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
November 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00689208
D4411M00007
No
Björn Carlsson, MD, PhD, Medical Science Discovery Medicine CDT, AstraZeneca R&D Mölndal, Sweden
AstraZeneca
Not Provided
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
AstraZeneca
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP