Back to resultsPharmacological Intervention in Insulin Resistance Targeting Autonomic Nerve Activity
Primary Purpose
Insulin Resistance
Status
Completed
Phase
Early Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Atropine
Physostigmine
Placebo Sodium
Sponsored by
About this trial
This is an interventional basic science trial for Insulin Resistance focused on measuring Clamp
Eligibility 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
Sites / Locations
- Research Site
Outcomes
Primary Outcome Measures
Study the effect of anticholinergic drugs on insulin sensitivity by assessment of glucose infusion rate during hyperinsulinemic euglycemic clamp.
Secondary Outcome Measures
Study the effect of cholinergic stimulation on insulin sensitivity by assessment ofglucose infusion rate during hyperinsulinemic euglycemic clamp.
Study the possible difference in effect of cholinergic (physostigmine) andanticholinergic (atropine) drugs on insulin sensitivity in a lean and abdominal obese subgroup of subjects.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00689208
Brief Title
Pharmacological Intervention in Insulin Resistance Targeting Autonomic Nerve Activity
Official Title
Pharmacological Intervention in Insulin Resistance Targeting Autonomic Nerve Activity - a Concept Study in Mani
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
Clamp
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Atropine
Intervention Description
10 ug/kg bolus, 4 ug/kg/h infusion
Intervention Type
Drug
Intervention Name(s)
Physostigmine
Intervention Description
0,12ug/kg/min
Intervention Type
Drug
Intervention Name(s)
Placebo Sodium
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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).
Title
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per-Anders Jansson, prof
Organizational Affiliation
Lundberg Laboratory for diabetic research, Sahlgrenska Universitetssjukhuset Göteborg, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan Eriksson, MSD
Organizational Affiliation
Clinical Cardiovascular gastrointestinal departmentAstraZeneca R&D Mölnda Swedenl
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Göteborg
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Pharmacological Intervention in Insulin Resistance Targeting Autonomic Nerve Activity
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