Pharmacological Intervention in Insulin Resistance Targeting Autonomic Nerve Activity

Insulin Resistance Clinical Trial

Official title:

Pharmacological Intervention in Insulin Resistance Targeting Autonomic Nerve Activity - a Concept Study in Mani

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689208
• Other study ID #: D4411M00007
• Status: Completed
• Phase: Phase 0
• First received: May 30, 2008
• Last updated: March 12, 2009
• Start date: May 2007
• Est. completion date: November 2008

Study information

• Verified date: January 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Drug:
• Atropine
10 ug/kg bolus, 4 ug/kg/h infusion
• Physostigmine
0,12ug/kg/min
• Placebo Sodium

Locations

Country	Name	City	State
Sweden	Research Site	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study the effect of anticholinergic drugs on insulin sensitivity by assessment of glucose infusion rate during hyperinsulinemic euglycemic clamp.		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).	No
Secondary	Study the effect of cholinergic stimulation on insulin sensitivity by assessment ofglucose infusion rate during hyperinsulinemic euglycemic clamp.		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).	No
Secondary	Study the possible difference in effect of cholinergic (physostigmine) andanticholinergic (atropine) drugs on insulin sensitivity in a lean and abdominal obese subgroup of subjects.		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).	Yes