Pharmacological Intervention in Insulin Resistance Targeting Autonomic Nerve Activity

NCT00689208 | Completed Early Phase 1

• 1 other identifier: D4411M00007
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance

Keywords

Clamp

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (2)

• 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).

• 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).

Interventions

Atropine DRUG

10 ug/kg bolus, 4 ug/kg/h infusion

Physostigmine DRUG

0,12ug/kg/min

Placebo Sodium DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed written informed consent
• BMI of lean and abdominally obese men and women
• weight stable

You may not qualify if:

• Ongoing clinically significant diseases
• History of repeated syncope
• resting pulse\<50 or systolic blood pressure \<100

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Atropine; Physostigmine

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Per-Anders Jansson, prof

  Lundberg Laboratory for diabetic research, Sahlgrenska Universitetssjukhuset Göteborg, Sweden

  PRINCIPAL INVESTIGATOR

• Jan Eriksson, MSD

  Clinical Cardiovascular gastrointestinal departmentAstraZeneca R&D Mölnda Swedenl

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 30, 2008
• First Posted: June 3, 2008
• Study Start: May 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: November 1, 2008
• Last Updated: March 13, 2009

Record last verified: 2009-01

Locations

SE (1)