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NCT Number: NCT00689208

Pharmacological Intervention in Insulin Resistance Targeting Autonomic Nerve Activity

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.

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Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Research Site

Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atropine

Drug

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

Physostigmine

Drug

0,12ug/kg/min

Placebo Sodium

Drug

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 3, 2008
Registry last updated
Mar 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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