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Clinical Trials/NCT00654056
NCT00654056
Completed
Not Applicable

Severe Insulin Resistance in Patients With Type 2 Diabetes: Mechanisms Behind Insulin Resistance.

University of Aarhus0 sites8 target enrollmentMarch 2008

Overview

Phase
Not Applicable
Intervention
Actrapid (human insulin)
Conditions
Type 2 Diabetes Mellitus
Sponsor
University of Aarhus
Enrollment
8
Primary Endpoint
Insulin sensitivity
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

The purpose of the study is to investigate some of the mechanisms behind severe insulin resistance and to determine the dose response to insulin in patients with type 2 diabetes mellitus.

Detailed Description

Overnutrition and obesity are pivotal to the metabolic syndrome and diabetes. The sedentary lifestyle and overly rich nutrition are predominant in Western societies and result in obesity, insulin resistance and type 2 diabetes mellitus. According to the WHO an escalating global epidemic of overweight and obesity is sweeping the globe and the prevalence of type 2 diabetes mellitus rises in parallel at the same alarming rate. It is likely that inherited insulin resistance relates to subtle mutations in many metabolic genes. It is still unclear whether such abnormalities lead to different proteomic patterns in target tissues (muscle and fat) and how intracellular hormone signaling is affected. Some patients with type 2 diabetes mellitus have severe insulin resistance with insulin requirements of more than 100 units/day and are still not optimally controlled. Our aim of this study is to examine the mechanisms behind severe insulin resistance and to elucidate how intracellular hormone signaling is affected, especially in relation to proteomics. Moreover we wish to determine the dose response to insulin in patients with type 2 diabetes mellitus with severe insulin resistance in order to see if there is a measurable effect on blood glucose at high insulin doses.

Registry
clinicaltrials.gov
Start Date
March 2008
End Date
October 2009
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 25-75 years old
  • BMI between 25 and 42

Exclusion Criteria

  • Severe diseases

Arms & Interventions

L1

Actrapid infusion, 0.5 mU/kg/min.

Intervention: Actrapid (human insulin)

L2

Actrapid infusion 1.5 mU/kg/min

Intervention: Actrapid (human insulin)

H1

Actrapid infusion 3.0 mU/kg/min

Intervention: Actrapid (human insulin)

H2

Actrapid infusion 5.0 mU/kg/min

Intervention: Actrapid (human insulin)

Outcomes

Primary Outcomes

Insulin sensitivity

Time Frame: 8 hours

Secondary Outcomes

  • Changes in insulin signaling proteins?(1 month)

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