Severe Insulin Resistance in Patients With Type 2 Diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Actrapid (human insulin)

• Registration Number: NCT00654056
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-25
• Study First Submitted QC: 2008-04-02
• Study First Posted: 2008-04-07
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-08
• Last Update Posted: 2013-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

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

Exclusion Criteria

• Severe diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
L1	Actrapid (human insulin)	Actrapid infusion, 0.5 mU/kg/min.
L2	Actrapid (human insulin)	Actrapid infusion 1.5 mU/kg/min
H1	Actrapid (human insulin)	Actrapid infusion 3.0 mU/kg/min
H2	Actrapid (human insulin)	Actrapid infusion 5.0 mU/kg/min

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity	8 hours

Secondary Outcome Measures

Name	Time	Method
Changes in insulin signaling proteins?	1 month