Severe Insulin Resistance in Patients With Type 2 Diabetes

University of Aarhus

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Actrapid (human insulin)

Study type: Interventional

Funder types: Other

Identifiers

NCT00654056

UKO-M20070267

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Severe diseases

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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8 participants in 4 patient groups

L1

Experimental group

Description:

Actrapid infusion, 0.5 mU/kg/min.

Treatment:

Drug: Actrapid (human insulin)

L2

Experimental group

Description:

Actrapid infusion 1.5 mU/kg/min

Treatment:

Drug: Actrapid (human insulin)

H1

Experimental group

Description:

Actrapid infusion 3.0 mU/kg/min

Treatment:

Drug: Actrapid (human insulin)

H2

Experimental group

Description:

Actrapid infusion 5.0 mU/kg/min

Treatment:

Drug: Actrapid (human insulin)