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Severe Insulin Resistance in Patients With Type 2 Diabetes

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00654056
Enrollment
8
Registered
2008-04-07
Start date
2008-03-31
Completion date
2009-10-31
Last updated
2013-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes, Severe insulin resistance

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.

Interventions

On day one: 0,5 IU/kg/min for 3 hours, 1,5 IU/kg/min for 3 hours, on day two: 3,0 IU/kg/min for 3 hours, 5,0 IU/kg/min for 3 hours

Sponsors

Aarhus University Hospital
CollaboratorOTHER
Regionshospitalet Silkeborg
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Severe diseases

Design outcomes

Primary

MeasureTime frame
Insulin sensitivity8 hours

Secondary

MeasureTime frame
Changes in insulin signaling proteins?1 month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026