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Severe Insulin Resistance in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Aarhus University Hospital
Regionshospitalet Silkeborg
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00654056
First received: March 25, 2008
Last updated: March 8, 2013
Last verified: March 2013

March 25, 2008
March 8, 2013
March 2008
October 2009   (final data collection date for primary outcome measure)
Insulin sensitivity [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00654056 on ClinicalTrials.gov Archive Site
Changes in insulin signaling proteins? [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Severe Insulin Resistance in Patients With Type 2 Diabetes
Severe Insulin Resistance in Patients With Type 2 Diabetes: Mechanisms Behind Insulin Resistance.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus
Drug: Actrapid (human insulin)
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
  • Experimental: L1
    Actrapid infusion, 0.5 mU/kg/min.
    Intervention: Drug: Actrapid (human insulin)
  • Experimental: L2
    Actrapid infusion 1.5 mU/kg/min
    Intervention: Drug: Actrapid (human insulin)
  • Experimental: H1
    Actrapid infusion 3.0 mU/kg/min
    Intervention: Drug: Actrapid (human insulin)
  • Experimental: H2
    Actrapid infusion 5.0 mU/kg/min
    Intervention: Drug: Actrapid (human insulin)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
October 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe diseases
Both
25 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00654056
UKO-M20070267
No
University of Aarhus
University of Aarhus
  • Aarhus University Hospital
  • Regionshospitalet Silkeborg
Principal Investigator: Niels Moeller, Professor Department M (Endocrinology and diabetes), Aarhus University Hospital, Nørrebrogade 44, 8000 Århus C, Denmark
University of Aarhus
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP