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Severe Insulin Resistance in Patients With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Actrapid (human insulin)
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring Type 2 diabetes, Severe insulin resistance

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    L1

    L2

    H1

    H2

    Arm Description

    Actrapid infusion, 0.5 mU/kg/min.

    Actrapid infusion 1.5 mU/kg/min

    Actrapid infusion 3.0 mU/kg/min

    Actrapid infusion 5.0 mU/kg/min

    Outcomes

    Primary Outcome Measures

    Insulin sensitivity

    Secondary Outcome Measures

    Changes in insulin signaling proteins?

    Full Information

    First Posted
    March 25, 2008
    Last Updated
    March 8, 2013
    Sponsor
    University of Aarhus
    Collaborators
    Aarhus University Hospital, Regionshospitalet Silkeborg
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00654056
    Brief Title
    Severe Insulin Resistance in Patients With Type 2 Diabetes
    Official Title
    Severe Insulin Resistance in Patients With Type 2 Diabetes: Mechanisms Behind Insulin Resistance.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2008 (undefined)
    Primary Completion Date
    October 2009 (Actual)
    Study Completion Date
    October 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Aarhus
    Collaborators
    Aarhus University Hospital, Regionshospitalet Silkeborg

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Mellitus
    Keywords
    Type 2 diabetes, Severe insulin resistance

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    8 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    L1
    Arm Type
    Experimental
    Arm Description
    Actrapid infusion, 0.5 mU/kg/min.
    Arm Title
    L2
    Arm Type
    Experimental
    Arm Description
    Actrapid infusion 1.5 mU/kg/min
    Arm Title
    H1
    Arm Type
    Experimental
    Arm Description
    Actrapid infusion 3.0 mU/kg/min
    Arm Title
    H2
    Arm Type
    Experimental
    Arm Description
    Actrapid infusion 5.0 mU/kg/min
    Intervention Type
    Drug
    Intervention Name(s)
    Actrapid (human insulin)
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Insulin sensitivity
    Time Frame
    8 hours
    Secondary Outcome Measure Information:
    Title
    Changes in insulin signaling proteins?
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 25-75 years old BMI between 25 and 42 Exclusion Criteria: Severe diseases
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Niels Moeller, Professor
    Organizational Affiliation
    Department M (Endocrinology and diabetes), Aarhus University Hospital, Nørrebrogade 44, 8000 Århus C, Denmark
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Severe Insulin Resistance in Patients With Type 2 Diabetes

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