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
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
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
NCT ID
NCT00654056
First Posted
March 25, 2008
Last Updated
March 8, 2013
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Regionshospitalet Silkeborg
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
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Severe Insulin Resistance in Patients With Type 2 Diabetes
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