Severe Insulin Resistance in Patients With Type 2 Diabetes
March 8, 2013 updated by: University of Aarhus
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 25-75 years old
- BMI between 25 and 42
Exclusion Criteria:
- Severe diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: L1
Actrapid infusion, 0.5 mU/kg/min.
|
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: L2
Actrapid infusion 1.5 mU/kg/min
|
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: H1
Actrapid infusion 3.0 mU/kg/min
|
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: H2
Actrapid infusion 5.0 mU/kg/min
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Insulin sensitivity
Time Frame: 8 hours
|
8 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in insulin signaling proteins?
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
March 25, 2008
First Submitted That Met QC Criteria
April 2, 2008
First Posted (Estimate)
April 7, 2008
Study Record Updates
Last Update Posted (Estimate)
March 11, 2013
Last Update Submitted That Met QC Criteria
March 8, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UKO-M20070267
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.