|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
University of Aarhus Aarhus University Hospital Silkeborg Hospital, Denmark |
|---|---|
| Information provided by: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT00654056 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Actrapid (human insulin) |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Single Blind (Subject), Crossover Assignment, Pharmacodynamics Study |
| Official Title: | Severe Insulin Resistance in Patients With Type 2 Diabetes: Mechanisms Behind Insulin Resistance. |
| Estimated Enrollment: | 8 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | May 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Hyperinsulinemic euglycemic clamp at 4 different insulin doses.
|
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
|
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.
Eligibility| Ages Eligible for Study: | 25 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Principal Investigator: | Niels Moeller, Professor | Department M (Endocrinology and diabetes), Aarhus University Hospital, Nørrebrogade 44, 8000 Århus C, Denmark |
More Information
| Responsible Party: | Department of Endocrinology M, Aarhus University Hospital ( Professor, MD, Niels Moeller ) |
| Study ID Numbers: | UKO-M20070267 |
| Study First Received: | March 25, 2008 |
| Last Updated: | April 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00654056 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics; Denmark: The Regional Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency |
|
Type 2 diabetes Severe insulin resistance |
|
Hyperinsulinism Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Insulin Resistance Metabolic disorder Glucose Metabolism Disorders Insulin |
|
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
