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Sponsors and Collaborators: |
University of Texas Southwestern Medical Center Children's Medical Center Foundation |
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Information provided by: | University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT00645840 |
The purpose of this study is to determine whether control of inflammatory pathways mediated by IL-1 beta using the IL-1 receptor antagonist anakinra will yield measurable decreases in expression of genes that are otherwise overexpressed as a consequence of IL-1 beta effects in children with newly diagnosed type 1 diabetes. Ultimately, we believe that control of IL-1 beta pathways will be associated with preserved insulin secretory capacity.
Condition | Intervention | Phase |
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Type 1 Diabetes Mellitus |
Drug: Anakinra |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Historical Control, Single Group Assignment, Efficacy Study |
Official Title: | An Exploratory, Open Label Study of Anti-Inflammatory Therapy With Anakinra in Children With Newly Diagnosed Type 1 Diabetes Mellitus |
Estimated Enrollment: | 15 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 6 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
Children's Medical Center | |
Dallas, Texas, United States, 75235 |
Principal Investigator: | Soumya Adhikari, MD | UT Southwestern Medical Center |
Responsible Party: | UT Southwestern Medical Center ( Soumya Adhikari, MD ) |
Study ID Numbers: | UTSW 112007-037 |
Study First Received: | March 25, 2008 |
Last Updated: | March 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00645840 History of Changes |
Health Authority: | United States: Institutional Review Board |
Type 1 diabetes mellitus IL1 beta Anakinra |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases Diabetes Mellitus Type 1 |
Interleukin 1 Receptor Antagonist Protein Endocrinopathy Antirheumatic Agents Glucose Metabolism Disorders Metabolic Disorder |
Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 Therapeutic Uses Diabetes Mellitus |
Endocrine System Diseases Interleukin 1 Receptor Antagonist Protein Antirheumatic Agents Glucose Metabolism Disorders Pharmacologic Actions |