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| Sponsor: | University of Texas Southwestern Medical Center |
|---|---|
| Collaborator: |
Children's Medical Center Dallas |
| Information provided by: | University of Texas Southwestern Medical Center |
| ClinicalTrials.gov Identifier: | NCT00645840 |
Purpose
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 |
|---|---|---|
|
Type 1 Diabetes Mellitus |
Drug: Anakinra |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 6 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| Children's Medical Center | |
| Dallas, Texas, United States, 75235 | |
| Principal Investigator: | Soumya Adhikari, MD | UT Southwestern Medical Center |
More Information
| Responsible Party: | Soumya Adhikari, MD, UT Southwestern Medical Center |
| ClinicalTrials.gov Identifier: | NCT00645840 History of Changes |
| Other Study ID Numbers: | UTSW 112007-037 |
| Study First Received: | March 25, 2008 |
| Last Updated: | August 3, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Type 1 diabetes mellitus IL1 beta Anakinra |
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases |
Immune System Diseases Anti-Inflammatory Agents Interleukin 1 Receptor Antagonist Protein Therapeutic Uses Pharmacologic Actions Antirheumatic Agents |