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| Descriptive Information Fields | |||||
| Brief Title † | Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus | ||||
| Official Title † | Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus | ||||
| Brief Summary | A study to examine the effect of pioglitazone on the course of new onset type 1 diabetes mellitus. |
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| Detailed Description | Thiazolidinediones have been shown to reduce the development of diabetes mellitus in animal models of type 1 diabetes and to reduce the death of beta cells (cells that make insulin) in petri dishes. Pioglitazone is a thiazolidinedione currently approved for the treatment of type 2 diabetes. This study explores the question of whether pioglitazone can preserve beta cell function in patients with recently diagnosed type 1 diabetes mellitus. |
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| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | C-peptide response to a Sustacal meal [ Time Frame: 6 months ] | ||||
| Secondary Outcome Measure † | Insulin requirement [ Time Frame: 6 months ] Hemoglobin A1c [ Time Frame: 6 months ] |
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| Condition † | Type 1 Diabetes Mellitus | ||||
| Intervention † | Drug: pioglitazone Drug: Placebo control |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
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| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 6 Years to 18 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00545857 | ||||
| Organization ID | 20064114 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Stony Brook University | ||||
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| Information Provided By | Stony Brook University | ||||
| Verification Date | October 2007 | ||||
| First Received Date † | October 16, 2007 | ||||
| Last Updated Date | October 16, 2007 | ||||