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Low Dose Cyclosporin and Methotrexate Therapy in Diabetes

Information source: Georgetown University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 1 Diabetes Mellitus

Intervention: cyclosporin and methotrexate (Drug)

Phase: N/A

Status: Completed

Sponsored by: Georgetown University

Official(s) and/or principal investigator(s):
Douglas Sobel, MD, Principal Investigator, Affiliation: Georgetown University

Summary

The purpose of this study is to determine whether treatment with low dose cyclosporin and methotrexate can inhibit the development of new onset diabetes mellitus

Clinical Details

Official title: Low Dose Cyclosporin and Methotrexate Therapy in New Onset Diabetes Mellitus

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: insulin dose

Secondary outcome: renal function

Detailed description: Objective: Although high doses of cyclosporin (cyclo) inhibits the development of type 1 diabetes mellitus, its usefulness is limited by its toxicity. Since methotrexate (mtx) and cyclo synergistically inhibit other disease processes, we hypothesized that low dose cyclo and mtx therapy could safely induce remission. Research Design and Methods: In an open pilot study, insulin dose and glycemic control will be compared in children with new onset Type 1 diabetes administered cyclo at 7. 5 mg/kg/day for 6 weeks and then 4 mg/kg/day and mtx 5 mg/kg/day for one year with control children. After 6 weeks, doses were adjusted to maintain blood cyclo levels to 100-200 ng/ml.

Eligibility

Minimum age: 8 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of Type1 diabetes mellitus and be obtaining insulin therapy for less than 4

weeks Exclusion Criteria:

- Ketoacidosis

- Body weight over 110% of ideal weight

- Condition where immunosuppression is contraindicated

- Abnormal liver or renal function tests

Locations and Contacts

Georgetown University, Washington DC, District of Columbia 20007, United States
Additional Information

Starting date: February 1990
Last updated: April 12, 2011

Page last updated: August 23, 2015

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