Low Dose Cyclosporin and Methotrexate Therapy in Diabetes
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Registration Number
- NCT00905073
- Lead Sponsor
- Georgetown University
- Brief 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- Diagnosis of Type1 diabetes mellitus and be obtaining insulin therapy for less than 4 weeks
- Ketoacidosis
- Body weight over 110% of ideal weight
- Condition where immunosuppression is contraindicated
- Abnormal liver or renal function tests
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description cyclosporin+Methotrexate cyclosporin and methotrexate cyclosporin treatment at 7.5 mg/kg/day for 6 weeks and then 4 mg/kg/day for on year and methotrexate 5 mg/kg/day for one year.
- Primary Outcome Measures
Name Time Method insulin dose one year
- Secondary Outcome Measures
Name Time Method renal function one year
Trial Locations
- Locations (1)
Georgetown University
🇺🇸Washington DC, District of Columbia, United States