Type 1 Diabetes Mellitus
Conditions
Keywords
type 1 diabetes mellitus, cyclosporin, methotrexate, renal function
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.
Interventions
DRUGcyclosporin and methotrexate
cyclosporin 7.5 mg/kg/day for 6 weeks and then 4 mg/kg/day for one year and methotrexate 5 mg/kg/day for one year. After 6 weeks, cyclosporin doses will adjusted to maintain blood cyclo levels to 100-200 ng/ml.
Sponsors
Georgetown University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| insulin dose | one year |
Secondary
| Measure | Time frame |
|---|---|
| renal function | one year |
Countries
United States
Outcome results
None listed