Randomized Study of Intravenous Immunoglobulin (IVIg) in Patients With Subacute Proximal Diabetic Neuropathy
immune globulin
Diabetes Mellitus+8
+ Enfermedades del Sistema Endocrino
+ Enfermedades del sistema nervioso
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de febrero de 1998
Fecha en la que se inscribió al primer participante.PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are randomized to treatment with low dose intravenous immunoglobulin (IVIg), high dose IVIg, or placebo. Patients must first complete baseline evaluation. Patients receive IVIg or placebo on days 1, 2, 3, and 5, biweekly at weeks 2-4, weekly at weeks 5-8, and every other week at weeks 9-12. Patients are assessed at 6, 12, 36, 52, and 104 weeks. Completion date provided represents the completion date of the grant per OOPD records
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 75 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnostically proven non-insulin dependent diabetes mellitus as defined by the following criteria: Presence of classic symptoms, such as polyuria, polydipsia, ketonuria, and rapid weight loss, together with plasma glucose elevations Elevated fasting glucose concentration on more than one occasion Diagnostically proven proximal diabetic neuropathy with any of the following symptoms: Severe thigh, hip, or leg pain Greater than 20% weight loss Progressive proximal weakness in the painful leg Weakness in the contralateral lower limb Thoracic or cervical root distribution Symmetric distal polyneuropathy or autonomic neuropathy may be mild or absent --Prior/Concurrent Therapy-- At least 6 months since prior immunosuppression or plasma exchange No history of prior renal transplant --Patient Characteristics-- Age: 18 and over Performance status: Gait impairment at least grade 2 Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine no greater than 1.4 mg/dL (women) Creatinine no greater than 1.5 mg/dL (men) No history of renal failure Cardiovascular: No history of cardiac failure Neurologic: Normal nerve conduction studies or changes compatible with distal symmetric diabetic neuropathy or diabetic lumbosacral radioplexus neuropathy Spinal fluid cell count less than 5 cells/mm3 Normal cerebral spinal fluid cytology No structural spine disease No inherited neuropathy Other: Electromyographic evidence of proximal lower limb plexus OR Radicular denervation compatible with proximal diabetic neuropathy No other systemic disease or malignancy Normal IgA levels No chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) No systemic amyloidosis No monoclonal gammopathy associated neuropathy No history of allergy to serum products No selective cervical or root involvement without lower limb weakness No evidence of secondary diabetes