Diabetes Mellitus Clinical Trial
Official title:
Treatment With Gamunex 10% Intravenous Immunoglobulin (IVIg) for Patients With Demyelination and Diabetes Mellitus: A Blinded, Placebo-Controlled Crossover Pilot Study
The purpose of this study is to determine whether intravenous immunoglobulin (IVIg) is an effective intervention for patients with diabetes, peripheral neuropathy, and demyelination on nerve conduction studies. All patients will receive both IVIg and placebo for 3 months each, with a 3 month washout period in between.
There is a knowledge gap with regards to the appropriate method of detecting and treating
chronic inflammatory demyelinating polyneuropathy (CIDP), in patients with co-existent
diabetes. In this pilot study the investigators plan to examine the overlap between diabetic
polyneuropathy and CIDP by treating patients with diabetes and demyelinating abnormalities
using IVIg. The investigators will enroll diabetes patients with a broad spectrum of
demyelinating abnormalities.
The proposed trial will be an explanatory, blinded, single-centre, superiority, randomized
controlled cross-over trial. Each patient will receive 3 months of 10% intravenous
immunoglobulin and 3 months of placebo (0.9% sodium chloride in water) with a 3-month
washout period. The primary outcome measure is the mean change in ONLS (Overall Neuropathy
Limitation Scale), a measure of disability in polyneuropathy; however secondary outcome
measures will consider impairments and quality of life.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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