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| Name | Class |
|---|---|
| University Health Network, Toronto | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVIg--Washout--0.9% NaCl (CROSSOVER) | Experimental |
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| 0.9% NaCl--Washout--IVIg (CROSSOVER) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10% intravenous immunoglobulin (IVIg) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Overall Neuropathy Limitations Score (ONLS) after 3 months | ONLS score will be measured before and after 3 months of IVIg / placebo | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Rasch-Built Overall Disability Scale (R-ODS) after 3 months | R-ODS score will be measured before and after 3 months of IVIg / placebo | Baseline and 3 months |
| Change in Nerve Conduction Studies (NCS) after 3 months |
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Inclusion Criteria:
Age ≥18 years.
Diabetes, as per American Diabetes Association Criteria.
Clinical evidence of polyneuropathy and NCS shows 2 separate motor nerves (median, ulnar, tibial, or peroneal) which meet criteria for demyelination, defined as follows:
Clinical suspicion of possible demyelinating polyneuropathy (CIDP).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eduardo Ng, MD | Contact | 416-340-4184 | eduardo.ng@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Ari Breiner, MD, FRCPC | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto General Hospital / Toronto Western Hospital | Recruiting | Toronto | Ontario | M5G 2C4 | Canada |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D003920 | Diabetes Mellitus |
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 0.9% sodium chloride | Drug |
|
|
Changes in NCS parameters will be compared before and after 3 months of IVIg / placebo
| Baseline and 3 months |
| Change in Medical Research Council (MRC) Sum Score after 3 months | MRC sum score will be compared before and after 3 months of IVIg / placebo | Baseline and 3 months |
| Change in Grip Strength after 3 months | Grip strength (using Martin vigorimeter) will be compared before and after 3 months of IVIg / placebo | Baseline and 3 months |
| Change in Short Form 36 (SF-36) Quality of Life after 3 months | SF-36 will be compared before and after 3 months of IVIg / placebo | Baseline and 3 months |
| Adverse Events | Number of adverse events and serious adverse events within 30 days of IVIg administration | 30 days |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D011115 | Polyneuropathies |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |