We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

IVIg for Demyelination in Diabetes Mellitus (IDIDM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02372149
Recruitment Status : Unknown
Verified November 2016 by Ari Breiner, MD, University of Toronto.
Recruitment status was:  Recruiting
First Posted : February 26, 2015
Last Update Posted : November 11, 2016
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
Ari Breiner, MD, University of Toronto

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Peripheral Neuropathy Diabetes Mellitus Chronic Inflammatory Demyelinating Polyneuropathy Drug: 10% intravenous immunoglobulin (IVIg) Drug: 0.9% sodium chloride Phase 4

Detailed Description:

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment With Gamunex 10% Intravenous Immunoglobulin (IVIg) for Patients With Demyelination and Diabetes Mellitus: A Blinded, Placebo-Controlled Crossover Pilot Study
Study Start Date : February 2015
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: IVIg--Washout--0.9% NaCl (CROSSOVER)
  1. 10% caprylate-chromatography purified intravenous immunoglobulin (IVIg) Initial dose: 1.0gm/kg/day for 2 days (maximum 80gm/day). Maintenance dose (monthly x3): 1.0mg/kg/day for 1 day (maximum 80gm/day)
  2. Washout period
  3. 0.9% sodium chloride in water - equal volume to IVIg - Monthly x4
 Drug: 10% intravenous immunoglobulin (IVIg)
Other Name: Gamunex

Drug: 0.9% sodium chloride
Other Name: Normal Saline
Experimental: 0.9% NaCl--Washout--IVIg (CROSSOVER)
  1. 0.9% sodium chloride in water - equal volume to IVIg - Monthly x4
  2. Washout period
  3. 10% caprylate-chromatography purified intravenous immunoglobulin (IVIg) Initial dose: 1.0gm/kg/day for 2 days (maximum 80gm/day). Maintenance dose (monthly x3): 1.0mg/kg/day for 1 day (maximum 80gm/day)
 Drug: 10% intravenous immunoglobulin (IVIg)
Other Name: Gamunex

Drug: 0.9% sodium chloride
Other Name: Normal Saline


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in Overall Neuropathy Limitations Score (ONLS) after 3 months [ Time Frame: Baseline and 3 months ]
    ONLS score will be measured before and after 3 months of IVIg / placebo


Secondary Outcome Measures :
  1. Change in Rasch-Built Overall Disability Scale (R-ODS) after 3 months [ Time Frame: Baseline and 3 months ]
    R-ODS score will be measured before and after 3 months of IVIg / placebo

  2. Change in Nerve Conduction Studies (NCS) after 3 months [ Time Frame: Baseline and 3 months ]
    Changes in NCS parameters will be compared before and after 3 months of IVIg / placebo

  3. Change in Medical Research Council (MRC) Sum Score after 3 months [ Time Frame: Baseline and 3 months ]
    MRC sum score will be compared before and after 3 months of IVIg / placebo

  4. Change in Grip Strength after 3 months [ Time Frame: Baseline and 3 months ]
    Grip strength (using Martin vigorimeter) will be compared before and after 3 months of IVIg / placebo

  5. Change in Short Form 36 (SF-36) Quality of Life after 3 months [ Time Frame: Baseline and 3 months ]
    SF-36 will be compared before and after 3 months of IVIg / placebo

  6. Adverse Events [ Time Frame: 30 days ]
    Number of adverse events and serious adverse events within 30 days of IVIg administration


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years.
  2. Diabetes, as per American Diabetes Association Criteria.

  3. Clinical evidence of polyneuropathy and NCS shows 2 separate motor nerves (median, ulnar, tibial, or peroneal) which meet criteria for demyelination, defined as follows:

    1. Conduction velocity <90% lower limit of normal (LLN), distal latency >110% upper limit of normal (ULN), or minimal F-wave latency >110% ULN
    2. The changes are not exclusively due to median neuropathy at the wrist, ulnar neuropathy at the elbow, or peroneal neuropathy at the fibular head.
  4. Clinical suspicion of possible demyelinating polyneuropathy (CIDP).

Exclusion Criteria:

  1. Pregnant patients, or those of childbearing potential not using contraception.
  2. Patients <18 years of age.
  3. Presence of an alternative etiology of peripheral neuropathy, such as: hereditary neuropathies (Charcot Marie-Tooth disease); B-vitamin deficiency- or excess-related neuropathy; uremic neuropathy; neuropathy secondary to monoclonal gammopathy; history of cancer- or chemotherapy-related neuropathy; other toxin exposures; and alcoholic neuropathy.
  4. Contraindication to IVIg, including: history of recurrent thrombosis, immunoglobulin A deficiency, or severe hypersensitivity reaction to IVIg in past, renal failure, recurrent deep venous thrombosis, pulmonary embolus, stroke, or myocardial infarction.
  5. Presence of serious or unstable medical condition, which may preclude study completion or lead to inability to tolerate IVIg. This may include active heart failure, uncontrolled hypertension, or severe anemia, among other conditions.
  6. Presence of concomitant neurological illness, which may confound evaluation.
  7. Fails or unable to provide informed consent.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372149


Contacts
Layout table for location contacts
Contact: Eduardo Ng, MD 416-340-4184 eduardo.ng@uhn.ca

Locations
Layout table for location information
Canada, Ontario
Toronto General Hospital / Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Eduardo Ng, MD    416-340-4184    eduardo.ng@uhn.ca   
Sponsors and Collaborators
University of Toronto
University Health Network, Toronto
Investigators
Layout table for investigator information
Principal Investigator: Ari Breiner, MD, FRCPC University of Toronto
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ari Breiner, MD, Assistant Professor of Medicine (Neurology), University of Toronto
ClinicalTrials.gov Identifier: NCT02372149    
Other Study ID Numbers: 14-8297-B
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Nervous System Diseases
Polyneuropathies
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Demyelinating Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neuromuscular Diseases
Nervous System Diseases
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
 Autoimmune Diseases
Immune System Diseases
Chronic Disease
Disease Attributes
Pathologic Processes
Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs