Relapsing Remitting Multiple Sclerosis Clinical Trial
Official title:
Assessment of the Clinical Importance of Insulin Resistance & Steroid-Associated Hyperglycemia in Relapsing Multiple Sclerosis
The purpose of this study is to assess the relationship of blood glucose levels in persons
with Multiple Sclerosis (MS) who have experienced a relapse and will be receiving intravenous
steroids for the relapse, to their recovery from the relapse.
Steroid exposure commonly leads to elevated serum blood glucose, however, standardized
monitoring of blood glucose levels in the outpatient setting is not common. The clinical
impact of any associated elevated blood glucose during steroid administration is unknown. We
hypothesize that the blood glucose response to steroid treatment is clinically relevant to
the MS-relapse recovery.
Multiple Sclerosis (MS) is a neuroinflammatory and degenerative central nervous system
disorder. The majority of patients have an early relapsing-remitting course. Standard
treatment for an MS-relapse is intravenous methylprednisolone (IVMP), typically 1000 mg daily
for 3 days. Despite IVMP treatment, >40% of MS patients experience residual deficits after an
MS-relapse. Potential risk factors for poor relapse recovery remain unclear.
Elevated serum blood glucose is a common and well-defined consequence of steroid
administration, attributed to steroid-related reductions in insulin sensitivity. Individuals
with pre-treatment insulin resistance (e.g. diabetics) will exhibit an amplified
hyperglycemic response. Reduced mobility, sedentary lifestyle, and repeated exposure to
steroids- all of which are common in MS - are recognized risk factors for insulin resistance.
These factors may make MS patients particularly susceptible to steroid-induced hyperglycemia.
While, MS patients commonly receive intravenous steroids, the clinical impact of any
associated hyperglycemia is unknown.
Study Design and Methods Timeline: Study will require 3 visits over a 6 month period.
Subjects: MS subjects who are experiencing an acute relapse will be recruited for the study.
Prior to any study procedures, the PI or research coordinator will obtain full written
informed consent.
Baseline Measurements: age, race/ethnicity, sex, weight, height, waist circumference, blood
pressure, previous steroid exposure (dates, frequency, steroid type and dose), smoking
history, and family history of diabetes. Medication review will include MS disease-modifying
therapy, symptomatic medications, and non-MS-related medications. Additional MS-related
information will include dates of initial MS-symptom onset, MS diagnosis, and onset of
presenting relapse symptoms.
Oral glucose tolerance test (OGTT) & Matsuda Index: Prior to steroid administration, MS
subjects will undergo a 2-hour OGTT. OGTT and Matsuda Index will then be repeated at the 3-
and 6-month follow-up visits.
Blood studies: HgA1c (hemoglobin A1C), a fasting lipid panel (LDL-C, HDL-C, triglycerides,
and total cholesterol), insulin growth factor, vitamin D level, adiponectin level,
homocysteine level, and leptin level. All laboratory tests completed at baseline, 3- and
6-month visits.
Surveys: Subjects will complete surveys related to their perceived disability, relapse
severity and recovery, and other MS-related symptoms.
Functional testing: EDSS, MS Functional Composite, timed-walk testing, accelerometry, low
contrast visual acuity test (LCVA) and the symbol digit modality test (SDMT).
Intravenous steroid treatment: Standardized 1000 mg of intravenous methylprednisolone (IVMP)
daily for 3 days (reconstituted in 0.9% sodium chloride). IVMP will be billed to patient
insurance as part of routine clinical care.
Blood glucose monitoring: Bayer Contour Next glucometer will be used to measure capillary BG
levels 6 times daily (Subjects will be instructed to check their BG starting on the day of
screening and to continue BG checks (as above) until their return appointment 5-7 days after
steroid treatment completion for a total of 8-10 days. Subjects will be required to avoid
snacks between meals for the 3 days of IVMP treatment.
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