Relapsing Remitting Multiple SclerosisNCT03004079
Clinical Importance of Glucose Regulation in Relapsing MS
An observational study of Relapsing Remitting Multiple Sclerosis and Clinically Isolated Syndrome, run by University of Virginia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis, Clinically Isolated Syndrome
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults aged 18-54 (inclusive) with a diagnosis of clinically isolated syndrome or relapsing remitting multiple sclerosis with an acute attack (relapse).
Who may be able to join
- Ability to provide informed consent
- Age 18 -59 years (inclusive)
- Ability to walk continuously for 6 minutes (per patient report)
- Clinically Isolated Syndrome (CIS) or Relapsing Remitting MS (RRMS) confirmed diagnosis by McDonald 2010 criteria
- Current MS relapse with objective findings on exam
- Relapse symptom onset within 2-weeks of screening
Show all 9Show fewer
- Functional System Scores obtainable from a clinic visit within 6 months of the relapse assessment visit
- EDSS < 6.5 at time of screening visit
- Inpatient, outpatient, emergency department, or inpatient observation status
Who cannot join
- Prior steroid exposure within 90 days of enrollment
- HgA1c ≥ 6.5 at baseline screening
- Evidence of concurrent infection
- Known contraindications to IV steroid treatment
- History of diabetes mellitus ( type 1 or 2) or severe hypertension
- Use of any glucose-regulating medications
- Pregnancy or current use of hormone replacement therapy
Trial locations and contacts
1 site in 1 country.
Myla Goldman, MD contact
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Rachael Coleman, MPH, 434-297-4102, rcoleman@virginia.edu
Myla Goldman, MD
About this study
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.
Read the detailed description
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.
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse Recovery & Hyperglycemia
Determine the relationship between mean postprandial blood glucoses (BG) and relapse recovery (complete vs. incomplete) following a standardized IVMP treatment.
Measured: Recovery from relapse at 6-months
Insulin Resistance & Relapse Severity
Determine if insulin resistance (IR), measured by the Matsuda Index, is an independent predictor of relapse severity.
Measured: At Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Principal investigator, Myla Goldman, MD, University of Virginia
- Investigators
- Myla Goldman, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004079
- Sponsor's protocol ID
- 19259
- Status last verified
- Nov 2018
- First submitted
- 2 Nov 2016
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Nickerson M, Marrie RA. The multiple sclerosis relapse experience: patient-reported outcomes from the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry. BMC Neurol. 2013 Sep 10;13:119. doi: 10.1186/1471-2377-13-119.
PubMed 24016260Hirst C, Ingram G, Pearson O, Pickersgill T, Scolding N, Robertson N. Contribution of relapses to disability in multiple sclerosis. J Neurol. 2008 Feb;255(2):280-7. doi: 10.1007/s00415-008-0743-8. Epub 2008 Jan 23.
PubMed 18204919Lublin FD, Baier M, Cutter G. Effect of relapses on development of residual deficit in multiple sclerosis. Neurology. 2003 Dec 9;61(11):1528-32. doi: 10.1212/01.wnl.0000096175.39831.21.
PubMed 14663037Kwon S, Hermayer KL, Hermayer K. Glucocorticoid-induced hyperglycemia. Am J Med Sci. 2013 Apr;345(4):274-277. doi: 10.1097/MAJ.0b013e31828a6a01.
PubMed 23531958Johnston KC, Hall CE, Kissela BM, Bleck TP, Conaway MR; GRASP Investigators. Glucose Regulation in Acute Stroke Patients (GRASP) trial: a randomized pilot trial. Stroke. 2009 Dec;40(12):3804-9. doi: 10.1161/STROKEAHA.109.561498. Epub 2009 Oct 15.
PubMed 19834016Baker L, Juneja R, Bruno A. Management of hyperglycemia in acute ischemic stroke. Curr Treat Options Neurol. 2011 Dec;13(6):616-28. doi: 10.1007/s11940-011-0143-8.
PubMed 21861124Southerland AM, Johnston KC. Considering hyperglycemia and thrombolysis in the Stroke Hyperglycemia Insulin Network Effort (SHINE) trial. Ann N Y Acad Sci. 2012 Sep;1268(1):72-8. doi: 10.1111/j.1749-6632.2012.06731.x.
PubMed 22994224Bruno A, Biller J, Adams HP Jr, Clarke WR, Woolson RF, Williams LS, Hansen MD. Acute blood glucose level and outcome from ischemic stroke. Trial of ORG 10172 in Acute Stroke Treatment (TOAST) Investigators. Neurology. 1999 Jan 15;52(2):280-4. doi: 10.1212/wnl.52.2.280.
PubMed 9932944Fang Y, Zhang S, Wu B, Liu M. Hyperglycaemia in acute lacunar stroke: a Chinese hospital-based study. Diab Vasc Dis Res. 2013 May;10(3):216-21. doi: 10.1177/1479164112459663. Epub 2012 Oct 18.
PubMed 23079541Matute C, Domercq M, Perez-Samartin A, Ransom BR. Protecting white matter from stroke injury. Stroke. 2013 Apr;44(4):1204-11. doi: 10.1161/STROKEAHA.112.658328. Epub 2012 Dec 4. No abstract available.
PubMed 23212168Wens I, Dalgas U, Deckx N, Cools N, Eijnde BO. Does multiple sclerosis affect glucose tolerance? Mult Scler. 2014 Aug;20(9):1273-6. doi: 10.1177/1352458513515957. Epub 2013 Dec 17.
PubMed 24347183Sternberg Z, Leung C, Sternberg D, Li F, Karmon Y, Chadha K, Levy E. The prevalence of the classical and non-classical cardiovascular risk factors in multiple sclerosis patients. CNS Neurol Disord Drug Targets. 2013 Feb 1;12(1):104-11. doi: 10.2174/1871527311312010016.
PubMed 23244431Marrie RA, Rudick R, Horwitz R, Cutter G, Tyry T, Campagnolo D, Vollmer T. Vascular comorbidity is associated with more rapid disability progression in multiple sclerosis. Neurology. 2010 Mar 30;74(13):1041-7. doi: 10.1212/WNL.0b013e3181d6b125.
PubMed 20350978Marrie RA, Horwitz R, Cutter G, Tyry T, Campagnolo D, Vollmer T. Comorbidity delays diagnosis and increases disability at diagnosis in MS. Neurology. 2009 Jan 13;72(2):117-24. doi: 10.1212/01.wnl.0000333252.78173.5f. Epub 2008 Oct 29.
PubMed 18971448Sellebjerg F, Frederiksen JL, Nielsen PM, Olesen J. Double-blind, randomized, placebo-controlled study of oral, high-dose methylprednisolone in attacks of MS. Neurology. 1998 Aug;51(2):529-34. doi: 10.1212/wnl.51.2.529.
PubMed 9710030
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Clinical Importance of Insulin Resistance & Steroid-Associated Hyperglycemia in Relapsing Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03004079
- Acronym / sponsor ID
- 19259
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- Oct 2016
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 28 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults aged 18-54 (inclusive) with a diagnosis of clinically isolated syndrome or relapsing remitting multiple sclerosis with an acute attack (relapse).
Key inclusion criteria (9 listed)
- Ability to provide informed consent
- Age 18 -59 years (inclusive)
- Ability to walk continuously for 6 minutes (per patient report)
- Clinically Isolated Syndrome (CIS) or Relapsing Remitting MS (RRMS) confirmed diagnosis by McDonald 2010 criteria
Key exclusion criteria (7 listed)
- Prior steroid exposure within 90 days of enrollment
- HgA1c ≥ 6.5 at baseline screening
- Evidence of concurrent infection
- Known contraindications to IV steroid treatment
- History of diabetes mellitus ( type 1 or 2) or severe hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relapse Recovery & Hyperglycemia
Time frame: Recovery from relapse at 6-months
Determine the relationship between mean postprandial blood glucoses (BG) and relapse recovery (complete vs. incomplete) following a standardized IVMP treatment.
Insulin Resistance & Relapse Severity
Time frame: At Baseline
Determine if insulin resistance (IR), measured by the Matsuda Index, is an independent predictor of relapse severity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Background: PubMed 24016260Nickerson M, Marrie RA. The multiple sclerosis relapse experience: patient-reported outcomes from the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry. BMC Neurol. 2013 Sep 10;13:119. doi: 10.1186/1471-2377-13-119.
- Background: PubMed 18204919Hirst C, Ingram G, Pearson O, Pickersgill T, Scolding N, Robertson N. Contribution of relapses to disability in multiple sclerosis. J Neurol. 2008 Feb;255(2):280-7. doi: 10.1007/s00415-008-0743-8. Epub 2008 Jan 23.
- Background: PubMed 14663037Lublin FD, Baier M, Cutter G. Effect of relapses on development of residual deficit in multiple sclerosis. Neurology. 2003 Dec 9;61(11):1528-32. doi: 10.1212/01.wnl.0000096175.39831.21.
- Background: PubMed 23531958Kwon S, Hermayer KL, Hermayer K. Glucocorticoid-induced hyperglycemia. Am J Med Sci. 2013 Apr;345(4):274-277. doi: 10.1097/MAJ.0b013e31828a6a01.
- Background: PubMed 19834016Johnston KC, Hall CE, Kissela BM, Bleck TP, Conaway MR; GRASP Investigators. Glucose Regulation in Acute Stroke Patients (GRASP) trial: a randomized pilot trial. Stroke. 2009 Dec;40(12):3804-9. doi: 10.1161/STROKEAHA.109.561498. Epub 2009 Oct 15.
- Background: PubMed 21861124Baker L, Juneja R, Bruno A. Management of hyperglycemia in acute ischemic stroke. Curr Treat Options Neurol. 2011 Dec;13(6):616-28. doi: 10.1007/s11940-011-0143-8.
- Background: PubMed 22994224Southerland AM, Johnston KC. Considering hyperglycemia and thrombolysis in the Stroke Hyperglycemia Insulin Network Effort (SHINE) trial. Ann N Y Acad Sci. 2012 Sep;1268(1):72-8. doi: 10.1111/j.1749-6632.2012.06731.x.
- Background: PubMed 9932944Bruno A, Biller J, Adams HP Jr, Clarke WR, Woolson RF, Williams LS, Hansen MD. Acute blood glucose level and outcome from ischemic stroke. Trial of ORG 10172 in Acute Stroke Treatment (TOAST) Investigators. Neurology. 1999 Jan 15;52(2):280-4. doi: 10.1212/wnl.52.2.280.
- Background: PubMed 23079541Fang Y, Zhang S, Wu B, Liu M. Hyperglycaemia in acute lacunar stroke: a Chinese hospital-based study. Diab Vasc Dis Res. 2013 May;10(3):216-21. doi: 10.1177/1479164112459663. Epub 2012 Oct 18.
- Background: PubMed 23212168Matute C, Domercq M, Perez-Samartin A, Ransom BR. Protecting white matter from stroke injury. Stroke. 2013 Apr;44(4):1204-11. doi: 10.1161/STROKEAHA.112.658328. Epub 2012 Dec 4. No abstract available.
- Background: PubMed 24347183Wens I, Dalgas U, Deckx N, Cools N, Eijnde BO. Does multiple sclerosis affect glucose tolerance? Mult Scler. 2014 Aug;20(9):1273-6. doi: 10.1177/1352458513515957. Epub 2013 Dec 17.
- Background: PubMed 23244431Sternberg Z, Leung C, Sternberg D, Li F, Karmon Y, Chadha K, Levy E. The prevalence of the classical and non-classical cardiovascular risk factors in multiple sclerosis patients. CNS Neurol Disord Drug Targets. 2013 Feb 1;12(1):104-11. doi: 10.2174/1871527311312010016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myla Goldman, MD contact
Myla Goldman, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Remitting Multiple Sclerosis and Clinically Isolated Syndrome, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Myla Goldman, MD (434-243-6069), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse Recovery & Hyperglycemia (time frame: Recovery from relapse at 6-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03004079, which also lists 47 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.