Recruiting

Observational Study

Sponsor:

University of Virginia

Code:

NCT03004079

Conditions

Relapsing Remitting Multiple Sclerosis

Clinically Isolated Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Not accepted

Study Details

Brief 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.

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.

Conditions

Relapsing Remitting Multiple Sclerosis

Clinically Isolated Syndrome

Study ID

NCT03004079

Start date

Oct, 2016

Status verified date

Nov, 2018

Completion date

Sep, 2020

Anticipated

Primary completion date

Sep, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Relapse Recovery & Hyperglycemia [ Time Frame: Recovery from relapse at 6-months ]
  • Insulin Resistance & Relapse Severity [ Time Frame: At Baseline ]

Central Contacts and Locations

Central contacts

Myla Goldman, MD

434-243-6069

Rachael Coleman, MPH

434-297-4102rcoleman@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Rachael Coleman, MPH

434-297-4102rcoleman@virginia.edu

Principal Investigator:

Myla Goldman, MD

More Information

Sponsor

University of Virginia

Last update posted

Nov 7, 2018

Last verified

Nov, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2018-11-07.