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CompletedNCT01067573LeptinUpdated Jun 18, 2012

The Role of Serum Leptin Levels in Multiple Sclerosis Disease Activity While on Interferon Beta 1a (Rebif) Treatment

An observational study in Multiple Sclerosis, sponsored by University of South Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-18.

Sponsored by University of South Florida · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 60 Years
Sex
All
01

Study summary

To determine a correlation between serum leptin levels, nitric oxide preceding a relapse and change in leptin and nitric oxide levels during exacerbation in relapsing remitting multiple sclerosis patients.

Read the detailed description

This is an observational pilot study in patients with definitive relapsing-remitting multiple sclerosis to determine whether there is a correlation in serum leptin levels and serum nitric oxide levels during a clinically observed increase in disease activity. Each subject will followed for 12 months while taking interferon beta-1a subcutaneous injections 3 times a week.

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Conditions studied

  • Multiple Sclerosis

Keywords

  • MS
  • Serum Leptin Levels during relapse
  • Multiple sclerosis
  • relapse
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In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 20 is below the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

University of South Florida is the lead sponsor of 333 studies on the registry; 63 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

USF Medical Clinic Tampa, Flrida

Inclusion criteria

  • Confirmed diagnosis of multiple sclerosis per update of McDonald criteria
  • Initiating treatment with interferon beta 1a subcutaneous injection with minimal dosing of 22mcg.
  • 18-60 years of age.
  • Women who are not pregnant or breast feeding, and who do not intend to become pregnant.
  • Stable dose of concomitant medications for 30 days prior to baseline. Efforts should be made to maintain steady doses of concomitant medications for the duration of the study.

Exclusion criteria

Exclusion Criteria:

  • Treatment on other interferon preparations, glatiramer acetate, in last 30 days or 6 months on Natalizumab, mitoxantrone, cyclosporine or other immunomodulators as determined by the PI.
  • Treatment with any other investigational treatments within the past year or treatment with any investigational treatments for multiple sclerosis within the last year.
  • Any progressive form of MS.
  • Known Hypersensitivity to interferon beta 1a.
  • Inability to administer subcutaneous injections
  • Inability to undergo laboratory evaluation.
  • Seropositivity for HIV (by medical history)
  • Diabetes Mellitus Tyle I or II (by medical history)
  • Hepatitis B or C (by medical history)
  • Uncontrolled psychiatric disorder.
  • Any unstable illness that the investigator's opinion precludes participation in this study.
  • Inability to maintain compliance with study protocol.
  • Implanted devices or metal which would contraindicate MRI.
  • Clinically significant abnormalities in CBC or CMP
  • MMSE \<25
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Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
20 participants (actual)
06

What researchers measure

Primary outcomes

  1. Fasting leptin and nitric oxide testing

    Time frame: monthly, for 12 months

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Study locations

1 site
  • USF Health
    Tampa, Florida 33612, United States
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References and documents

Publications

  • De Rosa V, Procaccini C, La Cava A, Chieffi P, Nicoletti GF, Fontana S, Zappacosta S, Matarese G. Leptin neutralization interferes with pathogenic T cell autoreactivity in autoimmune encephalomyelitis. J Clin Invest. 2006 Feb;116(2):447-55. doi: 10.1172/JCI26523. Epub 2006 Jan 12. PubMed 16410832 ↗
  • Musio S, Gallo B, Scabeni S, Lapilla M, Poliani PL, Matarese G, Ohtsu H, Galli SJ, Mantegazza R, Steinman L, Pedotti R. A key regulatory role for histamine in experimental autoimmune encephalomyelitis: disease exacerbation in histidine decarboxylase-deficient mice. J Immunol. 2006 Jan 1;176(1):17-26. doi: 10.4049/jimmunol.176.1.17. PubMed 16365391 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01067573
Lead sponsor
University of South Florida
Collaborators
EMD Serono
Responsible party
Sponsor
First posted
Feb 11, 2010
Start date
Dec 2009
Completion
Jul 2011
Last update
Jun 18, 2012

Study contacts

Stanley J Krolczyk, DO, RPH
principal investigator · University of South Florida

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

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