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Skeletal Muscle Dysfunction in Rheumatoid Arthritis (RA)

Sponsored by University of Alabama at Birmingham

Phase Quota
Phase 0

Muscle strength helps determine a person's quality of life and functional independence. Patients with rheumatoid arthritis often suffer from muscle weakness and a pre-diabetic condition called insulin resistance. By doing this study, the investigators hope to learn why patients with rheumatoid arthritis (RA) suffer from muscle weakness.

Study Start Date: September 2015

Estimated Completion Date: December 2018

Specialties: Internal Medicine: Rheumatology Nursing: Ortho/Rheum Rheumatology: Rheumatoid Arthritis Orthopedics: Arthritis/Rheumatology Physician Assistant: Rheumatology

Interventions

  • Other: Active Comparator
  • Drug: Placebo
  • Drug: Pioglitazone

Inclusion criteria

  • For RA patients (arm-1):
    • Age 25-65
    • Diagnosed with RA by a Rheumatologist and according to American College of Rheumatology 2010 criteria
  • For controls (arm-1):
    • Age 25-65
    • In generally good health
  • RA patients with insulin resistance (pioglitazone study - arm-2):
    • Age 25-65
    • Diagnosed with RA by a Rheumatologist and according to American College of Rheumatology 2010 criteria
    • Insulin resistant according to the Matsuda index

Exclusion criteria

  • For (arm-1):
    • Age 65\
    • Pregnant, breast-feeding, cognitive dysfunction, incarcerated or otherwise vulnerable persons
    • Any acute or chronic medical or psychiatric disorder that, in the opinion of the investigators, would impair evaluation of the study measures
  • For (pioglitazone study - arm 2):
    • Women of reproductive age who are pregnant or who do not agree to effective birth control or who are lactating
    • Clinically significant hepatic, cardiac or renal impairment
    • Untreated osteoporosis
    • Active cancer other than skin cancer
    • Use of drugs (other than glucocorticoids) or nutritional supplements known to affect skeletal muscle mass
    • Participation in regular and intense physical training
    • Severe edema
  • For the muscle biopsy (in arms-1 and -2):
    • Bleeding diathesis or chronic anticoagulant therapy
    • Unable or unwilling to discontinue aspirin or non-steroidal anti-inflammatory drugs for 5 days prior to muscle biopsy

Study Locations And Contact Information

  • University of Kentucky, Lexington Kentucky
    Contact: Beatriz Hanaoka 859-323-8740 byhanaoka@uky.edu

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