Skeletal Muscle Dysfunction in Rheumatoid Arthritis (RA)

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ohio State University; University of Alabama at Birmingham
• Treatments: Pioglitazone

Criteria

Inclusion Criteria for RA patients (cross-sectional study):

• Age 35-65

• Diagnosed with RA by a Rheumatologist and according to American College of Rheumatology 2010 criteria

Inclusion Criteria for controls (cross-sectional study):

• Age 35-65

• In generally good health

Inclusion Criteria for RA patients who are: (i) insulin resistant by the 2-hour glucose tolerance test; (ii) have the presence of 3 or more risk factors for metabolic syndrome (MetS) according to the ATP III Clinical Identification of MetS criteria; (iii) have a Hemoglobin A1c level equal or greater than 5.7 and less than 6.5.

• Age 35-65

• Diagnosed with RA by a Rheumatologist and according to American College of Rheumatology 2010 criteria

• Insulin resistant according to the Matsuda index

Exclusion Criteria (cross-sectional study):

• Age <35 or >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

Exclusion criteria (pioglitazone randomized clinical trial):

• 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.

Exclusion criteria for the muscle biopsy (cross-sectional and pioglitazone randomized clinical trial):

• 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