Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2025-12-24 @ 9:29 PM
NCT ID:
NCT02535832
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
65 Years
Study:
NCT02535832
Study Brief:
Protocol Section:
NCT02535832