Skeletal Muscle Dysfunction in Rheumatoid Arthritis (RA)
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|ClinicalTrials.gov Identifier: NCT02535832|
Recruitment Status : Recruiting
First Posted : August 31, 2015
Last Update Posted : May 9, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis Insulin Resistance||Drug: Pioglitazone Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Skeletal Muscle Dysfunction in Rheumatoid Arthritis (RA)|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||June 2023|
Placebo Comparator: Placebo
From the total participants enrolled into the cross-sectional study, the investigator will identify up to 18 participants who have insulin resistance and recruit them to participate in the placebo arm. Participants will take matching placebo throughout the 15 weeks of treatment.
Placebo CT Scan DXA scan Needle muscle biopsy
Active Comparator: Pioglitazone
From the total participants enrolled into the cross-sectional study, the investigator will identify up to 18 participants who have insulin resistance and recruit them to participate in the pioglitazone arm. Participants will start by taking increasing doses for three weeks as follows: 1 capsule (15 mg) per day for 7 days, 1 capsule per day (30 mg) for 7 days, and 1 capsule (45mg), if tolerated. Participants will continue this dose (45 mg) throughout the 12 weeks of treatment.
Pioglitazone CT Scan DXA scan Needle muscle biopsy
Other Name: Actos
- Insulin sensitivity [ Time Frame: Baseline ]2 hour oral glucose tolerance test will be performed after a 12-hour fast using 75 g glucose
- Skeletal muscle strength in the quadriceps muscle [ Time Frame: Changes from baseline and 12 weeks ]isometric strength test of the lower-extremity muscles (with one leg extension) using a Biodex to measure maximum voluntary isometric contraction (MVIC)
- Monocytosis in peripheral blood [ Time Frame: Changes from baseline and 12 weeks ]White blood cell populations will be isolated using flow cytometry.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02535832
|Contact: Beatriz Hanaoka, MD MPHfirstname.lastname@example.org|
|Principal Investigator:||Beatriz Hanaoka, MD MPH||Ohio State University|