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Skeletal Muscle Dysfunction in Rheumatoid Arthritis (RA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02535832
Recruitment Status : Recruiting
First Posted : August 31, 2015
Last Update Posted : May 9, 2022
Sponsor:
Information provided by (Responsible Party):
Beatriz Hanaoka, University of Alabama at Birmingham

Brief 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.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Insulin Resistance Drug: Pioglitazone Drug: Placebo Phase 1

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Placebo
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.
Drug: Pioglitazone
Pioglitazone CT Scan DXA scan Needle muscle biopsy
Other Name: Actos




Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: Baseline ]
    2 hour oral glucose tolerance test will be performed after a 12-hour fast using 75 g glucose

  2. 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)

  3. Monocytosis in peripheral blood [ Time Frame: Changes from baseline and 12 weeks ]
    White blood cell populations will be isolated using flow cytometry.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Beatriz Hanaoka, MD MPH 614-685-5364 beatriz.hanaoka@osumc.edu

Locations
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United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Beatriz Hanaoka, MD MPH    614-685-5364    beatriz.hanaoka@osumc.edu   
Contact: Benton E Carter    614-685-8068    benton.carter@osum.edu   
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Beatriz Hanaoka, MD MPH Ohio State University
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Responsible Party: Beatriz Hanaoka, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02535832    
Other Study ID Numbers: 15-0585-F6A
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: May 9, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beatriz Hanaoka, University of Alabama at Birmingham:
Rheumatoid Arthritis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Insulin Resistance
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs