Inflammation and Insulin Resistance in Rheumatoid Arthritis
NCT ID: NCT00763139
Last Updated: 2014-11-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
34 participants
INTERVENTIONAL
2009-04-30
2013-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Pioglitazone is a prescription drug that reduces insulin resistance and is currently used to treat people with diabetes. This study will determine whether pioglitazone can also be used to effectively treat people with RA. Specifically, the study will evaluate the effect of pioglitazone on inflammation, insulin resistance, and atherosclerosis.
Participation in this study will last about 20 weeks. At an initial 1-hour screening, participants will undergo a physical examination, medical history review, blood sampling, and, if female, a urine pregnancy test. Eligible participants will then return for the first of six monthly study visits. At this first visit, participants will be randomly assigned to receive either pioglitazone or placebo, both of which will be taken daily for 8 weeks. This will be followed by a 4-week wash-out period, during which no study treatments will be taken. Then, at Week 12, participants will begin daily treatments of whatever they were not assigned to originally. This second treatment phase will also last for 8 weeks.
All of the study visits will involve the same tests and procedures. The morning before each study visit, participants will collect their urine in a jug, which they will bring to the clinic. Participants will then undergo blood sampling, blood pressure measurements, and artery stiffness measurements. During the study visits at Weeks 4, 8, 16, and 20, participants will be asked to report on their symptoms, pain, and any adverse effects.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo First
Placebo for first 8 weeks, then washout period for 4 weeks, and finally pioglitazone for 8 weeks.
Pioglitazone
45 mg by mouth once a day for 8 weeks
Placebo
By mouth once a day for 8 weeks
Pioglitazone First
Pioglitazone for first 8 weeks, then washout period for 4 weeks, and finally placebo for 8 weeks.
Pioglitazone
45 mg by mouth once a day for 8 weeks
Placebo
By mouth once a day for 8 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pioglitazone
45 mg by mouth once a day for 8 weeks
Placebo
By mouth once a day for 8 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Stable disease activity, as evidenced by no change in immunomodulating or anti-inflammatory therapy in the 1 month before study entry
* Moderate disease activity, as reflected by a minimum of three swollen and tender joints
* If female of childbearing potential, willing to use effective method of contraception
Exclusion Criteria
* Active cancer (other than skin cancer)
* HIV infected
* Currently receiving dialysis
* Received an organ or bone marrow transplant
* Heart failure
* Severe edema, as judged by the principal investigator
* Diabetes mellitus requiring drug therapy: levels of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than twice the upper limit of normal
* Underwent major surgery in the 3 months before study entry
* Severe comorbid condition that is likely to compromise survival or study participation
* Currently receiving gemfibrozil or rifampin
* Osteoporosis and not receiving osteoporosis medications
* Unwillingness, or other inability, to cooperate with study procedures
* Pregnancy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
Vanderbilt University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
C. Michael Stein
Dan May Professor of Medicine, Professor of Pharmacology, Associate Director of the Division of Clinical Pharmacology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Charles M. Stein, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vanderbilt Clinical Research Center
Nashville, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.