Inflammation and Insulin Resistance in Rheumatoid Arthritis
| Status: | Archived |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis, Endocrine |
| Therapuetic Areas: | Endocrinology, Rheumatology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | April 2009 |
| End Date: | September 2012 |
Rheumatoid arthritis (RA) is a form of arthritis that causes pain, swelling, stiffness, and
loss of function in the joints. Over time, joint deformity, joint destruction, and loss of
function can occur. Current treatment aims to improve symptoms, but there is no cure for the
disease. Pioglitazone is drug that is effective in treating people with diabetes. This study
will determine whether pioglitazone can also be used to effectively treat people with RA.
RA is an autoimmune disease that causes long-term inflammation of the joints and sometimes
other body tissues, too. Recent studies have found that there is an increased prevalence of
coronary artery atherosclerosis, metabolic syndrome, and insulin resistance among people
with RA. Furthermore, insulin resistance, which can lead to hyperinsulinemia—too much
insulin in the blood—has been associated with RA disease activity and the severity of
coronary artery atherosclerosis. These correlations suggest that inflammation and
hyperinsulinemia somehow interact and facilitate one another.
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.
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