Rheumatoid Arthritis Clinical Trial
Official title:
Hydroxychloroquine to Improve Insulin Sensitivity in Rheumatoid Arthritis
The purpose of this study is to determine whether hydroxychloroquine (HCQ) reduces insulin resistance in non-diabetic subjects with rheumatoid arthritis (RA). The investigators will conduct a double-blind randomized crossover trial in subjects with RA to test the hypothesis that HCQ improves insulin sensitivity. The investigators will also use data from the trial to identify determinants of insulin resistance in RA. The investigators hypothesize that RA will be associated with an increased risk of insulin resistance and that independent risk factors for increased insulin resistance in RA include higher BMI, elevated acute phase reactants, greater fat to muscle ratio, and less physical activity.
Our ability to better control the pain and disability of rheumatoid arthritis (RA) now
focuses attention on reducing the impact of RA-associated comorbidities. The most common
cause of death in RA is cardiovascular (CV) disease, and the risk of myocardial infarction
and stroke are approximately doubled in RA. The determinants of CV risk in RA include
traditional CV risk factors as well as aspects of the inflammatory process defining RA. It
is likely that RA-associated inflammation accelerates atherosclerosis through direct effects
on the endothelium as well as indirect effects on insulin metabolism. Several studies report
an increased prevalence of insulin resistance among persons with RA. However, it is not
clear whether the inflammation of RA causes insulin resistance. Corticosteroids and
abnormalities in the hypothalamic-pituitary axis may also contribute to abnormal glucose
metabolism. Little information is available to guide management of a pre-diabetic insulin
resistance state in RA.
Hydroxychloroquine (HCQ), a commonly used medicine early in RA, may play a role in improving
insulin resistance. Several previous trials demonstrated the ability of HCQ to reduce blood
glucose levels in diabetics, and a large epidemiologic study found that subjects with RA
using HCQ were less likely to develop diabetes. In animal models, anti-malarials lower blood
glucose through slowing insulin metabolism.
With CV disease a major comorbidity in RA and insulin resistance possibly a major
determinant of CV risk, intervention studies need to begin to translate prior work into
clinical therapeutics.
Relevance: If this study demonstrates a beneficial effect of HCQ on insulin resistance among
the randomized subjects, this would provide strong evidence that HCQ has benefits beyond RA
and SLE disease activity. Currently, HCQ is stopped in many patients as they "step-up" to
more aggressive DMARD treatments, or HCQ may never be tried in some patients who present
with RA carrying with poor prognosis. If HCQ improves insulin sensitivity, there may be
rationale for continuing HCQ chronically in patients with RA. As well, a larger clinical
endpoint study would be strongly considered.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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