Phase 3
Completed N=30
Hydroxychloroquine to Improve Insulin Sensitivity in Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01132118 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Insulin Sensitivity Index — 7.7; 7.7; 8.1; 7.8 (dL x L)/(mg x mIU) — p=0.930
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin Sensitivity Index |
7.7; 7.7; 8.1; 7.8; 0.4; 0.14 | 0.930 |
| SECONDARY HOMA-IR |
2.0; 2.0; 1.7; 1.6; -0.3; -0.42 | 0.575 |
| SECONDARY HOMA-B |
116.5; 116.5; 110.8; 109.7; -5.8; -6.8 | 0.468 |
| SECONDARY Total Cholesterol |
192.4; 192.4; 179.7; 189.4; -12.7; -3.0 | 0.004 sig |
| SECONDARY LDL Cholesterol |
114.1; 114.1; 101.7; 109.9; -12.4; -4.2 | 0.009 sig |
| SECONDARY HDL Cholesterol |
58.1; 58.1; 59.4; 60.3; 1.3; 2.2 | 0.730 |
| SECONDARY Triglycerides |
100.6; 100.6; 92.4; 95.6; -8.2; -5.0 | 0.487 |
Eligibility Criteria
Inclusion Criteria
- Age 18 or older
- Able to provide informed consent and comply with study visits
- Hemoglobin ≥ 10 g/dL (within last two months)
- WBC ≥ 4 K/uL (within last two months)
- Platelet count ≥ 150 ≤ 450 K/uL (within last two months)
- (GFR) Creatinine clearance ≥ 70 ml/min (MDRD) (within last two months)
- SGOT, SGPT ≤ 1.5 times upper limits of normal (within last two months)
- Normal eye exam within 12 months of study entry (copy of letter from subject's ophthalmologist or optometrist stating that the subject has no evidence of macular pathology)
- Diagnosis of rheumatoid arthritis
Exclusion Criteria
- History of any neuromuscular disease including muscular dystrophy, metabolic myopathies, peripheral neuropathy, multiple sclerosis, and other myopathies or myositides
- History of diabetes or fasting plasma glucose of 126 mg/dl or greater
- History of any untoward reaction to antimalarials
- Uncontrolled hypertension (>140/90)
- History of any ophthalmologic disease except for glaucoma or cataracts
- Planned elective surgery during the study period
- Digoxin therapy
- Treatment with corticosteroids (> 5 mg) for any disorder
- History of psoriasis
- Any chronic disease that in the opinion of the investigator warrants exclusion (e.g. inflammatory bowel disease, malignancy other than basal cell carcinoma, chronic liver disease)
- History of chronic intestinal disorders (Crohn's disease, ulcerative colitis, celiac sprue, collagenous colitis, eosinophilic enteritis)
- Creatinine clearance ≤ 60 ml/min (MDRD) (within last two months)
- Hemoglobin ≤ 10 g/dL (within last two months)
- WBC ≤ 4 K/uL (within last two months)
- Platelet count ≤ 150 ≥ 450 K/uL (within last two months)
- SGOT, SGPT ≥ 1.5 times upper limits of normal (within last two months)
- Women who are pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT01132118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.