Study Results
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View full resultsBasic Information
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TERMINATED
NA
21 participants
INTERVENTIONAL
2012-03-31
2022-12-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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hydroxychloroquine
hydroxychloroquine twice daily for 4 weeks
Hydroxychloroquine
200mg twice daily
Placebo
hydroxychloroquine placebo twice daily for 4 weeks
Hydroxychloroquine Placebo
200mg placebo twice daily
Interventions
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Hydroxychloroquine
200mg twice daily
Hydroxychloroquine Placebo
200mg placebo twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must have type 2 diabetes and the following:
* A1c of 6.5-9.0%
* Treated with at least 1000 mg of metformin daily with or without a dipeptidyl peptidase-4(DPP4)inhibitor, a sulfonylurea (glipizide, glyburide, glimepiride),bromocriptine or colesevelam.
* Subjects should have a BMI \>27
Exclusion Criteria
1. any exposure in the past 2 years,
2. \>30 days of therapy if exposure was between 2 and 5 years ago,
3. \>90 days of therapy if exposure was between 5 and 10 years ago,
4. \>6 months of therapy if exposure was 10 to 20 years ago,
5. \>1 year of therapy if exposure was 20 to 30 years ago,
6. No limit if last exposure was \>30 years ago, e.g. during the Vietnam conflict.
* Morbid obesity (BMI \>45)
* Coronary artery disease or other vascular disease
* History of stroke
* Serum creatinine \>-4 mg/dl for women and \>-5 mg/dl for men.
* Seizure disorder
* History of psoriasis
* Hematologic disorders, including anemia (WHO criteria for anemia:hemoglobin \<13g/dL in men and \<12 g/dL in women)
* Current malignancy or active treatment for recurrence prevention,e.g. tamoxifen. Cancer considered to be cured, either as a result of surgery or other treatment is not exclusionary.
* Asthma requiring daily beta agonist therapy or intermittent oral steroids is exclusionary. Inhaled steroids are acceptable. Obstructive sleep apnea will be allowed if continuous positive airway pressure(CPAP) or other therapy has been stable for 6 months. Other active respiratory diseases are excluded.
* Treatment with 50mg or greater of Metoprolol or treatment with digoxin
* Liver disease, or Liver Function Test \>2 times normal
* Active infection (including HIV)
* Serious illness requiring ongoing medical care or medication
* Treatment with atypical anti-psychotic medication. Treatment with any other medication for psychiatric illness, unless on a stable dose for 6 weeks prior to enrollment. Patients with unstable psychiatric disorders are excluded per the decision of the study MD regardless of medication history.
* Taking any of the following lipid lowering medications: niacin, fibrates, and greater than 1 gm/day of fish oils
* Uncontrolled hypertension (BP \>150/90 mm Hg) at enrollment
* Need for daily Over The Counter medications, or currently taking cimetidine or \>1000 IU vitamin E daily and unwilling to reduce or discontinue vitamin E or discontinue cimetidine for the duration of the study. Patients taking more than 1000 IU vitamin E daily should reduce or discontinue the vitamin for 30 days before randomization.
* Pregnant or lactating women, or women intending to become pregnant
* Women not using adequate birth control (hormonal birth control is acceptable, also double barrier)
* QT corrected \>450 msec on screening ECG
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency
18 Years
75 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Clay F. Semenkovich, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University
St Louis, Missouri, United States
Countries
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References
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Rao Kondapally Seshasai S, Kaptoge S, Thompson A, Di Angelantonio E, Gao P, Sarwar N, Whincup PH, Mukamal KJ, Gillum RF, Holme I, Njolstad I, Fletcher A, Nilsson P, Lewington S, Collins R, Gudnason V, Thompson SG, Sattar N, Selvin E, Hu FB, Danesh J; Emerging Risk Factors Collaboration. Diabetes mellitus, fasting glucose, and risk of cause-specific death. N Engl J Med. 2011 Mar 3;364(9):829-841. doi: 10.1056/NEJMoa1008862.
Schramm TK, Gislason GH, Kober L, Rasmussen S, Rasmussen JN, Abildstrom SZ, Hansen ML, Folke F, Buch P, Madsen M, Vaag A, Torp-Pedersen C. Diabetes patients requiring glucose-lowering therapy and nondiabetics with a prior myocardial infarction carry the same cardiovascular risk: a population study of 3.3 million people. Circulation. 2008 Apr 15;117(15):1945-54. doi: 10.1161/CIRCULATIONAHA.107.720847. Epub 2008 Mar 31.
Schneider JG, Finck BN, Ren J, Standley KN, Takagi M, Maclean KH, Bernal-Mizrachi C, Muslin AJ, Kastan MB, Semenkovich CF. ATM-dependent suppression of stress signaling reduces vascular disease in metabolic syndrome. Cell Metab. 2006 Nov;4(5):377-89. doi: 10.1016/j.cmet.2006.10.002.
Marmor MF, Kellner U, Lai TY, Lyons JS, Mieler WF; American Academy of Ophthalmology. Revised recommendations on screening for chloroquine and hydroxychloroquine retinopathy. Ophthalmology. 2011 Feb;118(2):415-22. doi: 10.1016/j.ophtha.2010.11.017.
Su Y, Swift M. Mortality rates among carriers of ataxia-telangiectasia mutant alleles. Ann Intern Med. 2000 Nov 21;133(10):770-8. doi: 10.7326/0003-4819-133-10-200011210-00009.
Razani B, Feng C, Semenkovich CF. p53 is required for chloroquine-induced atheroprotection but not insulin sensitization. J Lipid Res. 2010 Jul;51(7):1738-46. doi: 10.1194/jlr.M003681. Epub 2010 Mar 5.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Washington University Research Patient Registry
Clay F. Semenkovich, M.D.
Other Identifiers
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201110258
Identifier Type: OTHER
Identifier Source: secondary_id
201110258
Identifier Type: -
Identifier Source: org_study_id