Study Stopped
COVID-19 \& loss of funding
Metabolic Effects of Hydroxychloroquine
MetaHcQ
1 other identifier
interventional
21
1 country
1
Brief Summary
The basic plan of the study is to randomize otherwise healthy subjects with type 2 diabetes to hydroxychloroquine, 200 mg twice daily or placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes-mellitus
Started Mar 2012
Longer than P75 for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 24, 2013
CompletedFirst Posted
Study publicly available on registry
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2022
CompletedResults Posted
Study results publicly available
December 28, 2023
CompletedDecember 28, 2023
December 1, 2023
10.8 years
December 24, 2013
December 8, 2023
December 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of HCQ on Fasting Blood Glucose
determined by fasting blood glucose performed at baseline and follow-up
4 weeks
Secondary Outcomes (1)
Effect of HCQ on Fasting Low Density Lipoprotein
4 weeks
Study Arms (2)
hydroxychloroquine
ACTIVE COMPARATORhydroxychloroquine twice daily for 4 weeks
Placebo
PLACEBO COMPARATORhydroxychloroquine placebo twice daily for 4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Subjects between the age of 18 and 75, either gender, any ethnic group
- 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
You may not qualify if:
- Prior treatment with chloroquine or hydroxychloroquine as follows:
- any exposure in the past 2 years,
- \>30 days of therapy if exposure was between 2 and 5 years ago,
- \>90 days of therapy if exposure was between 5 and 10 years ago,
- \>6 months of therapy if exposure was 10 to 20 years ago,
- \>1 year of therapy if exposure was 20 to 30 years ago,
- 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)
- Treatment with 50mg or greater of Metoprolol or treatment with digoxin
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University
St Louis, Missouri, 63110, United States
Related Publications (6)
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.
PMID: 21366474BACKGROUNDSchramm 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.
PMID: 18378618BACKGROUNDSchneider 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.
PMID: 17084711BACKGROUNDMarmor 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.
PMID: 21292109BACKGROUNDSu 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.
PMID: 11085839BACKGROUNDRazani 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.
PMID: 20208057BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Janet McGill
- Organization
- Washington University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Clay F. Semenkovich, M.D.
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 24, 2013
First Posted
January 1, 2014
Study Start
March 1, 2012
Primary Completion
December 15, 2022
Study Completion
December 15, 2022
Last Updated
December 28, 2023
Results First Posted
December 28, 2023
Record last verified: 2023-12