Antidiabetogenic effects of hydroxychloroquine on insulin sensitivity and beta cell function: a randomised trial
Aims/hypothesis Hydroxychloroquine (HCQ), an antimalarial drug with anti-inflammatory properties, is employed in rheumatic diseases. In observational studies, patients with rheumatic diseases treated with HCQ have a lower risk of developing diabetes. However, the physiological mechanisms remain unex...
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| Veröffentlicht in: | Diabetologia 2015-10, Vol.58 (10), p.2336-2343 |
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| creator | Wasko, Mary Chester M. McClure, Candace K. Kelsey, Sheryl F. Huber, Kimberly Orchard, Trevor Toledo, Frederico G. S. |
| description | Aims/hypothesis
Hydroxychloroquine (HCQ), an antimalarial drug with anti-inflammatory properties, is employed in rheumatic diseases. In observational studies, patients with rheumatic diseases treated with HCQ have a lower risk of developing diabetes. However, the physiological mechanisms remain unexplained. We hypothesised that HCQ may have favourable effects on insulin sensitivity and/or beta cell function.
Methods
This was a randomised, double-blind, parallel-arm (placebo vs HCQ 400 mg/day) trial at the University of Pittsburgh. Randomisation was conducted by a computer system with concealment by sealed envelopes. Treatment duration was 13 ± 1 weeks. Randomised participants (HCQ
n
= 17; placebo
n
= 15) were non-diabetic volunteers, age >18, overweight or obese, with one or more markers of insulin resistance. All participants were included in intention-to-treat analysis. Outcomes were changes in insulin sensitivity and beta cell function measured by intravenous glucose tolerance tests and minimal model analysis.
Results
There was a positive change in insulin sensitivity with HCQ but not placebo (mean ± SEM: +20.0% ± 7.1% vs −18.4% ± 7.9%, respectively;
p
|
| doi_str_mv | 10.1007/s00125-015-3689-2 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4575248</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3808852301</sourcerecordid><originalsourceid>FETCH-LOGICAL-c540t-bdd09adf12bfb600cb8df59e36e3c291dba49e35b3169f852096db764dbb48603</originalsourceid><addsrcrecordid>eNp1kUuLFDEUhYMoTjv6A9xIwI2b0ptUkqpyIQyDLxhwo-Au5NmdoTppk9Qw_e9N0eMwCq4u4Xz33BwOQi8JvCUAw7sCQCjvgPCuF-PU0UdoQ1hPO2B0fIw2q9yRUfw8Q89KuQaAnjPxFJ1RQaZhgGGDDhexBhuUdjVtXQwGO--dqQUnj3dHm9Pt0ezmlNOvJUSHU8QhlmUOERcXS6jhJtQjVtHiZqGwcfOM_RJNDSm-xwrnJqV9KM7imoOan6MnXs3Fvbib5-jHp4_fL790V98-f728uOoMZ1A7bS1MynpCtdcCwOjRej65Xrje0IlYrVh7cd0TMfmRU5iE1YNgVms2CujP0YeT72HRe2eNizWrWR5y2Kt8lEkF-bcSw05u041kfOCUjc3gzZ3Bmt2VKluKNZ6KLi1FkoH0EydA-4a-_ge9TkuOLd5K0YGyiYlGkRNlciolO3__GQJy7VOe-pStT7n2KWnbefUwxf3GnwIbQE9AaVLcuvzg9H9dfwPkzq6D</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1712724946</pqid></control><display><type>article</type><title>Antidiabetogenic effects of hydroxychloroquine on insulin sensitivity and beta cell function: a randomised trial</title><source>MEDLINE</source><source>SpringerLink Journals</source><creator>Wasko, Mary Chester M. ; McClure, Candace K. ; Kelsey, Sheryl F. ; Huber, Kimberly ; Orchard, Trevor ; Toledo, Frederico G. S.</creator><creatorcontrib>Wasko, Mary Chester M. ; McClure, Candace K. ; Kelsey, Sheryl F. ; Huber, Kimberly ; Orchard, Trevor ; Toledo, Frederico G. S.</creatorcontrib><description>Aims/hypothesis
Hydroxychloroquine (HCQ), an antimalarial drug with anti-inflammatory properties, is employed in rheumatic diseases. In observational studies, patients with rheumatic diseases treated with HCQ have a lower risk of developing diabetes. However, the physiological mechanisms remain unexplained. We hypothesised that HCQ may have favourable effects on insulin sensitivity and/or beta cell function.
Methods
This was a randomised, double-blind, parallel-arm (placebo vs HCQ 400 mg/day) trial at the University of Pittsburgh. Randomisation was conducted by a computer system with concealment by sealed envelopes. Treatment duration was 13 ± 1 weeks. Randomised participants (HCQ
n
= 17; placebo
n
= 15) were non-diabetic volunteers, age >18, overweight or obese, with one or more markers of insulin resistance. All participants were included in intention-to-treat analysis. Outcomes were changes in insulin sensitivity and beta cell function measured by intravenous glucose tolerance tests and minimal model analysis.
Results
There was a positive change in insulin sensitivity with HCQ but not placebo (mean ± SEM: +20.0% ± 7.1% vs −18.4% ± 7.9%, respectively;
p
< 0.01; difference: 38.3% ± 10.6%; 95% CI: 17%, 60%). Improvement in beta cell function was also observed with HCQ but not placebo (+45.4% ± 12.3% vs −19.7% ± 13.6%;
p
< 0.01; difference: 65% ± 19%; 95% CI: 27%, 103%). There were modest treatment effects on fasting plasma glucose and HbA
1c
(
p
< 0.05) but circulating markers of inflammation (IL-6, IL-1, TNF-α, soluble intercellular adhesion molecule) were not affected in either group. In contrast, adiponectin levels increased after HCQ treatment but not after placebo (+18.7% vs +0.7%, respectively;
p
< 0.001). Both low- and high-molecular-weight adiponectin forms accounted for the increase. There were no serious or unexpected adverse effects.
Conclusions/interpretation
HCQ improves both beta cell function and insulin sensitivity in non-diabetic individuals. These metabolic effects may explain why HCQ treatment is associated with a lower risk of type 2 diabetes. An additional novel observation is that HCQ improves adiponectin levels, possibly being a mediator of the favourable effects on glucose metabolism. Our findings suggest that HCQ is a drug with considerable metabolic effects that warrant further exploration in disorders of glucose metabolism.
Trial registration
Clinicaltrials.gov NCT01326533
Funding
This study was funded by National Institutes of Health no. 5R21DK082878, UL1-RR024153 and UL-1TR000005.</description><identifier>ISSN: 0012-186X</identifier><identifier>EISSN: 1432-0428</identifier><identifier>DOI: 10.1007/s00125-015-3689-2</identifier><identifier>PMID: 26197707</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Adult ; Antiparasitic agents ; Blood Glucose - metabolism ; Cytokines - blood ; Diabetes ; Disease prevention ; Double-Blind Method ; Female ; Glucose ; Human Physiology ; Humans ; Hydroxychloroquine - pharmacology ; Insulin - blood ; Insulin resistance ; Insulin Resistance - physiology ; Insulin-Secreting Cells - drug effects ; Insulin-Secreting Cells - metabolism ; Intercellular Adhesion Molecule-1 - blood ; Internal Medicine ; Malaria ; Male ; Medicine ; Medicine & Public Health ; Metabolic Diseases ; Metabolism ; Middle Aged ; Obesity - blood ; Obesity - metabolism ; Observational studies ; Overweight - blood ; Overweight - metabolism ; Public health ; Rheumatic diseases ; Treatment Outcome</subject><ispartof>Diabetologia, 2015-10, Vol.58 (10), p.2336-2343</ispartof><rights>Springer-Verlag Berlin Heidelberg 2015</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c540t-bdd09adf12bfb600cb8df59e36e3c291dba49e35b3169f852096db764dbb48603</citedby><cites>FETCH-LOGICAL-c540t-bdd09adf12bfb600cb8df59e36e3c291dba49e35b3169f852096db764dbb48603</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00125-015-3689-2$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00125-015-3689-2$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>230,314,776,780,881,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26197707$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Wasko, Mary Chester M.</creatorcontrib><creatorcontrib>McClure, Candace K.</creatorcontrib><creatorcontrib>Kelsey, Sheryl F.</creatorcontrib><creatorcontrib>Huber, Kimberly</creatorcontrib><creatorcontrib>Orchard, Trevor</creatorcontrib><creatorcontrib>Toledo, Frederico G. S.</creatorcontrib><title>Antidiabetogenic effects of hydroxychloroquine on insulin sensitivity and beta cell function: a randomised trial</title><title>Diabetologia</title><addtitle>Diabetologia</addtitle><addtitle>Diabetologia</addtitle><description>Aims/hypothesis
Hydroxychloroquine (HCQ), an antimalarial drug with anti-inflammatory properties, is employed in rheumatic diseases. In observational studies, patients with rheumatic diseases treated with HCQ have a lower risk of developing diabetes. However, the physiological mechanisms remain unexplained. We hypothesised that HCQ may have favourable effects on insulin sensitivity and/or beta cell function.
Methods
This was a randomised, double-blind, parallel-arm (placebo vs HCQ 400 mg/day) trial at the University of Pittsburgh. Randomisation was conducted by a computer system with concealment by sealed envelopes. Treatment duration was 13 ± 1 weeks. Randomised participants (HCQ
n
= 17; placebo
n
= 15) were non-diabetic volunteers, age >18, overweight or obese, with one or more markers of insulin resistance. All participants were included in intention-to-treat analysis. Outcomes were changes in insulin sensitivity and beta cell function measured by intravenous glucose tolerance tests and minimal model analysis.
Results
There was a positive change in insulin sensitivity with HCQ but not placebo (mean ± SEM: +20.0% ± 7.1% vs −18.4% ± 7.9%, respectively;
p
< 0.01; difference: 38.3% ± 10.6%; 95% CI: 17%, 60%). Improvement in beta cell function was also observed with HCQ but not placebo (+45.4% ± 12.3% vs −19.7% ± 13.6%;
p
< 0.01; difference: 65% ± 19%; 95% CI: 27%, 103%). There were modest treatment effects on fasting plasma glucose and HbA
1c
(
p
< 0.05) but circulating markers of inflammation (IL-6, IL-1, TNF-α, soluble intercellular adhesion molecule) were not affected in either group. In contrast, adiponectin levels increased after HCQ treatment but not after placebo (+18.7% vs +0.7%, respectively;
p
< 0.001). Both low- and high-molecular-weight adiponectin forms accounted for the increase. There were no serious or unexpected adverse effects.
Conclusions/interpretation
HCQ improves both beta cell function and insulin sensitivity in non-diabetic individuals. These metabolic effects may explain why HCQ treatment is associated with a lower risk of type 2 diabetes. An additional novel observation is that HCQ improves adiponectin levels, possibly being a mediator of the favourable effects on glucose metabolism. Our findings suggest that HCQ is a drug with considerable metabolic effects that warrant further exploration in disorders of glucose metabolism.
Trial registration
Clinicaltrials.gov NCT01326533
Funding
This study was funded by National Institutes of Health no. 5R21DK082878, UL1-RR024153 and UL-1TR000005.</description><subject>Adult</subject><subject>Antiparasitic agents</subject><subject>Blood Glucose - metabolism</subject><subject>Cytokines - blood</subject><subject>Diabetes</subject><subject>Disease prevention</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Glucose</subject><subject>Human Physiology</subject><subject>Humans</subject><subject>Hydroxychloroquine - pharmacology</subject><subject>Insulin - blood</subject><subject>Insulin resistance</subject><subject>Insulin Resistance - physiology</subject><subject>Insulin-Secreting Cells - drug effects</subject><subject>Insulin-Secreting Cells - metabolism</subject><subject>Intercellular Adhesion Molecule-1 - blood</subject><subject>Internal Medicine</subject><subject>Malaria</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Metabolic Diseases</subject><subject>Metabolism</subject><subject>Middle Aged</subject><subject>Obesity - blood</subject><subject>Obesity - metabolism</subject><subject>Observational studies</subject><subject>Overweight - blood</subject><subject>Overweight - metabolism</subject><subject>Public health</subject><subject>Rheumatic diseases</subject><subject>Treatment Outcome</subject><issn>0012-186X</issn><issn>1432-0428</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp1kUuLFDEUhYMoTjv6A9xIwI2b0ptUkqpyIQyDLxhwo-Au5NmdoTppk9Qw_e9N0eMwCq4u4Xz33BwOQi8JvCUAw7sCQCjvgPCuF-PU0UdoQ1hPO2B0fIw2q9yRUfw8Q89KuQaAnjPxFJ1RQaZhgGGDDhexBhuUdjVtXQwGO--dqQUnj3dHm9Pt0ezmlNOvJUSHU8QhlmUOERcXS6jhJtQjVtHiZqGwcfOM_RJNDSm-xwrnJqV9KM7imoOan6MnXs3Fvbib5-jHp4_fL790V98-f728uOoMZ1A7bS1MynpCtdcCwOjRej65Xrje0IlYrVh7cd0TMfmRU5iE1YNgVms2CujP0YeT72HRe2eNizWrWR5y2Kt8lEkF-bcSw05u041kfOCUjc3gzZ3Bmt2VKluKNZ6KLi1FkoH0EydA-4a-_ge9TkuOLd5K0YGyiYlGkRNlciolO3__GQJy7VOe-pStT7n2KWnbefUwxf3GnwIbQE9AaVLcuvzg9H9dfwPkzq6D</recordid><startdate>20151001</startdate><enddate>20151001</enddate><creator>Wasko, Mary Chester M.</creator><creator>McClure, Candace K.</creator><creator>Kelsey, Sheryl F.</creator><creator>Huber, Kimberly</creator><creator>Orchard, Trevor</creator><creator>Toledo, Frederico G. S.</creator><general>Springer Berlin Heidelberg</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7T5</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20151001</creationdate><title>Antidiabetogenic effects of hydroxychloroquine on insulin sensitivity and beta cell function: a randomised trial</title><author>Wasko, Mary Chester M. ; McClure, Candace K. ; Kelsey, Sheryl F. ; Huber, Kimberly ; Orchard, Trevor ; Toledo, Frederico G. S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c540t-bdd09adf12bfb600cb8df59e36e3c291dba49e35b3169f852096db764dbb48603</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adult</topic><topic>Antiparasitic agents</topic><topic>Blood Glucose - metabolism</topic><topic>Cytokines - blood</topic><topic>Diabetes</topic><topic>Disease prevention</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Glucose</topic><topic>Human Physiology</topic><topic>Humans</topic><topic>Hydroxychloroquine - pharmacology</topic><topic>Insulin - blood</topic><topic>Insulin resistance</topic><topic>Insulin Resistance - physiology</topic><topic>Insulin-Secreting Cells - drug effects</topic><topic>Insulin-Secreting Cells - metabolism</topic><topic>Intercellular Adhesion Molecule-1 - blood</topic><topic>Internal Medicine</topic><topic>Malaria</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Metabolic Diseases</topic><topic>Metabolism</topic><topic>Middle Aged</topic><topic>Obesity - blood</topic><topic>Obesity - metabolism</topic><topic>Observational studies</topic><topic>Overweight - blood</topic><topic>Overweight - metabolism</topic><topic>Public health</topic><topic>Rheumatic diseases</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Wasko, Mary Chester M.</creatorcontrib><creatorcontrib>McClure, Candace K.</creatorcontrib><creatorcontrib>Kelsey, Sheryl F.</creatorcontrib><creatorcontrib>Huber, Kimberly</creatorcontrib><creatorcontrib>Orchard, Trevor</creatorcontrib><creatorcontrib>Toledo, Frederico G. S.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Immunology Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Diabetologia</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Wasko, Mary Chester M.</au><au>McClure, Candace K.</au><au>Kelsey, Sheryl F.</au><au>Huber, Kimberly</au><au>Orchard, Trevor</au><au>Toledo, Frederico G. S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Antidiabetogenic effects of hydroxychloroquine on insulin sensitivity and beta cell function: a randomised trial</atitle><jtitle>Diabetologia</jtitle><stitle>Diabetologia</stitle><addtitle>Diabetologia</addtitle><date>2015-10-01</date><risdate>2015</risdate><volume>58</volume><issue>10</issue><spage>2336</spage><epage>2343</epage><pages>2336-2343</pages><issn>0012-186X</issn><eissn>1432-0428</eissn><abstract>Aims/hypothesis
Hydroxychloroquine (HCQ), an antimalarial drug with anti-inflammatory properties, is employed in rheumatic diseases. In observational studies, patients with rheumatic diseases treated with HCQ have a lower risk of developing diabetes. However, the physiological mechanisms remain unexplained. We hypothesised that HCQ may have favourable effects on insulin sensitivity and/or beta cell function.
Methods
This was a randomised, double-blind, parallel-arm (placebo vs HCQ 400 mg/day) trial at the University of Pittsburgh. Randomisation was conducted by a computer system with concealment by sealed envelopes. Treatment duration was 13 ± 1 weeks. Randomised participants (HCQ
n
= 17; placebo
n
= 15) were non-diabetic volunteers, age >18, overweight or obese, with one or more markers of insulin resistance. All participants were included in intention-to-treat analysis. Outcomes were changes in insulin sensitivity and beta cell function measured by intravenous glucose tolerance tests and minimal model analysis.
Results
There was a positive change in insulin sensitivity with HCQ but not placebo (mean ± SEM: +20.0% ± 7.1% vs −18.4% ± 7.9%, respectively;
p
< 0.01; difference: 38.3% ± 10.6%; 95% CI: 17%, 60%). Improvement in beta cell function was also observed with HCQ but not placebo (+45.4% ± 12.3% vs −19.7% ± 13.6%;
p
< 0.01; difference: 65% ± 19%; 95% CI: 27%, 103%). There were modest treatment effects on fasting plasma glucose and HbA
1c
(
p
< 0.05) but circulating markers of inflammation (IL-6, IL-1, TNF-α, soluble intercellular adhesion molecule) were not affected in either group. In contrast, adiponectin levels increased after HCQ treatment but not after placebo (+18.7% vs +0.7%, respectively;
p
< 0.001). Both low- and high-molecular-weight adiponectin forms accounted for the increase. There were no serious or unexpected adverse effects.
Conclusions/interpretation
HCQ improves both beta cell function and insulin sensitivity in non-diabetic individuals. These metabolic effects may explain why HCQ treatment is associated with a lower risk of type 2 diabetes. An additional novel observation is that HCQ improves adiponectin levels, possibly being a mediator of the favourable effects on glucose metabolism. Our findings suggest that HCQ is a drug with considerable metabolic effects that warrant further exploration in disorders of glucose metabolism.
Trial registration
Clinicaltrials.gov NCT01326533
Funding
This study was funded by National Institutes of Health no. 5R21DK082878, UL1-RR024153 and UL-1TR000005.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>26197707</pmid><doi>10.1007/s00125-015-3689-2</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Diabetologia, 2015-10, Vol.58 (10), p.2336-2343 |
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| source | MEDLINE; SpringerLink Journals |
| subjects | Adult Antiparasitic agents Blood Glucose - metabolism Cytokines - blood Diabetes Disease prevention Double-Blind Method Female Glucose Human Physiology Humans Hydroxychloroquine - pharmacology Insulin - blood Insulin resistance Insulin Resistance - physiology Insulin-Secreting Cells - drug effects Insulin-Secreting Cells - metabolism Intercellular Adhesion Molecule-1 - blood Internal Medicine Malaria Male Medicine Medicine & Public Health Metabolic Diseases Metabolism Middle Aged Obesity - blood Obesity - metabolism Observational studies Overweight - blood Overweight - metabolism Public health Rheumatic diseases Treatment Outcome |
| title | Antidiabetogenic effects of hydroxychloroquine on insulin sensitivity and beta cell function: a randomised trial |
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