Lack of effect of intermittently administered sodium fusidate in patients with newly diagnosed type 1 diabetes mellitus : the FUSIDM trial
We evaluated in a double-blind study the effect of early treatment with the immunomodulatory drug fusidin in patients with newly diagnosed type 1 diabetes mellitus. Twenty-eight adults with newly diagnosed type 1 diabetes were included in the study. The patients were randomly assigned (computer-gene...
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| Veröffentlicht in: | Diabetologia 2005-08, Vol.48 (8), p.1464-1468 |
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| container_title | Diabetologia |
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| creator | CONGET, I AGUILERA, E PELLITERO, S NÄF, S BENDTZEN, K CASAMITJANA, R GOMIS, R NICOLETTI, F |
| description | We evaluated in a double-blind study the effect of early treatment with the immunomodulatory drug fusidin in patients with newly diagnosed type 1 diabetes mellitus.
Twenty-eight adults with newly diagnosed type 1 diabetes were included in the study. The patients were randomly assigned (computer-generated random number sequence) to two experimental groups. Patients allocated to the fusidin (FUS) group (n=15) received sodium fusidate (fusidin; 500 mg orally three times daily for 4 weeks). Subsequently the drug was given at the same dose and scheduled for two consecutive weeks a month followed by 2 weeks a month without the drug for 20 weeks. Subjects allocated to the placebo (PCB) group (n=13) received placebo according to the same schedule and conditions described for sodium fusidate in the FUS group. All patients received a diet adjusted to their age and BMI, and intensive insulin therapy.
There were no statistically significant differences between the FUS and PCB groups in beta cell function, evaluated by basal and glucagon-stimulated C-peptide values during the follow-up (24 and 48 weeks). There was also no difference between the two groups in insulin requirement after 48 weeks (0.4+/-0.2 and 0.4+/-0.2 U/kg body weight for the FUS and PCB groups, respectively). Antibody titres, including insulin autoantibodies, were similar in the two groups during the follow-up.
Early treatment of newly diagnosed type 1 diabetes patients with intermittently administered fusidin failed to influence the natural course of the disease. |
| doi_str_mv | 10.1007/s00125-005-1823-2 |
| format | Article |
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Twenty-eight adults with newly diagnosed type 1 diabetes were included in the study. The patients were randomly assigned (computer-generated random number sequence) to two experimental groups. Patients allocated to the fusidin (FUS) group (n=15) received sodium fusidate (fusidin; 500 mg orally three times daily for 4 weeks). Subsequently the drug was given at the same dose and scheduled for two consecutive weeks a month followed by 2 weeks a month without the drug for 20 weeks. Subjects allocated to the placebo (PCB) group (n=13) received placebo according to the same schedule and conditions described for sodium fusidate in the FUS group. All patients received a diet adjusted to their age and BMI, and intensive insulin therapy.
There were no statistically significant differences between the FUS and PCB groups in beta cell function, evaluated by basal and glucagon-stimulated C-peptide values during the follow-up (24 and 48 weeks). There was also no difference between the two groups in insulin requirement after 48 weeks (0.4+/-0.2 and 0.4+/-0.2 U/kg body weight for the FUS and PCB groups, respectively). Antibody titres, including insulin autoantibodies, were similar in the two groups during the follow-up.
Early treatment of newly diagnosed type 1 diabetes patients with intermittently administered fusidin failed to influence the natural course of the disease.</description><identifier>ISSN: 0012-186X</identifier><identifier>EISSN: 1432-0428</identifier><identifier>DOI: 10.1007/s00125-005-1823-2</identifier><identifier>PMID: 15995847</identifier><language>eng</language><publisher>Berlin: Springer</publisher><subject>Adult ; Anti-Bacterial Agents - therapeutic use ; Biological and medical sciences ; C-Peptide - blood ; Diabetes Mellitus, Type 1 - drug therapy ; Diabetes Mellitus, Type 1 - physiopathology ; Diabetes. Impaired glucose tolerance ; Double-Blind Method ; Endocrine pancreas. Apud cells (diseases) ; Endocrinopathies ; Etiopathogenesis. Screening. Investigations. Target tissue resistance ; Female ; Follow-Up Studies ; Fusidic Acid - therapeutic use ; Glycated Hemoglobin A - analysis ; Glycated Hemoglobin A - metabolism ; Humans ; Hypoglycemic Agents - therapeutic use ; Immunologic Factors - therapeutic use ; Insulin - therapeutic use ; Islets of Langerhans - drug effects ; Islets of Langerhans - physiopathology ; Male ; Medical sciences</subject><ispartof>Diabetologia, 2005-08, Vol.48 (8), p.1464-1468</ispartof><rights>2005 INIST-CNRS</rights><rights>Springer-Verlag 2005</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c399t-4b5ed4113e7f044624e0809290cd22ab173e65b10f05a958919a9e5c7ebe0c9d3</citedby><cites>FETCH-LOGICAL-c399t-4b5ed4113e7f044624e0809290cd22ab173e65b10f05a958919a9e5c7ebe0c9d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,782,786,27931,27932</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17039697$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15995847$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>CONGET, I</creatorcontrib><creatorcontrib>AGUILERA, E</creatorcontrib><creatorcontrib>PELLITERO, S</creatorcontrib><creatorcontrib>NÄF, S</creatorcontrib><creatorcontrib>BENDTZEN, K</creatorcontrib><creatorcontrib>CASAMITJANA, R</creatorcontrib><creatorcontrib>GOMIS, R</creatorcontrib><creatorcontrib>NICOLETTI, F</creatorcontrib><title>Lack of effect of intermittently administered sodium fusidate in patients with newly diagnosed type 1 diabetes mellitus : the FUSIDM trial</title><title>Diabetologia</title><addtitle>Diabetologia</addtitle><description>We evaluated in a double-blind study the effect of early treatment with the immunomodulatory drug fusidin in patients with newly diagnosed type 1 diabetes mellitus.
Twenty-eight adults with newly diagnosed type 1 diabetes were included in the study. The patients were randomly assigned (computer-generated random number sequence) to two experimental groups. Patients allocated to the fusidin (FUS) group (n=15) received sodium fusidate (fusidin; 500 mg orally three times daily for 4 weeks). Subsequently the drug was given at the same dose and scheduled for two consecutive weeks a month followed by 2 weeks a month without the drug for 20 weeks. Subjects allocated to the placebo (PCB) group (n=13) received placebo according to the same schedule and conditions described for sodium fusidate in the FUS group. All patients received a diet adjusted to their age and BMI, and intensive insulin therapy.
There were no statistically significant differences between the FUS and PCB groups in beta cell function, evaluated by basal and glucagon-stimulated C-peptide values during the follow-up (24 and 48 weeks). There was also no difference between the two groups in insulin requirement after 48 weeks (0.4+/-0.2 and 0.4+/-0.2 U/kg body weight for the FUS and PCB groups, respectively). Antibody titres, including insulin autoantibodies, were similar in the two groups during the follow-up.
Early treatment of newly diagnosed type 1 diabetes patients with intermittently administered fusidin failed to influence the natural course of the disease.</description><subject>Adult</subject><subject>Anti-Bacterial Agents - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>C-Peptide - blood</subject><subject>Diabetes Mellitus, Type 1 - drug therapy</subject><subject>Diabetes Mellitus, Type 1 - physiopathology</subject><subject>Diabetes. Impaired glucose tolerance</subject><subject>Double-Blind Method</subject><subject>Endocrine pancreas. Apud cells (diseases)</subject><subject>Endocrinopathies</subject><subject>Etiopathogenesis. Screening. Investigations. Target tissue resistance</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Fusidic Acid - therapeutic use</subject><subject>Glycated Hemoglobin A - analysis</subject><subject>Glycated Hemoglobin A - metabolism</subject><subject>Humans</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>Immunologic Factors - therapeutic use</subject><subject>Insulin - therapeutic use</subject><subject>Islets of Langerhans - drug effects</subject><subject>Islets of Langerhans - physiopathology</subject><subject>Male</subject><subject>Medical sciences</subject><issn>0012-186X</issn><issn>1432-0428</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNpdkd2KFDEQhYMo7rj6AN5IEPSutfLXPfFOVlcXRrzQBe9COqm4WftnNkmzzCv41KaZgQWvEqq-c6qSQ8hLBu8YQPc-AzCuGgDVsC0XDX9ENkwK3oDk28dks7Zrp_11Rp7lfAsAQsn2KTljSmu1ld2G_N1Z94fOgWII6Mp6i1PBNMZScCrDgVo_xinmWkNP8-zjMtKw5OhtwcrSvS2xkpnex3JDJ7yvGh_t72nOVVAOe6RsLfRYMNMRhyGWJdMPtNwgvbz-cfXpGy0p2uE5eRLskPHF6Twn15eff158bXbfv1xdfNw1TmhdGtkr9JIxgV0AKVsuEbaguQbnObc96wS2qmcQQNn6Ss201ahchz2C016ck7dH332a7xbMxYwxu7qXnXBesmnrx_BqV8HX_4G385KmupvhTFRKt7pC7Ai5NOecMJh9iqNNB8PArCmZY0qmpmTWlAyvmlcn46Uf0T8oTrFU4M0JsNnZISQ7uZgfuA5End2Jf9a_mt0</recordid><startdate>20050801</startdate><enddate>20050801</enddate><creator>CONGET, I</creator><creator>AGUILERA, E</creator><creator>PELLITERO, S</creator><creator>NÄF, S</creator><creator>BENDTZEN, K</creator><creator>CASAMITJANA, R</creator><creator>GOMIS, R</creator><creator>NICOLETTI, F</creator><general>Springer</general><general>Springer Nature B.V</general><scope>IQODW</scope><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>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20050801</creationdate><title>Lack of effect of intermittently administered sodium fusidate in patients with newly diagnosed type 1 diabetes mellitus : the FUSIDM trial</title><author>CONGET, I ; AGUILERA, E ; PELLITERO, S ; NÄF, S ; BENDTZEN, K ; CASAMITJANA, R ; GOMIS, R ; NICOLETTI, F</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c399t-4b5ed4113e7f044624e0809290cd22ab173e65b10f05a958919a9e5c7ebe0c9d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Adult</topic><topic>Anti-Bacterial Agents - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>C-Peptide - blood</topic><topic>Diabetes Mellitus, Type 1 - drug therapy</topic><topic>Diabetes Mellitus, Type 1 - physiopathology</topic><topic>Diabetes. Impaired glucose tolerance</topic><topic>Double-Blind Method</topic><topic>Endocrine pancreas. Apud cells (diseases)</topic><topic>Endocrinopathies</topic><topic>Etiopathogenesis. Screening. Investigations. Target tissue resistance</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Fusidic Acid - therapeutic use</topic><topic>Glycated Hemoglobin A - analysis</topic><topic>Glycated Hemoglobin A - metabolism</topic><topic>Humans</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>Immunologic Factors - therapeutic use</topic><topic>Insulin - therapeutic use</topic><topic>Islets of Langerhans - drug effects</topic><topic>Islets of Langerhans - physiopathology</topic><topic>Male</topic><topic>Medical sciences</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>CONGET, I</creatorcontrib><creatorcontrib>AGUILERA, E</creatorcontrib><creatorcontrib>PELLITERO, S</creatorcontrib><creatorcontrib>NÄF, S</creatorcontrib><creatorcontrib>BENDTZEN, K</creatorcontrib><creatorcontrib>CASAMITJANA, R</creatorcontrib><creatorcontrib>GOMIS, R</creatorcontrib><creatorcontrib>NICOLETTI, F</creatorcontrib><collection>Pascal-Francis</collection><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>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Diabetologia</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>CONGET, I</au><au>AGUILERA, E</au><au>PELLITERO, S</au><au>NÄF, S</au><au>BENDTZEN, K</au><au>CASAMITJANA, R</au><au>GOMIS, R</au><au>NICOLETTI, F</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Lack of effect of intermittently administered sodium fusidate in patients with newly diagnosed type 1 diabetes mellitus : the FUSIDM trial</atitle><jtitle>Diabetologia</jtitle><addtitle>Diabetologia</addtitle><date>2005-08-01</date><risdate>2005</risdate><volume>48</volume><issue>8</issue><spage>1464</spage><epage>1468</epage><pages>1464-1468</pages><issn>0012-186X</issn><eissn>1432-0428</eissn><abstract>We evaluated in a double-blind study the effect of early treatment with the immunomodulatory drug fusidin in patients with newly diagnosed type 1 diabetes mellitus.
Twenty-eight adults with newly diagnosed type 1 diabetes were included in the study. The patients were randomly assigned (computer-generated random number sequence) to two experimental groups. Patients allocated to the fusidin (FUS) group (n=15) received sodium fusidate (fusidin; 500 mg orally three times daily for 4 weeks). Subsequently the drug was given at the same dose and scheduled for two consecutive weeks a month followed by 2 weeks a month without the drug for 20 weeks. Subjects allocated to the placebo (PCB) group (n=13) received placebo according to the same schedule and conditions described for sodium fusidate in the FUS group. All patients received a diet adjusted to their age and BMI, and intensive insulin therapy.
There were no statistically significant differences between the FUS and PCB groups in beta cell function, evaluated by basal and glucagon-stimulated C-peptide values during the follow-up (24 and 48 weeks). There was also no difference between the two groups in insulin requirement after 48 weeks (0.4+/-0.2 and 0.4+/-0.2 U/kg body weight for the FUS and PCB groups, respectively). Antibody titres, including insulin autoantibodies, were similar in the two groups during the follow-up.
Early treatment of newly diagnosed type 1 diabetes patients with intermittently administered fusidin failed to influence the natural course of the disease.</abstract><cop>Berlin</cop><pub>Springer</pub><pmid>15995847</pmid><doi>10.1007/s00125-005-1823-2</doi><tpages>5</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Anti-Bacterial Agents - therapeutic use Biological and medical sciences C-Peptide - blood Diabetes Mellitus, Type 1 - drug therapy Diabetes Mellitus, Type 1 - physiopathology Diabetes. Impaired glucose tolerance Double-Blind Method Endocrine pancreas. Apud cells (diseases) Endocrinopathies Etiopathogenesis. Screening. Investigations. Target tissue resistance Female Follow-Up Studies Fusidic Acid - therapeutic use Glycated Hemoglobin A - analysis Glycated Hemoglobin A - metabolism Humans Hypoglycemic Agents - therapeutic use Immunologic Factors - therapeutic use Insulin - therapeutic use Islets of Langerhans - drug effects Islets of Langerhans - physiopathology Male Medical sciences |
| title | Lack of effect of intermittently administered sodium fusidate in patients with newly diagnosed type 1 diabetes mellitus : the FUSIDM trial |
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