Effects of Oral Insulin in Relatives of Patients With Type 1 Diabetes: The Diabetes Prevention Trial-Type 1

OBJECTIVE:--This randomized, double-masked, placebo-controlled clinical trial tested whether oral insulin administration could delay or prevent type 1 diabetes in nondiabetic relatives at risk for diabetes. RESEARCH DESIGN AND METHODS--We screened 103,391 first- and second-degree relatives of patien...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:Diabetes care 2005-05, Vol.28 (5), p.1068-1076
Hauptverfasser: Skyler, Jay S, Krischer, Jeffrey P, Wolfsdorf, Joseph, Cowie, Catherine, Palmer, Jerry P, Greenbaum, Carla, Cuthbertson, David, Rafkin-Mervis, Lisa E, Chase, H Peter, Leschek, Ellen
Format: Artikel
Sprache:eng
Schlagworte:
Online-Zugang:Volltext
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
container_end_page 1076
container_issue 5
container_start_page 1068
container_title Diabetes care
container_volume 28
creator Skyler, Jay S
Krischer, Jeffrey P
Wolfsdorf, Joseph
Cowie, Catherine
Palmer, Jerry P
Greenbaum, Carla
Cuthbertson, David
Rafkin-Mervis, Lisa E
Chase, H Peter
Leschek, Ellen
description OBJECTIVE:--This randomized, double-masked, placebo-controlled clinical trial tested whether oral insulin administration could delay or prevent type 1 diabetes in nondiabetic relatives at risk for diabetes. RESEARCH DESIGN AND METHODS--We screened 103,391 first- and second-degree relatives of patients with type 1 diabetes and analyzed 97,273 samples for islet cell antibodies. A total of 3,483 were antibody positive; 2,523 underwent genetic, immunological, and metabolic staging to quantify risk of developing diabetes; 388 had a 5-year risk projection of 26-50%; and 372 (median age 10.25 years) were randomly assigned to oral insulin (7.5 mg/day) or placebo. Oral glucose tolerance tests were performed every 6 months. The median follow-up was 4.3 years, and the primary end point was diagnosis of diabetes. RESULTS:--Diabetes was diagnosed in 44 oral insulin and 53 placebo subjects. Annualized rate of diabetes was similar in both groups: 6.4% with oral insulin and 8.2% with placebo (hazard ratio 0.764, P = 0.189). In a hypothesis-generating analysis of a subgroup with insulin autoantibody (IAA) levels confirmed (on two occasions) [>/=]80 nU/ml (n = 263), there was the suggestion of benefit: annualized diabetes rate 6.2% with oral insulin and 10.4% with placebo (0.566, P = 0.015). CONCLUSIONS:--It is possible to identify individuals at high risk for type 1 diabetes and to enroll them in a large, multisite, randomized, controlled clinical trial. However, oral insulin did not delay or prevent type 1 diabetes. Further studies are needed to explore the potential role of oral insulin in delaying diabetes in relatives similar to those in the subgroup with higher IAA levels.
doi_str_mv 10.2337/diacare.28.5.1068
format Article
fullrecord <record><control><sourceid>gale_proqu</sourceid><recordid>TN_cdi_proquest_miscellaneous_67787321</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A132419463</galeid><sourcerecordid>A132419463</sourcerecordid><originalsourceid>FETCH-LOGICAL-f367t-53c4a5b597138b7ed3ddef66b5a36b545183bd1d062640c190eadd63a9816a8d3</originalsourceid><addsrcrecordid>eNpt0V1rFDEUBuAgil2rP8AbHQS9mzHfk3hXatVCoUW3eDmcmZxsU2czazJT6L83uKuClIR8PgkvCSEvGW24EO17F2CAhA03jWoY1eYRWTErVK2UNI_JijJpa2UtPyLPcr6llEppzFNyxJRRSmm7Ij_OvMdhztXkq8sEY3Ue8zKGWJX6FUeYwx3-3rwqQ4wFfg_zTbW-32HFqo8Bepwxf6jWN_h3Vl0lvCs2TLFapwBjvefPyRMPY8YXh_6YXH86W59-qS8uP5-fnlzUXuh2rpUYJKhe2ZYJ07fohHPote4ViNJIxYzoHXNUcy3pwCxFcE4LsIZpME4ck3f7e3dp-rlgnrttyAOOI0ScltzptjWt4KzAN__B22lJsWTrOBdUtEbZguo92sCIXYh-mhMMG4xYnmuK6ENZPmGCS2alFsU3D_hSHG7D8OCBV4cUS79F1-1S2EK67_58UgFvDwDyAKNPEIeQ_zndclnSFvd67zxMHWxSMdffOGWCUmusbLn4BWQ5qHE</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>223037859</pqid></control><display><type>article</type><title>Effects of Oral Insulin in Relatives of Patients With Type 1 Diabetes: The Diabetes Prevention Trial-Type 1</title><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><creator>Skyler, Jay S ; Krischer, Jeffrey P ; Wolfsdorf, Joseph ; Cowie, Catherine ; Palmer, Jerry P ; Greenbaum, Carla ; Cuthbertson, David ; Rafkin-Mervis, Lisa E ; Chase, H Peter ; Leschek, Ellen</creator><creatorcontrib>Skyler, Jay S ; Krischer, Jeffrey P ; Wolfsdorf, Joseph ; Cowie, Catherine ; Palmer, Jerry P ; Greenbaum, Carla ; Cuthbertson, David ; Rafkin-Mervis, Lisa E ; Chase, H Peter ; Leschek, Ellen</creatorcontrib><description>OBJECTIVE:--This randomized, double-masked, placebo-controlled clinical trial tested whether oral insulin administration could delay or prevent type 1 diabetes in nondiabetic relatives at risk for diabetes. RESEARCH DESIGN AND METHODS--We screened 103,391 first- and second-degree relatives of patients with type 1 diabetes and analyzed 97,273 samples for islet cell antibodies. A total of 3,483 were antibody positive; 2,523 underwent genetic, immunological, and metabolic staging to quantify risk of developing diabetes; 388 had a 5-year risk projection of 26-50%; and 372 (median age 10.25 years) were randomly assigned to oral insulin (7.5 mg/day) or placebo. Oral glucose tolerance tests were performed every 6 months. The median follow-up was 4.3 years, and the primary end point was diagnosis of diabetes. RESULTS:--Diabetes was diagnosed in 44 oral insulin and 53 placebo subjects. Annualized rate of diabetes was similar in both groups: 6.4% with oral insulin and 8.2% with placebo (hazard ratio 0.764, P = 0.189). In a hypothesis-generating analysis of a subgroup with insulin autoantibody (IAA) levels confirmed (on two occasions) [&gt;/=]80 nU/ml (n = 263), there was the suggestion of benefit: annualized diabetes rate 6.2% with oral insulin and 10.4% with placebo (0.566, P = 0.015). CONCLUSIONS:--It is possible to identify individuals at high risk for type 1 diabetes and to enroll them in a large, multisite, randomized, controlled clinical trial. However, oral insulin did not delay or prevent type 1 diabetes. Further studies are needed to explore the potential role of oral insulin in delaying diabetes in relatives similar to those in the subgroup with higher IAA levels.</description><identifier>ISSN: 0149-5992</identifier><identifier>EISSN: 1935-5548</identifier><identifier>DOI: 10.2337/diacare.28.5.1068</identifier><identifier>PMID: 15855569</identifier><identifier>CODEN: DICAD2</identifier><language>eng</language><publisher>Alexandria, VA: American Diabetes Association</publisher><subject>Administration, Oral ; Adolescent ; Adult ; Biological and medical sciences ; Child ; Child, Preschool ; Clinical trials ; Diabetes ; Diabetes Mellitus, Type 1 - drug therapy ; Diabetes Mellitus, Type 1 - epidemiology ; Diabetes Mellitus, Type 1 - prevention &amp; control ; Diabetes. Impaired glucose tolerance ; Dosage and administration ; Endocrine pancreas. Apud cells (diseases) ; Endocrinopathies ; Familial diseases ; Family ; Female ; Follow-Up Studies ; Genetic aspects ; Glucose Tolerance Test ; Humans ; Hypoglycemic Agents - administration &amp; dosage ; Hypoglycemic Agents - pharmacokinetics ; Insulin ; Insulin - administration &amp; dosage ; Insulin - pharmacokinetics ; Male ; Medical sciences ; Middle Aged ; Prevention ; Risk Factors ; Type 1 diabetes</subject><ispartof>Diabetes care, 2005-05, Vol.28 (5), p.1068-1076</ispartof><rights>2005 INIST-CNRS</rights><rights>COPYRIGHT 2005 American Diabetes Association</rights><rights>Copyright American Diabetes Association May 2005</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,778,782,27907,27908</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=16724303$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15855569$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Skyler, Jay S</creatorcontrib><creatorcontrib>Krischer, Jeffrey P</creatorcontrib><creatorcontrib>Wolfsdorf, Joseph</creatorcontrib><creatorcontrib>Cowie, Catherine</creatorcontrib><creatorcontrib>Palmer, Jerry P</creatorcontrib><creatorcontrib>Greenbaum, Carla</creatorcontrib><creatorcontrib>Cuthbertson, David</creatorcontrib><creatorcontrib>Rafkin-Mervis, Lisa E</creatorcontrib><creatorcontrib>Chase, H Peter</creatorcontrib><creatorcontrib>Leschek, Ellen</creatorcontrib><title>Effects of Oral Insulin in Relatives of Patients With Type 1 Diabetes: The Diabetes Prevention Trial-Type 1</title><title>Diabetes care</title><addtitle>Diabetes Care</addtitle><description>OBJECTIVE:--This randomized, double-masked, placebo-controlled clinical trial tested whether oral insulin administration could delay or prevent type 1 diabetes in nondiabetic relatives at risk for diabetes. RESEARCH DESIGN AND METHODS--We screened 103,391 first- and second-degree relatives of patients with type 1 diabetes and analyzed 97,273 samples for islet cell antibodies. A total of 3,483 were antibody positive; 2,523 underwent genetic, immunological, and metabolic staging to quantify risk of developing diabetes; 388 had a 5-year risk projection of 26-50%; and 372 (median age 10.25 years) were randomly assigned to oral insulin (7.5 mg/day) or placebo. Oral glucose tolerance tests were performed every 6 months. The median follow-up was 4.3 years, and the primary end point was diagnosis of diabetes. RESULTS:--Diabetes was diagnosed in 44 oral insulin and 53 placebo subjects. Annualized rate of diabetes was similar in both groups: 6.4% with oral insulin and 8.2% with placebo (hazard ratio 0.764, P = 0.189). In a hypothesis-generating analysis of a subgroup with insulin autoantibody (IAA) levels confirmed (on two occasions) [&gt;/=]80 nU/ml (n = 263), there was the suggestion of benefit: annualized diabetes rate 6.2% with oral insulin and 10.4% with placebo (0.566, P = 0.015). CONCLUSIONS:--It is possible to identify individuals at high risk for type 1 diabetes and to enroll them in a large, multisite, randomized, controlled clinical trial. However, oral insulin did not delay or prevent type 1 diabetes. Further studies are needed to explore the potential role of oral insulin in delaying diabetes in relatives similar to those in the subgroup with higher IAA levels.</description><subject>Administration, Oral</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Biological and medical sciences</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Clinical trials</subject><subject>Diabetes</subject><subject>Diabetes Mellitus, Type 1 - drug therapy</subject><subject>Diabetes Mellitus, Type 1 - epidemiology</subject><subject>Diabetes Mellitus, Type 1 - prevention &amp; control</subject><subject>Diabetes. Impaired glucose tolerance</subject><subject>Dosage and administration</subject><subject>Endocrine pancreas. Apud cells (diseases)</subject><subject>Endocrinopathies</subject><subject>Familial diseases</subject><subject>Family</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Genetic aspects</subject><subject>Glucose Tolerance Test</subject><subject>Humans</subject><subject>Hypoglycemic Agents - administration &amp; dosage</subject><subject>Hypoglycemic Agents - pharmacokinetics</subject><subject>Insulin</subject><subject>Insulin - administration &amp; dosage</subject><subject>Insulin - pharmacokinetics</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Prevention</subject><subject>Risk Factors</subject><subject>Type 1 diabetes</subject><issn>0149-5992</issn><issn>1935-5548</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNpt0V1rFDEUBuAgil2rP8AbHQS9mzHfk3hXatVCoUW3eDmcmZxsU2czazJT6L83uKuClIR8PgkvCSEvGW24EO17F2CAhA03jWoY1eYRWTErVK2UNI_JijJpa2UtPyLPcr6llEppzFNyxJRRSmm7Ij_OvMdhztXkq8sEY3Ue8zKGWJX6FUeYwx3-3rwqQ4wFfg_zTbW-32HFqo8Bepwxf6jWN_h3Vl0lvCs2TLFapwBjvefPyRMPY8YXh_6YXH86W59-qS8uP5-fnlzUXuh2rpUYJKhe2ZYJ07fohHPote4ViNJIxYzoHXNUcy3pwCxFcE4LsIZpME4ck3f7e3dp-rlgnrttyAOOI0ScltzptjWt4KzAN__B22lJsWTrOBdUtEbZguo92sCIXYh-mhMMG4xYnmuK6ENZPmGCS2alFsU3D_hSHG7D8OCBV4cUS79F1-1S2EK67_58UgFvDwDyAKNPEIeQ_zndclnSFvd67zxMHWxSMdffOGWCUmusbLn4BWQ5qHE</recordid><startdate>20050501</startdate><enddate>20050501</enddate><creator>Skyler, Jay S</creator><creator>Krischer, Jeffrey P</creator><creator>Wolfsdorf, Joseph</creator><creator>Cowie, Catherine</creator><creator>Palmer, Jerry P</creator><creator>Greenbaum, Carla</creator><creator>Cuthbertson, David</creator><creator>Rafkin-Mervis, Lisa E</creator><creator>Chase, H Peter</creator><creator>Leschek, Ellen</creator><general>American Diabetes Association</general><scope>FBQ</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>3V.</scope><scope>7RV</scope><scope>7X2</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88I</scope><scope>8AF</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>ATCPS</scope><scope>AZQEC</scope><scope>BEC</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HCIFZ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0K</scope><scope>M0R</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M2P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>S0X</scope><scope>7X8</scope></search><sort><creationdate>20050501</creationdate><title>Effects of Oral Insulin in Relatives of Patients With Type 1 Diabetes: The Diabetes Prevention Trial-Type 1</title><author>Skyler, Jay S ; Krischer, Jeffrey P ; Wolfsdorf, Joseph ; Cowie, Catherine ; Palmer, Jerry P ; Greenbaum, Carla ; Cuthbertson, David ; Rafkin-Mervis, Lisa E ; Chase, H Peter ; Leschek, Ellen</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-f367t-53c4a5b597138b7ed3ddef66b5a36b545183bd1d062640c190eadd63a9816a8d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Administration, Oral</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Biological and medical sciences</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Clinical trials</topic><topic>Diabetes</topic><topic>Diabetes Mellitus, Type 1 - drug therapy</topic><topic>Diabetes Mellitus, Type 1 - epidemiology</topic><topic>Diabetes Mellitus, Type 1 - prevention &amp; control</topic><topic>Diabetes. Impaired glucose tolerance</topic><topic>Dosage and administration</topic><topic>Endocrine pancreas. Apud cells (diseases)</topic><topic>Endocrinopathies</topic><topic>Familial diseases</topic><topic>Family</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Genetic aspects</topic><topic>Glucose Tolerance Test</topic><topic>Humans</topic><topic>Hypoglycemic Agents - administration &amp; dosage</topic><topic>Hypoglycemic Agents - pharmacokinetics</topic><topic>Insulin</topic><topic>Insulin - administration &amp; dosage</topic><topic>Insulin - pharmacokinetics</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Prevention</topic><topic>Risk Factors</topic><topic>Type 1 diabetes</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Skyler, Jay S</creatorcontrib><creatorcontrib>Krischer, Jeffrey P</creatorcontrib><creatorcontrib>Wolfsdorf, Joseph</creatorcontrib><creatorcontrib>Cowie, Catherine</creatorcontrib><creatorcontrib>Palmer, Jerry P</creatorcontrib><creatorcontrib>Greenbaum, Carla</creatorcontrib><creatorcontrib>Cuthbertson, David</creatorcontrib><creatorcontrib>Rafkin-Mervis, Lisa E</creatorcontrib><creatorcontrib>Chase, H Peter</creatorcontrib><creatorcontrib>Leschek, Ellen</creatorcontrib><collection>AGRIS</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing &amp; Allied Health Database</collection><collection>Agricultural Science Collection</collection><collection>Health &amp; Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>Agricultural &amp; Environmental Science Collection</collection><collection>ProQuest Central Essentials</collection><collection>eLibrary</collection><collection>ProQuest Central</collection><collection>Natural Science Collection (ProQuest)</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>SciTech Premium Collection</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Database (Alumni Edition)</collection><collection>Agricultural Science Database</collection><collection>Consumer Health Database</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Science Database (ProQuest)</collection><collection>Research Library (Corporate)</collection><collection>Nursing &amp; Allied Health Premium</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>ProQuest Central Basic</collection><collection>SIRS Editorial</collection><collection>MEDLINE - Academic</collection><jtitle>Diabetes care</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Skyler, Jay S</au><au>Krischer, Jeffrey P</au><au>Wolfsdorf, Joseph</au><au>Cowie, Catherine</au><au>Palmer, Jerry P</au><au>Greenbaum, Carla</au><au>Cuthbertson, David</au><au>Rafkin-Mervis, Lisa E</au><au>Chase, H Peter</au><au>Leschek, Ellen</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effects of Oral Insulin in Relatives of Patients With Type 1 Diabetes: The Diabetes Prevention Trial-Type 1</atitle><jtitle>Diabetes care</jtitle><addtitle>Diabetes Care</addtitle><date>2005-05-01</date><risdate>2005</risdate><volume>28</volume><issue>5</issue><spage>1068</spage><epage>1076</epage><pages>1068-1076</pages><issn>0149-5992</issn><eissn>1935-5548</eissn><coden>DICAD2</coden><abstract>OBJECTIVE:--This randomized, double-masked, placebo-controlled clinical trial tested whether oral insulin administration could delay or prevent type 1 diabetes in nondiabetic relatives at risk for diabetes. RESEARCH DESIGN AND METHODS--We screened 103,391 first- and second-degree relatives of patients with type 1 diabetes and analyzed 97,273 samples for islet cell antibodies. A total of 3,483 were antibody positive; 2,523 underwent genetic, immunological, and metabolic staging to quantify risk of developing diabetes; 388 had a 5-year risk projection of 26-50%; and 372 (median age 10.25 years) were randomly assigned to oral insulin (7.5 mg/day) or placebo. Oral glucose tolerance tests were performed every 6 months. The median follow-up was 4.3 years, and the primary end point was diagnosis of diabetes. RESULTS:--Diabetes was diagnosed in 44 oral insulin and 53 placebo subjects. Annualized rate of diabetes was similar in both groups: 6.4% with oral insulin and 8.2% with placebo (hazard ratio 0.764, P = 0.189). In a hypothesis-generating analysis of a subgroup with insulin autoantibody (IAA) levels confirmed (on two occasions) [&gt;/=]80 nU/ml (n = 263), there was the suggestion of benefit: annualized diabetes rate 6.2% with oral insulin and 10.4% with placebo (0.566, P = 0.015). CONCLUSIONS:--It is possible to identify individuals at high risk for type 1 diabetes and to enroll them in a large, multisite, randomized, controlled clinical trial. However, oral insulin did not delay or prevent type 1 diabetes. Further studies are needed to explore the potential role of oral insulin in delaying diabetes in relatives similar to those in the subgroup with higher IAA levels.</abstract><cop>Alexandria, VA</cop><pub>American Diabetes Association</pub><pmid>15855569</pmid><doi>10.2337/diacare.28.5.1068</doi><tpages>9</tpages></addata></record>
fulltext fulltext
identifier ISSN: 0149-5992
ispartof Diabetes care, 2005-05, Vol.28 (5), p.1068-1076
issn 0149-5992
1935-5548
language eng
recordid cdi_proquest_miscellaneous_67787321
source MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals
subjects Administration, Oral
Adolescent
Adult
Biological and medical sciences
Child
Child, Preschool
Clinical trials
Diabetes
Diabetes Mellitus, Type 1 - drug therapy
Diabetes Mellitus, Type 1 - epidemiology
Diabetes Mellitus, Type 1 - prevention & control
Diabetes. Impaired glucose tolerance
Dosage and administration
Endocrine pancreas. Apud cells (diseases)
Endocrinopathies
Familial diseases
Family
Female
Follow-Up Studies
Genetic aspects
Glucose Tolerance Test
Humans
Hypoglycemic Agents - administration & dosage
Hypoglycemic Agents - pharmacokinetics
Insulin
Insulin - administration & dosage
Insulin - pharmacokinetics
Male
Medical sciences
Middle Aged
Prevention
Risk Factors
Type 1 diabetes
title Effects of Oral Insulin in Relatives of Patients With Type 1 Diabetes: The Diabetes Prevention Trial-Type 1
url https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-16T09%3A17%3A04IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_proqu&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Effects%20of%20Oral%20Insulin%20in%20Relatives%20of%20Patients%20With%20Type%201%20Diabetes:%20The%20Diabetes%20Prevention%20Trial-Type%201&rft.jtitle=Diabetes%20care&rft.au=Skyler,%20Jay%20S&rft.date=2005-05-01&rft.volume=28&rft.issue=5&rft.spage=1068&rft.epage=1076&rft.pages=1068-1076&rft.issn=0149-5992&rft.eissn=1935-5548&rft.coden=DICAD2&rft_id=info:doi/10.2337/diacare.28.5.1068&rft_dat=%3Cgale_proqu%3EA132419463%3C/gale_proqu%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=223037859&rft_id=info:pmid/15855569&rft_galeid=A132419463&rfr_iscdi=true