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1. Update on transcobalamin deficiency: clinical presentation, treatment and outcome

Author

Trakadis, Y. J., Alfares, A., Bodamer, O. A., Buyukavci, M., Christodoulou, J., Connor, P., Glamuzina, E., Gonzalez-Fernandez, F., Bibi, H., Echenne, B., Manoli, I., Mitchell, J., Nordwall, M., Prasad, C., Scaglia, F., Schiff, M., Schrewe, B., Touati, G., Tchan, M. C., Varet, B., Venditti, C. P., Zafeiriou, D., Rupar, C. A., Rosenblatt, D. S., Watkins, D., and Braverman, N.

Published
2014
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6. Effect of hydrolyzed infant formula vs conventional formula on risk of type 1 diabetes the TRIGR randomized clinical trial

Author

Knip M., Akerblom H. K., Altaji E., Becker D., Bruining J., Castano L., Danne T., De Beaufort C., Dosch H. -M., Dupre J., Fraser W. D., Howard N., Ilonen J., Konrad D., Kordonouri O., Krischer J. P., Lawson M. L., Ludvigsson J., Madacsy L., Mahon J. L., Ormisson A., Palmer J. P., Pozzilli P., Savilahti E., Serrano-Rios M., Songini M., Taback S., Vaarala O., White N. H., Virtanen S. M., Wasikowa R., Mandrup-Poulsen T., Arjas E., Lernmark A., Laara E., Schmidt B., Hyytinen M., Koski K., Koski M., Merentie K., Pajakkala E., Reunanen A., Salonen M., Terhonen T., Virkkunen S., Cuthbertson D., Gainer B., Hadley D., Malloy J., Nallamshetty L., Shanker L., Bradley B., Lough G., Fraser W., Sermer M., Taback S. P., Franciscus M., Nucci A., Palmer J., Alahuhta K., Barlund S., Korhonen T., Kovanen L., Lehtonen E., Niinisto S., Pekkala M., Sorkio S., Toivanen L., Vahatalo L., Uusitalo U., Ohman T., Bongiorno R., Catteau J., Fraser G., Lloyd M., Crock P., Giles M., Siech K., See D. W., Brown C., Craig M., Johnston A., Bere L. J., Clarson C. L., Jenner M., McManus R., Renato N., Lovell M., Higo D., Kent N., Kwan J., Marshall C., Metzger D., Chanoine J. -P., Stewart L., Thompson D., Edwards A., Lange I., Mercer J., Pacaud D., Josephine H., Schwarz W., Stephure D. K., Boer J., Chatur T., Chick C., Couch B., Demianczuk N., Girgis R., Marks S., Ryan E., Thompson M., Dean H. J., Grant L., Hamelin K., LaForte J., Murphy L., Catte D., Schneider C., Sellers E. A. C., Woo V., Boland A., Clark H. D., Cooper T., Gruslin A., Karovitch A., Keely E., Malcolm J. C., Sauro V., Tawagi G. F., Andrighetti S., Arnold G., Barrett J., Blumer I., Daneman D., Donat D., Ehrlich R., Feig D., Gottesman I., Gysler M., Karkanis S., Kenshole A., Knight B., Lackie E., Lewis V., Martin M. J., Maxwell C., Oliver G., Panchum P., Shilletto N., Simone A., Skidmore M., Turrini T., Wong S., Allen C., Belanger L., Bouchard I., Ferland S., Frenette L., Garrido-Russo M., Leblanc M., Imbeault J., Morin V., Olivier G., Weisnagell J., Costain G., Dornan J., Heath K., MacSween M. -C., McGibbon A., Ramsay C., Sanderson F., Sanderson S., Benabdesselam L., Gonthier M., Huot C., Thibeault M., Laforte D., Legault L., Perron P., Armson A., Canning P., Cummings E. A., Ivanko V., McLeod L., Mokashi A., Scott K., Bridger T., Crane J., Crummell C., Curtis J. C., Dawson C., Joyce C., Newhook L. A., Newman S., Druken E., Begum-Hasan J., Breen A., Houlden R., Woods M., Carrson G., Kelly S., Martel M. J., Penner M., Sankaran K., Hardy-Brown K., King N., White R. A., Park M., Popkin J., Robson L., Coles K., Al Taji E., Cerna M., Cerny M., Francova H., Hainerova I., Kothankova H., Koukalova R., Krakorova V., Mendlova P., Sitova R., Stechova K., Vavrinec J., Vosahlo J., Zlatohlavkova B., Brazdova L., Faksova P., Gregorova D., Kantor L., Malkova K., Venhacova J., Venhacova P., Cipra A., Skvor J., Budejovice C., Tomsikova Z., Botkova-Krauseova H., Mockova A., Paterova P., Gogelova P., Kandrnalova J., Einberg U., Jakovlev U., Posiadlo S., Rannaste E., Raukas R., Riikjarv M. -A., Valla K., Astover V., Kirss A., Retpap J., Taht E., Tillmann V., Vahtra S., Heikkila M., Hirvasniemi M., Luopajarvi K., Johansson S., Kleemola P., Laukkanen E., Parkkola A., Pigg H. -M., Puttonen H., Renlund M., Salonen K., Suomalainen H., Tenkula T., Teramo K., Jarvenpaa A. -L., Hamalainen A. -M., Jussila R., Kiiveri S., Haavisto H., Holopainen S., Kupiainen H., Leeve T., Lumme K., Nironen T., Tenhola S., Tiilikainen T., Keinonen H., Lautala P., Salonen P., Vesanto M., Aspholm A. S., Asunta P., Ikavalko H., Jason E., Jaminki S., Kekki P., Koskinen M., Lehtimaki S., Lahde J., Makela M., Peltoniemi S., Poutiainen L., Ranta K., Salonsaari T., Sarviharju-Tujula S. -L., Selvenius J., Siljander H., Haanpaa P. -L., Holm C., Juutilainen A., Jarvelainen V., Kangaskolkka-Keskilohko A. -M., Laino E., Marjamaki L., Suominen E., Ylitalo S., Hokkanen M., Lounamaa R., Matikainen M., Nuuja A., Paalanen I., Puupponen A. R., Salo-Edwards H., Alanne S., Kultti T., Linjama H., Muhonen K., Vaaraniemi M., Talvitie T., Backman M., Hanhijarvi R., Koivula P., Lindstrom K., Martikainen A., Nurmi P., Bjork A., Huopio H., Komulainen J., Lehtomaki S., Muikku E., Pesola J., Sankilampi U., Arkkola T., Hekkala A., Jurvakainen S., Koivikko M. -L., Kahonen M., Leinonen E., Mykkanen T., Pohjola H., Riikonen K., Niittyvuopio A., Stenius A., Tapanainen P., Veijola R., Alar A., Jovio S., Korpela P., Makinen E., Hietanen L., Kivisto J., Kaar M. -L., Lehtimaki P., Mustila T., Popov E., Saatela S., Taittonen L., Ahtiainen K., Laaksonen N., Luoto M., Viitala J., Virransalo R., Nykanen P., Paajanen S., Parkkinen S., Pyrhonen H., Sarkka T., Aschemeier B., Bektas S., Biester T., Datz N., Deiss D., Fath M., Lupke K., Muller B., Nestoris C., Rothes S., Sadeghian E., Semler K., Arato A., Krikovszky D., Nobilis A., Szenasi J., Benevento D., Anguissola G. B., Biagioni M., Bizzarri C., Cherubini V., Ferrito L., Giordano C., Giorgetti C., Khazrai Y. M., Kyanvash S., Maddaloni E., Napoli A., Piergiovanni F., Pitocco D., Suraci T., Tabacco G., Valente L., Visalli N., Carboni M. B., Cavallo R., Cau V., Isola C., Ledda A., Loddo M., Mannu C., Pettinau M., Pisano S., Porceddu M., Putzu C., Rita A., Peters D., Schierloh U., Bisschoff M., Blonk L., Lappenschaar T., Manai B., Seesink M., Sperling-Conrad M., Verhagen M., Zoethout J. A., Basiak A., Chalas M., Chesiak M., Gramza A., Iwankiewicz J., Sieradzan E., Wikiera B., Ciechanowska M., Dziatkowiak H., Futona B., Gorska A., Glowacka-Wony M., Kaim I., Klich B., Starzyk J., Wolanin M., Tokarska L., Chucherco D., Deja G., Firek-Pedras M., Jarosz-Chobot P., Kalina M., Kutrowska-Adamusiak K., Minkina-Pedras M., Muchaka-Bianga M., Bodalski J., Mlynarski W., Szadkowska A., Cieslak A., Cypryk K., Dziatosz K., Jastzebowska J., Krysiak A., Szymanska U., Wilcznski J., Zawodniak-Szalapska M., Aguay A., Bilbao J. R., Chueca M., Cortazar A., Echarte G., Frutos T. G., Jimenez P., Martul P., Moreno A., Oyarzabal M., Rica I., Salgado Y., Martinez-Larrad M. T., Hawkins F. G., Hernandez R., Herranz L., Pallardo L. F., Deibarra L. S., Fernandez B. H., Luis J. L., Ortiz-Quintana L., Recarte P. P., Arnau D. R., Aronsson L., Boden S., Fredriksson J., Isacsson E., Johansson I., Karlsson E., Lock C., Sandstrom A. -M., Konefal M. S., Andreasson C., Dahlstrom U., Hanas R., Lundqvist K., Windell L., Jansson I., Karlsson A. -K., Lindbladh B., Odenman I., Pettersson C., Sundberg F., Sundqvist M., Aronsson S., Bellman I., Bengtsson A. -B., Lyden G. -B., Nilsson N. -O., Soderblom M., Unt C., Augustsson M., Bengtsson M., Fors H., Helmrich A., Johansson T. O., Andersson A. -C., Boiard-Stomlid A., Hellgren G., Kallsholm H., Lindqvist J., Nilsson M., Nordwall M., Stromstedt C., Ahsberg C., Lindh A., Lindhe C., Samuelsson C., Wiik A., Edenwall H., Ljumgcrantz M., Persson I. -B., Strigard E., Svensson B. -L., Aman J., Breivik G. -E., Detlofsson I. -L., Kroon M., Sarnblad S., Johansson C., Ilvered R., Lundberg A., Akesson K., Beccarelli A., Gadient M., Rappold-Amrein C., Schoenle E., Daftary A., Damagro-Elias M. E., Gilmour C., Klein M. B., Lain C., Salerno D., Smith M. E., Vats K., Pfaff D. J., Malone P., Mansfield P., Munns M., Nickel K., Pompilio K., Siemion W., Taculad R., Van Horn K., Zdanadewic M., Chambliss C., Jones J., Sadler M., Tanner-Blasiar M., Bell C., Camper N., Devaskar S., Devaskar U., Horowitz H., Rogers L., Shannahan R., Silk K., Bermudez Z., Colon R., Frazer T., Martinez-Nieves B., Torres J., Vega J., Chan M., Cook S., Goland R., Greenberg E., Jules N., Montes J., Nelson M., Parra-Valencia Z., Schachner H., Softness B., Kiviniemi M., Suomenin R., Alexander A., Hyrckowian E., Nichol L., Trucco M., Karjalainen E., Louhio T., Sarnesto A., Valtonen E., Davydova B., Helander S., Hamalainen J., Harkonen T., Joutsjoki L., Kararic M., Latva-Koivisto M., Lonn E., Nurmi T., Ollila I., Rinkinen J., Ronkainen M., Tukiainen H., Cederlof A., Kiikeri M., Tsupari S., Cheng R., Bryant K., Chan Y., Maezawa Y., Paltser G., Rasavi R., Tsui H., Winer S., Wu P., Yantha J., Pediatrics, Knip M., Akerblom H.K., Altaji E., Becker D., Bruining J., Castano L., Danne T., De Beaufort C., Dosch H.-M., Dupre J., Fraser W.D., Howard N., Ilonen J., Konrad D., Kordonouri O., Krischer J.P., Lawson M.L., Ludvigsson J., Madacsy L., Mahon J.L., Ormisson A., Palmer J.P., Pozzilli P., Savilahti E., Serrano-Rios M., Songini M., Taback S., Vaarala O., White N.H., Virtanen S.M., Wasikowa R., Mandrup-Poulsen T., Arjas E., Lernmark A., Laara E., Schmidt B., Hyytinen M., Koski K., Koski M., Merentie K., Pajakkala E., Reunanen A., Salonen M., Terhonen T., Virkkunen S., Cuthbertson D., Gainer B., Hadley D., Malloy J., Nallamshetty L., Shanker L., Bradley B., Lough G., Fraser W., Sermer M., Taback S.P., Franciscus M., Nucci A., Palmer J., Alahuhta K., Barlund S., Korhonen T., Kovanen L., Lehtonen E., Niinisto S., Pekkala M., Sorkio S., Toivanen L., Vahatalo L., Uusitalo U., Ohman T., Bongiorno R., Catteau J., Fraser G., Lloyd M., Crock P., Giles M., Siech K., See D.W., Brown C., Craig M., Johnston A., Bere L.J., Clarson C.L., Jenner M., McManus R., Renato N., Lovell M., Higo D., Kent N., Kwan J., Marshall C., Metzger D., Chanoine J.-P., Stewart L., Thompson D., Edwards A., Lange I., Mercer J., Pacaud D., Josephine H., Schwarz W., Stephure D.K., Boer J., Chatur T., Chick C., Couch B., Demianczuk N., Girgis R., Marks S., Ryan E., Thompson M., Dean H.J., Grant L., Hamelin K., LaForte J., Murphy L., Catte D., Schneider C., Sellers E.A.C., Woo V., Boland A., Clark H.D., Cooper T., Gruslin A., Karovitch A., Keely E., Malcolm J.C., Sauro V., Tawagi G.F., Andrighetti S., Arnold G., Barrett J., Blumer I., Daneman D., Donat D., Ehrlich R., Feig D., Gottesman I., Gysler M., Karkanis S., Kenshole A., Knight B., Lackie E., Lewis V., Martin M.J., Maxwell C., Oliver G., Panchum P., Shilletto N., Simone A., Skidmore M., Turrini T., Wong S., Allen C., Belanger L., Bouchard I., Ferland S., Frenette L., Garrido-Russo M., Leblanc M., Imbeault J., Morin V., Olivier G., Weisnagell J., Costain G., Dornan J., Heath K., MacSween M.-C., McGibbon A., Ramsay C., Sanderson F., Sanderson S., Benabdesselam L., Gonthier M., Huot C., Thibeault M., Laforte D., Legault L., Perron P., Armson A., Canning P., Cummings E.A., Ivanko V., McLeod L., Mokashi A., Scott K., Bridger T., Crane J., Crummell C., Curtis J.C., Dawson C., Joyce C., Newhook L.A., Newman S., Druken E., Begum-Hasan J., Breen A., Houlden R., Woods M., Carrson G., Kelly S., Martel M.J., Penner M., Sankaran K., Hardy-Brown K., King N., White R.A., Park M., Popkin J., Robson L., Coles K., Al Taji E., Cerna M., Cerny M., Francova H., Hainerova I., Kothankova H., Koukalova R., Krakorova V., Mendlova P., Sitova R., Stechova K., Vavrinec J., Vosahlo J., Zlatohlavkova B., Brazdova L., Faksova P., Gregorova D., Kantor L., Malkova K., Venhacova J., Venhacova P., Cipra A., Skvor J., Budejovice C., Tomsikova Z., Botkova-Krauseova H., Mockova A., Paterova P., Gogelova P., Kandrnalova J., Einberg U., Jakovlev U., Posiadlo S., Rannaste E., Raukas R., Riikjarv M.-A., Valla K., Astover V., Kirss A., Retpap J., Taht E., Tillmann V., Vahtra S., Heikkila M., Hirvasniemi M., Luopajarvi K., Johansson S., Kleemola P., Laukkanen E., Parkkola A., Pigg H.-M., Puttonen H., Renlund M., Salonen K., Suomalainen H., Tenkula T., Teramo K., Jarvenpaa A.-L., Hamalainen A.-M., Jussila R., Kiiveri S., Haavisto H., Holopainen S., Kupiainen H., Leeve T., Lumme K., Nironen T., Tenhola S., Tiilikainen T., Keinonen H., Lautala P., Salonen P., Vesanto M., Aspholm A.S., Asunta P., Ikavalko H., Jason E., Jaminki S., Kekki P., Koskinen M., Lehtimaki S., Lahde J., Makela M., Peltoniemi S., Poutiainen L., Ranta K., Salonsaari T., Sarviharju-Tujula S.-L., Selvenius J., Siljander H., Haanpaa P.-L., Holm C., Juutilainen A., Jarvelainen V., Kangaskolkka-Keskilohko A.-M., Laino E., Marjamaki L., Suominen E., Ylitalo S., Hokkanen M., Lounamaa R., Matikainen M., Nuuja A., Paalanen I., Puupponen A.R., Salo-Edwards H., Alanne S., Kultti T., Linjama H., Muhonen K., Vaaraniemi M., Talvitie T., Backman M., Hanhijarvi R., Koivula P., Lindstrom K., Martikainen A., Nurmi P., Bjork A., Huopio H., Komulainen J., Lehtomaki S., Muikku E., Pesola J., Sankilampi U., Arkkola T., Hekkala A., Jurvakainen S., Koivikko M.-L., Kahonen M., Leinonen E., Mykkanen T., Pohjola H., Riikonen K., Niittyvuopio A., Stenius A., Tapanainen P., Veijola R., Alar A., Jovio S., Korpela P., Makinen E., Hietanen L., Kivisto J., Kaar M.-L., Lehtimaki P., Mustila T., Popov E., Saatela S., Taittonen L., Ahtiainen K., Laaksonen N., Luoto M., Viitala J., Virransalo R., Nykanen P., Paajanen S., Parkkinen S., Pyrhonen H., Sarkka T., Aschemeier B., Bektas S., Biester T., Datz N., Deiss D., Fath M., Lupke K., Muller B., Nestoris C., Rothes S., Sadeghian E., Semler K., Arato A., Krikovszky D., Nobilis A., Szenasi J., Benevento D., Anguissola G.B., Biagioni M., Bizzarri C., Cherubini V., Ferrito L., Giordano C., Giorgetti C., Khazrai Y.M., Kyanvash S., Maddaloni E., Napoli A., Piergiovanni F., Pitocco D., Suraci T., Tabacco G., Valente L., Visalli N., Carboni M.B., Cavallo R., Cau V., Isola C., Ledda A., Loddo M., Mannu C., Pettinau M., Pisano S., Porceddu M., Putzu C., Rita A., Peters D., Schierloh U., Bisschoff M., Blonk L., Lappenschaar T., Manai B., Seesink M., Sperling-Conrad M., Verhagen M., Zoethout J.A., Basiak A., Chalas M., Chesiak M., Gramza A., Iwankiewicz J., Sieradzan E., Wikiera B., Ciechanowska M., Dziatkowiak H., Futona B., Gorska A., Glowacka-Wony M., Kaim I., Klich B., Starzyk J., Wolanin M., Tokarska L., Chucherco D., Deja G., Firek-Pedras M., Jarosz-Chobot P., Kalina M., Kutrowska-Adamusiak K., Minkina-Pedras M., Muchaka-Bianga M., Bodalski J., Mlynarski W., Szadkowska A., Cieslak A., Cypryk K., Dziatosz K., Jastzebowska J., Krysiak A., Szymanska U., Wilcznski J., Zawodniak-Szalapska M., Aguay A., Bilbao J.R., Chueca M., Cortazar A., Echarte G., Frutos T.G., Jimenez P., Martul P., Moreno A., Oyarzabal M., Rica I., Salgado Y., Martinez-Larrad M.T., Hawkins F.G., Hernandez R., Herranz L., Pallardo L.F., Deibarra L.S., Fernandez B.H., Luis J.L., Ortiz-Quintana L., Recarte P.P., Arnau D.R., Aronsson L., Boden S., Fredriksson J., Isacsson E., Johansson I., Karlsson E., Lock C., Sandstrom A.-M., Konefal M.S., Andreasson C., Dahlstrom U., Hanas R., Lundqvist K., Windell L., Jansson I., Karlsson A.-K., Lindbladh B., Odenman I., Pettersson C., Sundberg F., Sundqvist M., Aronsson S., Bellman I., Bengtsson A.-B., Lyden G.-B., Nilsson N.-O., Soderblom M., Unt C., Augustsson M., Bengtsson M., Fors H., Helmrich A., Johansson T.O., Andersson A.-C., Boiard-Stomlid A., Hellgren G., Kallsholm H., Lindqvist J., Nilsson M., Nordwall M., Stromstedt C., Ahsberg C., Lindh A., Lindhe C., Samuelsson C., Wiik A., Edenwall H., Ljumgcrantz M., Persson I.-B., Strigard E., Svensson B.-L., Aman J., Breivik G.-E., Detlofsson I.-L., Kroon M., Sarnblad S., Johansson C., Ilvered R., Lundberg A., Akesson K., Beccarelli A., Gadient M., Rappold-Amrein C., Schoenle E., Daftary A., Damagro-Elias M.E., Gilmour C., Klein M.B., Lain C., Salerno D., Smith M.E., Vats K., Pfaff D.J., Malone P., Mansfield P., Munns M., Nickel K., Pompilio K., Siemion W., Taculad R., Van Horn K., Zdanadewic M., Chambliss C., Jones J., Sadler M., Tanner-Blasiar M., Bell C., Camper N., Devaskar S., Devaskar U., Horowitz H., Rogers L., Shannahan R., Silk K., Bermudez Z., Colon R., Frazer T., Martinez-Nieves B., Torres J., Vega J., Chan M., Cook S., Goland R., Greenberg E., Jules N., Montes J., Nelson M., Parra-Valencia Z., Schachner H., Softness B., Kiviniemi M., Suomenin R., Alexander A., Hyrckowian E., Nichol L., Trucco M., Karjalainen E., Louhio T., Sarnesto A., Valtonen E., Davydova B., Helander S., Hamalainen J., Harkonen T., Joutsjoki L., Kararic M., Latva-Koivisto M., Lonn E., Nurmi T., Ollila I., Rinkinen J., Ronkainen M., Tukiainen H., Cederlof A., Kiikeri M., Tsupari S., Cheng R., Bryant K., Chan Y., Maezawa Y., Paltser G., Rasavi R., Tsui H., Winer S., Wu P., Yantha J., University of Zurich, and Knip, Mikael

Subjects
Male, Risk, medicine.medical_specialty, Casein, Breastfeeding, 030209 endocrinology & metabolism, 610 Medicine & health, 2700 General Medicine, Endocrinology and Diabetes, Disease-Free Survival, law.invention, Follow-Up Studie, Nutrition Policy, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, SDG 3 - Good Health and Well-being, law, Internal medicine, Diabetes mellitus, medicine, Humans, Cumulative incidence, 030212 general & internal medicine, Child, Infant Nutritional Physiological Phenomena, Original Investigation, 2. Zero hunger, Type 1 diabetes, business.industry, Hazard ratio, Absolute risk reduction, Infant, Newborn, Caseins, General Medicine, ta3121, medicine.disease, Infant Formula, 3. Good health, Diabetes Mellitus, Type 1, Infant formula, 10036 Medical Clinic, Endokrinologi och diabetes, Female, business, Human, Follow-Up Studies
Abstract

IMPORTANCE Early exposure to complex dietary proteins may increase the risk of type 1 diabetes in children with genetic disease susceptibility. There are no intact proteins in extensively hydrolyzed formulas. OBJECTIVE To test the hypothesis that weaning to an extensively hydrolyzed formula decreases the cumulative incidence of type 1 diabetes in young children. DESIGN, SETTING, AND PARTICIPANTS An international double-blind randomized clinical trial of 2159 infants with human leukocyte antigen-conferred disease susceptibility and a first-degree relative with type 1 diabetes recruited from May 2002 to January 2007 in 78 study centers in 15 countries; 1081 were randomized to be weaned to the extensively hydrolyzed casein formula and 1078 to a conventional formula. The follow-up of the participants ended on February 28, 2017. INTERVENTIONS The participants received either a casein hydrolysate or a conventional adapted cows milk formula supplemented with 20% of the casein hydrolysate. The minimum duration of study formula exposure was 60 days by 6 to 8 months of age. MAIN OUTCOMES AND MEASURES Primary outcome was type 1 diabetes diagnosed according to World Health Organization criteria. Secondary outcomes included age at diabetes diagnosis and safety (adverse events). RESULTS Among 2159 newborn infants (1021 female [47.3%]) who were randomized, 1744 (80.8%) completed the trial. The participants were observed for a median of 11.5 years (quartile [Q] 1-Q3, 10.2-12.8). The absolute risk of type 1 diabetes was 8.4% among those randomized to the casein hydrolysate (n = 91) vs 7.6% among those randomized to the conventional formula (n = 82) (difference, 0.8%[95% CI, -1.6% to 3.2%]). The hazard ratio for type 1 diabetes adjusted for human leukocyte antigen risk group, duration of breastfeeding, duration of study formula consumption, sex, and region while treating study center as a random effect was 1.1 (95% CI, 0.8 to 1.5; P = .46). The median age at diagnosis of type 1 diabetes was similar in the 2 groups (6.0 years [Q1-Q3, 3.1-8.9] vs 5.8 years [Q1-Q3, 2.6-9.1]; difference, 0.2 years [95% CI, -0.9 to 1.2]). Upper respiratory infections were the most common adverse event reported (frequency, 0.48 events/year in the hydrolysate group and 0.50 events/year in the control group). CONCLUSIONS AND RELEVANCE Among infants at risk for type 1 diabetes, weaning to a hydrolyzed formula compared with a conventional formula did not reduce the cumulative incidence of type 1 diabetes after median follow-up for 11.5 years. These findings do not support a need to revise the dietary recommendations for infants at risk for type 1 diabetes. Funding Agencies|Eunice Kennedy Shriver National Institute of Child Health and Development (NICHD); National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health [HD040364, HD042444, HD051997]; Canadian Institutes of Health Research; Commission of the European Communities [QLK1-2002-00372]; European Foundation for the Study of Diabates/JDRF/Novo Nordisk; Academy of Finland (Centre of Excellence in Molecular Systems Immunology and Physiology Research) [250114]; Dutch Diabetes Research Foundation; Finnish Diabetes Research Foundation; JDRF

Published
2018

7. Regional differences in milk and complementary feeding patterns in infants participating in an international nutritional type 1 diabetes prevention trial

Author

Nucci, A. M., Virtanen, S. M., Sorkio, S., Barlund, S., Cuthbertson, D., Uusitalo, U., Lawson, M. L., Salonen, M., Berseth, C. L., Ormisson, A., Lehtonen, E., Savilahti, E., Becker, D. J., Dupre, J., Krischer, J. P., Knip, M., Akerblom, H. K., Mandrup-Poulsen, T., Arjas, E., Laara, E., Lernmark, A., Schmidt, B., Hyytinen, M., Koski, K., Koski, M., Pajakkala, E., Shanker, L., Bradley, B., Dosch, H. -M., Fraser, W., Lawson, M., Mahon, J. L., Sermer, M., Taback, S. P., Becker, D., Franciscus, M., Nucci, A., Palmer, J., Pekkala, M., Catteau, J., Howard, N., Crock, P., Craig, M., Clarson, C. L., Bere, L., Thompson, D., Metzger, D., Kwan, J., Stephure, D. K., Pacaud, D., Ho, J., Schwarz, W., Girgis, R., Thompson, M., Catte, D., Daneman, D., Martin, M. -J., Morin, V., Frenette, L., Ferland, S., Sanderson, S., Heath, K., Huot, C., Gonthier, M., Thibeault, M., Legault, L., Laforte, D., Cummings, E. A., Scott, K., Bridger, T., Crummell, C., Newman, S., Houlden, R., Breen, A., Carson, G., Kelly, S., Sankaran, K., Penner, M., White, R. A., Hardy Brown, K., King, N., Popkin, J., Robson, L., Coles, K., Al Taji, E., Aldhoon, I., Mendlova, P., Vavrinec, J., Vosahlo, J., Brazdova, L., Venhacova, J., Venhacova, P., Cipra, A., Tomsikova, Z., Paterova, P., Gogelova, P., Einberg, U., Riikjarv, M. -A., Tillmann, V., Hirvasniemi, M., Kleemola, P., Parkkola, A., Suomalainen, H., Jarvenpaa, A. -L., Hamalainen, A. -M., Haavisto, H., Tenhola, S., Lautala, P., Salonen, P., Aspholm, S., Siljander, H., Holm, C., Ylitalo, S., Lounamaa, R., Nuuja, A., Talvitie, T., Lindstrom, K., Huopio, H., Pesola, J., Veijola, R., Tapanainen, P., Alar, A., Korpela, P., Kaar, M. -L., Mustila, T., Virransalo, R., Nykanen, P., Aschemeier, B., Danne, T., Kordonouri, O., Krikovszky, D., Madacsy, L., Khazrai, Y. M., Maddaloni, E., Pozzilli, P., Mannu, C., Songini, M., de Beaufort, C., Schierloh, U., Bruining, J., Basiak, A., Wasikowa, R., Ciechanowska, M., Deja, G., Jarosz-Chobot, P., Szadkowska, A., Cypryk, K., Zawodniak-Szalapska, M., Castano, L., Gonzalez Frutos, T., Oyarzabal, M., Serrano-Rios, M., Martinez-Larrad, M. T., Hawkins, F. G., Rodriguez Arnau, D., Ludvigsson, J., Smolinska Konefal, M., Hanas, R., Lindblad, B., Nilsson, N. -O., Fors, H., Nordwall, M., Lindh, A., Edenwall, H., Aman, J., Johansson, C., Gadient, M., Schoenle, E., Daftary, A., Klein, M. B., Gilmour, C., Malone, P., Tanner-Blasiar, M., White, N., Devaskar, U., Horowitz, H., Rogers, L., Colon, R., Frazer, T., Torres, J., Goland, R., Greenberg, E., Nelson, M., Schachner, H., Softness, B., Ilonen, J., Trucco, M., Nichol, L., Harkonen, T., Vaarala, O., and Luopajarvi, K.

Subjects
Canada, endocrine system diseases, infant feeding, breastfeeding, type 1 diabetes, breastfeeding duration, complementary feeding, infant formula, Infant, Article, United States, Diet, Nutrition Policy, Europe, Diabetes Mellitus, Type 1, Milk, Nutrition Assessment, Double-Blind Method, Surveys and Questionnaires, Animals, Humans, Infant Food, Prospective Studies, Infant Nutritional Physiological Phenomena
Abstract

Differences in breastfeeding, other milk feeding and complementary feeding patterns were evaluated in infants at increased genetic risk with and without maternal type 1 diabetes (T1D). The Trial to Reduce IDDM in the Genetically at Risk is an international nutritional primary prevention double-blinded randomized trial to test whether weaning to extensively hydrolyzed vs. intact cow's milk protein formula will decrease the development of T1D-associated autoantibodies and T1D. Infant diet was prospectively assessed at two visits and seven telephone interviews between birth and 8 months. Countries were grouped into seven regions: Australia, Canada, Northern Europe, Southern Europe, Central Europe I, Central Europe II and the United States. Newborn infants with a first-degree relative with T1D and increased human leukocyte antigen-conferred susceptibility to T1D were recruited. A lower proportion of infants born to mothers with than without T1D were breastfed until 6 months of age in all regions (range, 51% to 60% vs. 70% to 80%). Complementary feeding patterns differed more by region than by maternal T1D. In Northern Europe, a higher proportion of infants consumed vegetables and fruits daily compared with other regions. Consumption of meat was more frequent in all European regions, whereas cereal consumption was most frequent in Southern Europe, Canada and the United States. Maternal T1D status was associated with breastfeeding and other milk feeding patterns similarly across regions but was unrelated to the introduction of complementary foods. Infant feeding patterns differed significantly among regions and were largely inconsistent with current recommended guidelines.

Published
2017

8. BMI is an important driver of β-cell loss in type 1 diabetes upon diagnosis in 10 to 18-year-old children

Author

Lauria, A, primary, Barker, A, additional, Schloot, N, additional, Hosszufalusi, N, additional, Ludvigsson, J, additional, Mathieu, C, additional, Mauricio, D, additional, Nordwall, M, additional, Van der Schueren, B, additional, Mandrup-Poulsen, T, additional, A Scherbaum, W, additional, Weets, I, additional, K Gorus, F, additional, Wareham, N, additional, D Leslie, R, additional, and Pozzilli, P, additional

Published
2015
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9. Age-dependent decline of beta-cell function in type 1 diabetes after diagnosis: a multi-centre longitudinal study

Author

Barker, A., Lauria, A., Schloot, N., Hosszufalusi, N., Ludvigsson, J., Mathieu, C., Mauricio, D., Nordwall, M., Van der Schueren, B., Mandrup-Poulsen, Thomas, Scherbaum, W. A., Weets, I., Gorus, F. K., Wareham, N., Leslie, R. D., Pozzilli, P., Barker, A., Lauria, A., Schloot, N., Hosszufalusi, N., Ludvigsson, J., Mathieu, C., Mauricio, D., Nordwall, M., Van der Schueren, B., Mandrup-Poulsen, Thomas, Scherbaum, W. A., Weets, I., Gorus, F. K., Wareham, N., Leslie, R. D., and Pozzilli, P.

Published
2014

10. Age-dependent decline of β cell function in type 1 diabetes after diagnosis:a multi-centre longitudinal study

Author

Barker, Vincent A., Lauria, A, Schloot, N, Hosszufalusi, N, Ludvigsson, J, Mathieu, Christopher John, Mauricio, D, Nordwall, M, Van der Schueren, B, Mandrup-Poulsen, Thomas, Scherbaum, Wa, Weets, I, Gorus, Fk, Wareham, N, Leslie, Rd, Pozzilli, P, Barker, Vincent A., Lauria, A, Schloot, N, Hosszufalusi, N, Ludvigsson, J, Mathieu, Christopher John, Mauricio, D, Nordwall, M, Van der Schueren, B, Mandrup-Poulsen, Thomas, Scherbaum, Wa, Weets, I, Gorus, Fk, Wareham, N, Leslie, Rd, and Pozzilli, P

Abstract

C-peptide secretion is currently the only available clinical biomarker to measure residual β-cell function in type 1 diabetes. However, the natural history of C-peptide decline after diagnosis can vary considerably dependent upon several variables. We investigated the shape of C-peptide decline over time from type 1 diabetes onset in relation to age at diagnosis, HbA1c levels and insulin dose.

Published
2013

11. Update on transcobalamin deficiency: clinical presentation, treatment and outcome

Author

Trakadis, Y. J., primary, Alfares, A., additional, Bodamer, O. A., additional, Buyukavci, M., additional, Christodoulou, J., additional, Connor, P., additional, Glamuzina, E., additional, Gonzalez-Fernandez, F., additional, Bibi, H., additional, Echenne, B., additional, Manoli, I., additional, Mitchell, J., additional, Nordwall, M., additional, Prasad, C., additional, Scaglia, F., additional, Schiff, M., additional, Schrewe, B., additional, Touati, G., additional, Tchan, M. C., additional, Varet, B., additional, Venditti, C. P., additional, Zafeiriou, D., additional, Rupar, C. A., additional, Rosenblatt, D. S., additional, Watkins, D., additional, and Braverman, N., additional

Published
2013
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12. Age-dependent decline of β-cell function in type 1 diabetes after diagnosis: a multi-centre longitudinal study

Author

Barker, A., primary, Lauria, A., additional, Schloot, N., additional, Hosszufalusi, N., additional, Ludvigsson, J., additional, Mathieu, C., additional, Mauricio, D., additional, Nordwall, M., additional, Van der Schueren, B., additional, Mandrup-Poulsen, T., additional, Scherbaum, W. A., additional, Weets, I., additional, Gorus, F. K., additional, Wareham, N., additional, Leslie, R. D., additional, and Pozzilli, P., additional

Published
2013
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14. Good glycemic control remains crucial in prevention of late diabetic complications - the Linköping Diabetes Complications Study.

Author

Nordwall M, Arnqvist HJ, Bojestig M, and Ludvigsson J

Abstract

BACKGROUND: Several intervention studies have convincingly demonstrated the importance of good glycemic control to avoid long-term diabetic complications, but the importance of other risk factors remains controversial. We previously reported a markedly reduced incidence of severe retinopathy and nephropathy during the past decades in an unselected population of type 1 diabetes mellitus diagnosed in childhood. The aim of the present study was to analyze possible risk factors, which could explain the improved prognosis. METHODS: In this longitudinal population-based cohort study, we followed all 269 patients in whom type 1 diabetes mellitus was diagnosed in childhood 1961-1985 in a well-defined geographical area in Sweden. The patients were followed until the end of 1990 s. Multivariable regression models were used to analyze the importance of hemoglobin A1c (HbA(1c)), diabetes duration, blood pressure, cardiovascular risk factors and persisting C-peptide secretion for the development of diabetic retinopathy and nephropathy. RESULTS: Beside longer duration and higher HbA(1c), blood pressure and lipid values were higher and cardiovascular disease and smoking were more common in patients with severe complications. However, multivariable analysis abolished these associations. Diabetes duration and long-term HbA(1c) were the only significant independent risk factors for both retinopathy and nephropathy. The risk of overt nephropathy increased substantially when HbA(1c) was above 9.6% [Diabetes Control and Complications Trial (DCCT) corrected value], while the risk of severe retinopathy increased already when HbA(1c) exceeded 8.6%. CONCLUSION: In this unselected population, glycemic control was the only significant risk factor for the development of long-term complications. [ABSTRACT FROM AUTHOR]

Published
2009
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15. One Thousand Small-bowel Biopsies in Children A Single-Port versus a Double-Port Capsule.

Author

Högberg, L., Nordwall, M., and Stenhammar, L.

Subjects
*CELIAC disease in children, *FLUOROSCOPY, *DIAGNOSIS, INTESTINAL biopsy
Abstract

Background: Small-bowel biopsy is a well-established technique in the evaluation of children with intestinal malabsorption, e.g. coeliac disease. The biopsy is performed endoscopically or with a peroral capsule instrument. The aim of the present retrospective study was to compare the single-port Watson capsule with the double-port Storz capsule with regard to procedure and fluoroscopy time, complications and failure rate. Methods: All 1,078 peroral small-bowel biopsies performed at our department during 1989-99 were studied. In 387 of these, the Watson capsule was used and in the remaining 691 the Storz capsule. Median age of the children was 2.5 years. About one-third of the children were premedicated with the prokinetic drug cisapride and as sedatives alimemazine or diazepam orally. Two-thirds of the children were given metoclopramide along with midazolam intravenously. The biopsies were performed under intermittent fluoroscopy. Results: The median biopsy procedure time was significantly shorter with the Storz capsule (7 min) compared to the Watson capsule (10 min) (P < 0.05). The median fluoroscopy time was 5 sec with the Storz capsule and 8 sec with the Watson capsule (P < 0.01). The failure rate did not differ significantly between the two capsule types: 10.3% (Watson) and 7.7% (Storz). One potential but no serious complication occurred. Conclusions: Providing that effective sedation is available, smallbowel biopsy with a peroral capsule, and the Storz double-port multibiopsy capsule in particular, is a safe and fast method exposing the child to a minimal radiation dose. [ABSTRACT FROM AUTHOR]

Published
2001

16. Age-dependent decline of beta-cell function in type 1 diabetes after diagnosis: a multi-centre longitudinal study

Author

Ak Barker, Lauria, A., Schloot, N. C., Hosszufalusi, N., Ludvigsson, J., Mathieu, C., Mauricio, D., Nordwall, M., Bart Van Der Schueren, Thomas Mandrup-Poulsen, Wa Scherbaum, Ilse Weets, Frans Gorus, Wareham, N., Rd Leslie, Pozzilli, P., Medical Biochemistry, Pathologic Biochemistry and Physiology, and Diabetes Pathology & Therapy

Subjects
diabetes, beta cell
Abstract

Aims C-peptide secretion is currently the only available clinical biomarker to measure residual ?-cell function in type 1 diabetes. However, the natural history of C-peptide decline after diagnosis can vary considerably dependent upon several variables. We investigated the shape of C-peptide decline over time from type 1 diabetes onset in relation to age at diagnosis, haemoglobin A1c (HbA1c) levels and insulin dose. Methods We analysed data from 3929 type 1 diabetes patients recruited from seven European centres representing all age groups at disease onset (childhood, adolescence and adulthood). The influence of the age at onset on ?-cell function was investigated in a longitudinal analysis at diagnosis and up to 5-years follow-up. Results Fasting C-peptide (FCP) data at diagnosis were available in 3668 patients stratified according to age at diagnosis in four groups (5?years?10?years?18?years, n?=?1655). FCP levels were positively correlated with age (p? Conclusions This study reveals a positive correlation between age at diagnosis of type 1 diabetes and FCP with a more rapid decline of ?-cell function in the very young patients. These data can inform the design of clinical trials using C-peptide values as an end-point for the effect of a given treatment.

17. Early increase in HbA1c trajectory predicts development of severe microangiopathy in patients with type 1 diabetes: the VISS study.

Author

Arnqvist HJ, Ludvigsson J, and Nordwall M

Subjects
Humans, Female, Male, Adult, Adolescent, Young Adult, Follow-Up Studies, Child, Diabetic Retinopathy epidemiology, Diabetic Retinopathy etiology, Prognosis, Biomarkers blood, Albuminuria epidemiology, Risk Factors, Child, Preschool, Diabetic Nephropathies epidemiology, Diabetic Nephropathies etiology, Disease Progression, Severity of Illness Index, Diabetes Mellitus, Type 1 complications, Diabetes Mellitus, Type 1 epidemiology, Glycated Hemoglobin analysis, Diabetic Angiopathies epidemiology, Diabetic Angiopathies etiology
Abstract

Introduction: To study the HbA1c trajectory from the time of diagnosis to examine if patients at the greatest risk for severe microangiopathy can be identified early allowing clinicians to intervene as soon as possible to avoid complications., Research Design and Methods: In a population-based observational study, 447 patients diagnosed with type 1 diabetes before 35 years of age, 1983-1987, were followed from diagnosis until 2019. Mean HbA1c was calculated each year for each patient. Severe diabetic microangiopathy was defined as proliferative diabetic retinopathy (PDR) or macroalbuminuria (nephropathy)., Results: After 32 years, 27% had developed PDR and 8% macroalbuminuria. Patients with weighted HbA1c (wHbA1c); <57 mmol/mol; <7.4% did not develop PDR or macroalbuminuria. The HbA1c trajectories for patients developing PDR and macroalbuminuria follow separate courses early on and stay separated for 32 years during the follow-up. Patients without severe complications show an initial dip, after which HbA1c slowly increases. HbA1c in patients with severe complications directly rises to a high level within a few years. Mean HbA1c calculated for the period 5-8 years after diabetes onset strongly predicts the development of severe complications. Females with childhood-onset diabetes exhibit a high peak in HbA1c during adolescence associated with higher wHbA1c and higher prevalence of PDR., Conclusions: The HbA1c trajectory from diabetes onset shows that mean HbA1c for the period 5-8 years after diagnosis strongly predicts severe microangiopathy. Females with childhood-onset diabetes exhibit a high peak in HbA1c during adolescence associated with higher wHbA1c and a higher prevalence of PDR., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2024
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18. Impact of HbA1c Followed 32 Years From Diagnosis of Type 1 Diabetes on Development of Severe Retinopathy and Nephropathy: The VISS Study.

Author

Arnqvist HJ, Westerlund MC, Fredrikson M, Ludvigsson J, and Nordwall M

Subjects
Humans, Glycated Hemoglobin analysis, Quality of Life, Risk Factors, Follow-Up Studies, Diabetes Mellitus, Type 1 complications, Diabetic Retinopathy epidemiology, Diabetic Nephropathies etiology
Abstract

Objective: To evaluate HbA1c followed from diagnosis, as a predictor of severe microvascular complications (i.e., proliferative diabetic retinopathy [PDR] and nephropathy [macroalbuminuria])., Research Design and Methods: In a population-based observational study, 447 patients diagnosed with type 1 diabetes before 35 years of age from 1983 to 1987 in southeast Sweden were followed from diagnosis until 2019. Long-term weighted mean HbA1c (wHbA1c) was calculated by integrating the area under all HbA1c values. Complications were analyzed in relation to wHbA1c categorized into five levels., Results: After 32 years, 9% had no retinopathy, 64% non-PDR, and 27% PDR, and 83% had no microalbuminuria, 9% microalbuminuria, and 8% macroalbuminuria. Patients with near-normal wHbA1c did not develop PDR or macroalbuminuria. The lowest wHbA1c values associated with development of PDR and nephropathy (macroalbuminuria) were 7.3% (56 mmol/mol) and 8.1% (65 mmol/mol), respectively. The prevalence of PDR and macroalbuminuria increased with increasing wHbA1c, being 74% and 44% in the highest category, wHbA1c >9.5% (>80 mmol/mol). In comparison with the follow-up done after 20-24 years' duration, the prevalence of PDR had increased from 14 to 27% and macroalbuminuria from 4 to 8%, and both appeared at lower wHbA1c values., Conclusions: wHbA1c followed from diagnosis is a very strong biomarker for PDR and nephropathy, the prevalence of both still increasing 32 years after diagnosis. To avoid PDR and macroalbuminuria in patients with type 1 diabetes, an HbA1c <7.0% (53 mmol/mol) and as normal as possible should be recommended when achievable without severe hypoglycemia and with good quality of life., (© 2022 by the American Diabetes Association.)

Published
2022
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19. Impact of Age of Onset, Puberty, and Glycemic Control Followed From Diagnosis on Incidence of Retinopathy in Type 1 Diabetes: The VISS Study.

Author

Nordwall M, Fredriksson M, Ludvigsson J, and Arnqvist HJ

Subjects
Adolescent, Adult, Blood Glucose, Diabetic Retinopathy epidemiology, Diabetic Retinopathy etiology, Diagnostic Techniques, Ophthalmological, Female, Glycated Hemoglobin analysis, Humans, Incidence, Male, Risk Factors, Sexual Maturation, Sweden epidemiology, Time Factors, Vitreoretinopathy, Proliferative, Young Adult, Diabetes Mellitus, Type 1 complications, Diabetic Retinopathy drug therapy, Hypoglycemic Agents therapeutic use
Abstract

Objective: To evaluate sex, age at diabetes onset, puberty, and HbA 1c , with subjects followed from diabetes diagnosis and during different time periods, as risk factors for developing diabetic simplex and proliferative retinopathy., Research Design and Methods: In a population-based observational study, HbA 1c for 451 patients diagnosed with diabetes before 35 years of age during 1983-1987 in southeast Sweden was followed for up to 18-24 years from diagnosis. Long-term mean weighted HbA 1c (wHbA 1c ) was calculated. Retinopathy was evaluated by fundus photography and analyzed in relation to wHbA 1c levels., Results: Lower wHbA 1c , diabetes onset ≤5 years of age, and diabetes onset before puberty, but not sex, were associated with longer time to appearance of simplex retinopathy. Proliferative retinopathy was associated only with wHbA 1c . The time to first appearance of any retinopathy decreased with increasing wHbA 1c . Lower wHbA 1c after ≤5 years' diabetes duration was associated with later onset of simplex retinopathy but not proliferative retinopathy. With time, most patients developed simplex retinopathy, except for those of the category wHbA 1c ≤50 mmol/mol (6.7%), for which 20 of 36 patients were without any retinopathy at the end of the follow-up in contrast to none of 49 with wHbA 1c >80 mmol/mol (9.5%)., Conclusions: Onset at ≤5 years of age and lower wHbA 1c the first 5 years after diagnosis are associated with longer duration before development of simplex retinopathy. There is a strong positive association between long-term mean HbA 1c measured from diagnosis and up to 20 years and appearance of both simplex and proliferative retinopathy., (© 2019 by the American Diabetes Association.)

Published
2019
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20. Response to Comment on Nordwall et al. Impact of HbA1c, Followed From Onset of Type 1 Diabetes, on the Development of Severe Retinopathy and Nephropathy: The VISS Study (Vascular Diabetic Complications in Southeast Sweden). Diabetes Care 2015;38:308-315.

Author

Nordwall M, Abrahamsson M, Dhir M, Fredrikson M, Ludvigsson J, and Arnqvist HJ

Subjects
Female, Humans, Male, Diabetes Mellitus, Type 1 etiology, Diabetic Angiopathies etiology, Diabetic Nephropathies etiology, Diabetic Retinopathy etiology, Glycated Hemoglobin metabolism
Published
2015
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21. Impact of HbA1c, followed from onset of type 1 diabetes, on the development of severe retinopathy and nephropathy: the VISS Study (Vascular Diabetic Complications in Southeast Sweden).

Author

Nordwall M, Abrahamsson M, Dhir M, Fredrikson M, Ludvigsson J, and Arnqvist HJ

Subjects
Adolescent, Adult, Aged, Child, Diabetes Mellitus, Type 1 blood, Diabetes Mellitus, Type 1 epidemiology, Diabetic Angiopathies blood, Diabetic Angiopathies epidemiology, Diabetic Nephropathies blood, Diabetic Nephropathies epidemiology, Diabetic Retinopathy blood, Diabetic Retinopathy epidemiology, Female, Follow-Up Studies, Humans, Incidence, Male, Middle Aged, Sweden epidemiology, Young Adult, Diabetes Mellitus, Type 1 etiology, Diabetic Angiopathies etiology, Diabetic Nephropathies etiology, Diabetic Retinopathy etiology, Glycated Hemoglobin metabolism
Abstract

Objective: HbA1c is strongly related to the development of diabetes complications, but it is still controversial which HbA1c level to strive for in the treatment of type 1 diabetes. The aim of the current study was to evaluate HbA1c, followed from diagnosis, as a predictor of severe microvascular complications and to formulate HbA1c target levels for treatment., Research Design and Methods: A longitudinal observation study followed an unselected population of 451 patients diagnosed with type 1 diabetes during 1983-1987 before the age of 35 years in a region of Southeast Sweden. Retinopathy was evaluated by fundus photography and nephropathy data collected from medical records. HbA1c was measured starting from diagnosis and during the whole follow-up period of 20-24 years. Long-term weighted mean HbA1c was then calculated. Complications were analyzed in relation to HbA1c levels., Results: The incidence of proliferative retinopathy and persistent macroalbuminuria increased sharply and occurred earlier with increasing long-term mean HbA1c. None of the 451 patients developed proliferative retinopathy or persistent macroalbuminuria below long-term weighted mean HbA1c 7.6% (60 mmol/mol); 51% of the patients with long-term mean HbA1c above 9.5% (80 mmol/mol) developed proliferative retinopathy and 23% persistent macroalbuminuria., Conclusions: Long-term weighted mean HbA1c, measured from diagnosis, is closely associated with the development of severe complications in type 1 diabetes. Keeping HbA1c below 7.6% (60 mmol/mol) as a treatment target seems to prevent proliferative retinopathy and persistent macroalbuminuria for up to 20 years., (© 2015 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.)

Published
2015
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22. Family-based behavioural intervention program for obese children: an observational study of child and parent lifestyle interpretations.

Author

Teder M, Mörelius E, Nordwall M, Bolme P, Ekberg J, Wilhelm E, and Timpka T

Subjects
Body Mass Index, Child, Eating, Exercise, Female, Humans, Hunger, Male, Parents, Treatment Outcome, Behavior Therapy, Feeding Behavior, Pediatric Obesity therapy
Abstract

Background: Family-based behavioural intervention programs (FBIPs) against childhood obesity have shown promising results, but the mediating mechanisms have not been identified. The aim of this study was to examine changes in obese childreńs lifestyle habits during a 2-year FBIP according to their own and parents' reports, the concordance between these reports and the correlations to change in post-intervention z-BMI., Methods: An observational study of 26 children (8.3-12.0 years) and their parents participating in a 2-year FBIP was performed. Weight and height were measured from baseline to 12 months after the end of the program. Eating habits and physical- and sedentary activity were reported separately by children and parents. Data were analysed with regard to concordance between parents' and children's reports and association between the lifestyle reports and change in z-BMI at the study endpoint using descriptive statistics and parametric and non-parametric tests., Results: According to both children's and parents' reports, the level of physical activity among the children had increased after the intervention as well as the agreement between the informants' reports. According to the children, eating habits had improved, while the parents' reports showed an improvement only with regard to binge eating. The concordance between children and parents regarding eating habits was slight to fair also after the intervention. No statistically significant associations between changes in lifestyle reports and changes in z-BMI were observed., Conclusions: Child and parent reports of physical activity were found to converge and display an improvement in a 2-year FBIP, while the reports on eating habits showed a more refractory pattern. Changes in concordance and agreement between children and parents reports did not correlate with weight reduction. Further methods development and studies of the processes during family-based interventions against childhood obesity are warranted.

Published
2013
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23. As Facts and Chats Go Online, What Is Important for Adolescents with Type 1 Diabetes?

Author

Nordfeldt S, Angarne-Lindberg T, Nordwall M, Ekberg J, and Berterö C

Subjects
Adolescent, Child, Female, Focus Groups, Humans, Information Seeking Behavior, Internet, Male, Patient Education as Topic, Social Media, Social Networking, Surveys and Questionnaires, Diabetes Mellitus, Type 1 psychology, Psychology, Adolescent
Abstract

Background: Continued refinement of resources for patient information, education and support is needed. Considering the rapid development of new communication practices, the perspectives of young people themselves warrant more attention using a wide research focus. The purpose of this study was to understand information-seeking behaviours, Internet use and social networking online in adolescents with type 1 diabetes (T1DM). This applied to their everyday life, including the context of diabetes and their experiences and need of contact with T1DM peers., Methodology/principal Findings: Twenty-four adolescents aged 10-17 years with T1DM were recruited from a county hospital in the south-east of Sweden. Qualitative data were obtained using eight focus groups, wherein each participant engaged in a 60-90 minute video/audio-recorded session. The focus group data were transcribed and analysed using qualitative content analysis. Some demographic and medical information was also collected. The three main categories that were identified; Aspects of Security, Updating, and Plainness and their sub-categories gave significant information about how to enhance information retrieval and peer contacts related to T1DM. Regarding the persons' information-seeking behaviour, Internet use, and use of social media some differences could be identified depending on gender and age., Conclusions/significance: Sensitivity and adaptation to users' needs and expectations seem crucial in the development of future online resources for adolescents with T1DM. To start with, this could mean applying a wider range of already existing information and communication technologies. Health practitioners need to focus on the areas of security of information and communication, frequency of updating, and simplicity of design-less is more.

Published
2013
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24. Parents of adolescents with type 1 diabetes--their views on information and communication needs and internet use. A qualitative study.

Author

Nordfeldt S, Ängarne-Lindberg T, Nordwall M, and Krevers B

Subjects
Adolescent, Adult, Child, Female, Focus Groups, Humans, Male, Middle Aged, Qualitative Research, Surveys and Questionnaires, Sweden, Diabetes Mellitus, Type 1, Information Seeking Behavior, Internet, Parents psychology
Abstract

Background: Little is known about parents' views on the use of online resources for information, education and support regarding childhood type 1 diabetes (T1DM). Considering the rapidly evolving new communication practices, parents' perspectives need to be explored. The main purpose of this paper was to explore parents' perceptions of their information-seeking, Internet use, and social networking online. This applied to their everyday life, including the contexts of T1DM and contact with peers. A second aim was to identify implications for future development of Internet use in this respect., Methodology/principal Findings: Twenty-seven parents of 24 young persons aged 10-17 with T1DM participated in eight focus group interviews during their regular visits to a county hospital. Focus group discussions were video/audio-taped, transcribed and analysed using inductive qualitative content analysis. Self-reported demographic and medical information was also collected. A main theme was Finding things out, including two sub-themes, Trust and Suitability. The latter were key factors affecting parents' perceptions of online resources. Parents' choice of information source was related to the situation, previous experiences and knowledge about sources and, most importantly, the level of trust in the source. A constantly present background theme was Life situation, including two sub-themes, Roles and functions and Emotions and needs. Parents' information-seeking regarding T1DM varied greatly, and was closely associated with their life situation, the adolescents development phases and the disease trajectory., Conclusions/significance: Health practitioners and system developers need to focus on creating trust and suitability for users' needs. They should understand the children's diverse needs, which depend on their life situation, on the children's development, and on the disease trajectory. To enhance trust in online health information and support services, the participation of local practitioners is crucial.

Published
2013
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25. Long-term clinical outcome after Lyme neuroborreliosis in childhood.

Author

Skogman BH, Glimåker K, Nordwall M, Vrethem M, Ödkvist L, and Forsberg P

Subjects
Achievement, Activities of Daily Living classification, Adolescent, Case-Control Studies, Child, Child, Preschool, Facial Paralysis diagnosis, Female, Follow-Up Studies, Humans, Infant, Male, Postural Balance, Recovery of Function, Surveys and Questionnaires, Vestibular Diseases diagnosis, Lyme Neuroborreliosis diagnosis, Nervous System Diseases diagnosis, Neurologic Examination, Sensation Disorders diagnosis
Abstract

Objectives: To determine long-term clinical outcome in children with confirmed Lyme neuroborreliosis (LNB) and to evaluate persistent subjective symptoms compared with a control group., Methods: After a median of 5 years, 84 children with confirmed LNB underwent a neurologic re-examination, including a questionnaire. Medical records were analyzed, and a control group (n = 84) was included., Results: The total recovery rate was 73% (n = 61). Objective neurologic findings, defined as "definite sequelae," were found in 16 patients (19%). The majority of these children had persistent facial nerve palsy (n = 11), but other motor or sensory deficits occurred (n = 5). Neurologic signs and/or symptoms defined as "possible sequelae" were found in another 7 patients (8%), mainly of sensory character. Nonspecific subjective symptoms were reported by 35 patients (42%) and 32 controls (38%) (nonsignificant). Affected daily activities or school performance were reported to the same extent in both groups (23% vs 20%, nonsignificant)., Conclusions: The long-term clinical recovery rate was 73% in children with confirmed LNB. Persistent facial nerve palsy occurred in 13%, whereas other motor or sensory deficits were found in another 14%. Neurologic deficits did not affect daily activities or school performance more often among patients than controls and should be considered as mild. Furthermore, nonspecific subjective symptoms such as headache, fatigue, or memory or concentration problems were reported as often among patients as controls and should not be considered as sequelae after LNB.

Published
2012
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26. Family-based behavioural intervention programme for obese children: a feasibility study.

Author

Teder M, Mörelius E, Bolme P, Nordwall M, Ekberg J, and Timpka T

Abstract

Objectives: To assess a 2-year family-based behavioural intervention programme against child obesity., Design: Single-group pre- and post-intervention feasibility study., Setting: Swedish paediatric outpatient care., Participants: 26 obese children aged 8.3-12.0 years and their parents who had consented to actively participate in a 2-year intervention., Interventions: 25 paediatric outpatient group sessions over a 2-year period with parallel groups for children and parents. The basis for the programme was a manual containing instructions for tutor-supervised group sessions with obese children and their parents., Primary and Secondary Outcome Measures: The primary outcome measure was change in standardised body mass index between baseline and after 36 months. The secondary outcome measures were change in the waist:height ratio, metabolic parameters and programme adherence. The participants were examined at baseline and after 3, 12 and 24 months of therapy and at follow-up 12 months after completion of the programme., Results: The primary outcome measure, standardised body mass index, declined from a mean of 3.3 (0.7 SD) at baseline to 2.9 (0.7 SD) (p<0.001) at follow-up 12 months after completion of the programme. There was no change in the waist:height ratio. Biomedical markers of blood glucose metabolism and lipid status remained in the normal range. 96% of the families completed the programme., Conclusions: This feasibility study of a 2-year family-based behavioural intervention programme in paediatric outpatient care showed promising results with regard to further weight gain and programme adherence. These findings must be confirmed in a randomised controlled trial with longer follow-up before the intervention programme can be implemented on a larger scale.

Published
2012
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27. Transcobalamin deficiency caused by compound heterozygosity for two novel mutations in the TCN2 gene: a study of two affected siblings, their brother, and their parents.

Author

Nissen PH, Nordwall M, Hoffmann-Lücke E, Sorensen BS, and Nexo E

Subjects
Adult, Base Sequence, Biomarkers blood, Child, Preschool, Computational Biology, DNA Mutational Analysis, Exons, Female, Genetic Predisposition to Disease, Genetic Testing methods, Heredity, Humans, Infant, Infant, Newborn, Male, Metabolism, Inborn Errors blood, Metabolism, Inborn Errors diagnosis, Molecular Sequence Data, Nonsense Mediated mRNA Decay, Pedigree, Phenotype, RNA, Messenger metabolism, Gene Deletion, Heterozygote, Metabolism, Inborn Errors genetics, Parents, Siblings, Transcobalamins deficiency, Transcobalamins genetics
Abstract

Transcobalamin (TC) deficiency (OMIM# 275350) is a rare, autosomal recessive disorder that presents in early infancy with a broad spectrum of symptoms, including failure to thrive, megaloblastic anemia, immunological deficiency, and neurological symptoms. Here we report a study of a family (parents and three children) with two children suffering from TC deficiency caused by two different mutations in the TCN2 gene. Initially, molecular genetic analysis of genomic DNA revealed a heterozygous mutation in the +1 position of exon 7 (c.1106+1 G > A) in the father and all three children. Bioinformatic analysis indicates that this mutation causes exon skipping, and further experiments supported this hypothesis and suggested that the mutant allele undergoes nonsense-mediated messenger RNA (mRNA) decay. We did not identify further mutations in genomic DNA that could explain TC deficiency in the two children. However, further efforts using complementary DNA (cDNA) derived from RNA from blood leukocytes identified a large deletion removing the entire exon 8, resulting in a frameshift and a premature stop codon (p.E371fsX372) in the mother and the two affected children. Our data indicate that if exon-by-exon DNA sequencing of genomic DNA does not uncover mutations corresponding to the phenotype, a systematic search for other mutations should be initiated by sequencing cDNA or using semiquantitative methods to detect large deletions in TCN2.

Published
2010
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28. Lyme neuroborreliosis in children: a prospective study of clinical features, prognosis, and outcome.

Author

Skogman BH, Croner S, Nordwall M, Eknefelt M, Ernerudh J, and Forsberg P

Subjects
Adolescent, Anti-Bacterial Agents therapeutic use, Borrelia burgdorferi immunology, Ceftriaxone therapeutic use, Child, Child, Preschool, Doxycycline therapeutic use, Enzyme-Linked Immunosorbent Assay, Facial Paralysis etiology, Female, Humans, Immunoglobulin M cerebrospinal fluid, Immunoglobulin M immunology, Leukocytosis cerebrospinal fluid, Lyme Neuroborreliosis cerebrospinal fluid, Lyme Neuroborreliosis complications, Lyme Neuroborreliosis drug therapy, Lyme Neuroborreliosis immunology, Male, Prognosis, Prospective Studies, Statistics, Nonparametric, Sweden, Treatment Outcome, Lyme Neuroborreliosis diagnosis
Abstract

Background: Evaluation of children with clinically suspected neuroborreliosis (NB) is difficult. With a prospective study design we wanted to characterize children with signs and symptoms indicative for NB, investigate clinical outcome and, if possible, identify factors of importance for recovery., Material/methods: Children being evaluated for NB (n = 177) in southeast Sweden were categorized into 3 groups: "confirmed neuroborreliosis" (41%) with Borrelia antibodies in the cerebrospinal fluid, "possible neuroborreliosis" (26%) with pleocytosis but no Borrelia antibodies in the cerebrospinal fluid, and "not determined" (33%) with no pleocytosis and no Borrelia antibodies in the cerebrospinal fluid. Antibiotic treatment was given to 69% of children. Patients were followed during 6 months and compared with a matched control group (n = 174)., Results: Clinical recovery at the 6-month follow-up (n = 177) was generally good and no patient was found to have recurrent or progressive neurologic symptoms. However, persistent facial nerve palsy caused dysfunctional and cosmetic problems in 11% of patients. Persistent nonspecific symptoms, such as headache and fatigue, were not more frequently reported in patients than in controls. Influence on daily life was reported to the same extent in patients and controls. Consequently, persistent headache and fatigue at follow-up should not be considered as attributable to NB. No prognostic factors could be identified., Conclusions: Clinical recovery was satisfactory in children being evaluated for NB although persistent symptoms from facial nerve palsy occurred. Persistent nonspecific symptoms, such as headache and fatigue, were not more frequently reported in patients than in controls.

Published
2008
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29. Clinical manifestations and beta cell function in Swedish diabetic children have remained unchanged during the last 25 years.

Author

Nordwall M and Ludvigsson J

Subjects
Adolescent, Age of Onset, Body Mass Index, C-Peptide blood, Child, Diabetes Mellitus, Type 1 drug therapy, Female, Humans, Hypoglycemic Agents therapeutic use, Incidence, Insulin therapeutic use, Male, Sweden epidemiology, Diabetes Mellitus, Type 1 epidemiology, Insulin-Secreting Cells physiology
Abstract

Background: The incidence of type 1 diabetes in childhood has doubled in Sweden during the last decades. Environmental factors may cause a different disease process, residual beta cell function and clinical manifestation. Insulin therapy has become more intensive. The aim of this study was to examine the clinical characteristics at onset, C-peptide secretion during the first years after diagnosis and if there was any secular trends during the last 25 years., Methods: All 316 children diagnosed with type 1 diabetes during 1976--2000 and living in the Linköping area were included. Information about clinical characteristics at diagnosis, duration of partial remission, insulin therapy at diagnosis and during the first years was collected from medical records. C-peptide secretion (fasting and stimulated) was measured regularly during the first 5 years. For analysis, the population was divided in five cohorts according to the year of diagnosis., Results: The clinical characteristics at onset were unchanged as well as duration of partial remission. C-peptide secretion was highest after 3 months and then declined gradually. After 5 years 32.7% of the patients had measurable fasting C-peptide, but only 6.5% > 0.1 nmol/L. HbA1c and insulin doses were lower in patients with persistent fasting C-peptide secretion > 0.1 nmol/L. The cohort 1996--2000 had higher stimulated C-peptide secretion at diagnosis and at 3 months, after longer follow-up there was no difference., Conclusion: The clinical characteristics at diagnosis, partial remission and duration of C-peptide secretion have remained largely unchanged for the last 25 years.

Published
2008
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30. Survey on the involvement of consumers in health technology assessment programs.

Author

Hailey D and Nordwall M

Subjects
Community Participation trends, Health Care Surveys, Health Personnel statistics & numerical data, Humans, Surveys and Questionnaires, Technology Assessment, Biomedical organization & administration, Community Participation methods, Technology Assessment, Biomedical methods
Abstract

Objectives: The aim of this study was to obtain information from members of the International Network of Agencies for Health Technology Assessment (INAHTA) on their involvement of consumers (patients, carers, and related organizations) in their programs., Methods: A questionnaire for a survey was developed and sent to member agencies in October 2005., Results: Of the thirty-seven agencies that provided responses, 57 percent involve consumers in some aspects of their HTA programs and 83 percent intend to involve consumers in the future. Summaries of HTA reports that are intended to be easily understood by consumers are prepared by 49 percent of the agencies, and 36 percent involve consumers in dissemination of HTA material., Conclusions: Most INAHTA members involve consumers in some aspects of their programs, although not always routinely. Involvement seems likely to increase in the future.

Published
2006
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31. Early diabetic complications in a population of young patients with type 1 diabetes mellitus despite intensive treatment.

Author

Nordwall M, Hyllienmark L, and Ludvigsson J

Subjects
Adolescent, Analysis of Variance, Child, Child, Preschool, Cohort Studies, Diabetes Complications epidemiology, Diabetes Mellitus, Type 1 blood, Diabetes Mellitus, Type 1 epidemiology, Diabetes Mellitus, Type 1 therapy, Diabetic Angiopathies epidemiology, Diabetic Angiopathies prevention & control, Diabetic Nephropathies prevention & control, Diabetic Neuropathies prevention & control, Diabetic Retinopathy prevention & control, Glycated Hemoglobin analysis, Humans, Infant, Insulin therapeutic use, Neural Conduction, Prevalence, Retrospective Studies, Statistics, Nonparametric, Sweden epidemiology, Albuminuria epidemiology, Diabetic Nephropathies epidemiology, Diabetic Neuropathies epidemiology, Diabetic Retinopathy epidemiology
Abstract

Aim: To describe the prevalence of early complications in an unselected population of patients with type 1 diabetes mellitus (DM1) diagnosed in childhood with intensive insulin treatment from diagnosis., Methods: Eighty children and adolescents with DM1, age 7-22 years and DM1 duration >3 years, were studied. Neuropathy was defined as abnormal nerve conduction finding in > or = 2 of 4 nerves (sural and peroneal nerves), nephropathy as albumin excretion rate > or = 20 microg/min and retinopathy as all grades of retinal changes in fundus photographs., Results: The prevalence of neuropathy was 59%, of retinopathy 27% and of nephropathy 5% after 13 years DM1 duration. Mean (SD) long-term HbA1c was 8.4 (0.9)% (DCCT-corrected value)., Conclusion: Even in a population with intensive insulin treatment from the beginning and fairly good metabolic control, the prevalence of subclinical neuropathy was high, while other diabetic complications were lower than usually reported.

Published
2006
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32. Up-regulation of Borrelia-specific IL-4- and IFN-gamma-secreting cells in cerebrospinal fluid from children with Lyme neuroborreliosis.

Author

Widhe M, Skogman BH, Jarefors S, Eknefelt M, Eneström G, Nordwall M, Ekerfelt C, Croner S, Bergström S, Forsberg P, and Ernerudh J

Subjects
Adolescent, Adult, Child, Child, Preschool, Female, Humans, Infant, Lyme Neuroborreliosis pathology, Lymphocyte Count, Lymphocytes immunology, Lymphocytes metabolism, Male, Prospective Studies, Borrelia burgdorferi immunology, Interferon-gamma metabolism, Interleukin-4 metabolism, Lyme Neuroborreliosis cerebrospinal fluid, Lyme Neuroborreliosis immunology, Up-Regulation immunology
Abstract

The clinical course and outcome of several infectious diseases are dependent on the type of immune response elicited against the pathogen. In adults with neuroborreliosis (NB), a type 1 response with high production of Borrelia-specific IFN-gamma, but no IL-4, has been reported. Since children have a more benign course of NB than adults, we wanted to investigate type 1 and type 2 responses in children with NB. Cerebrospinal fluid (CSF) and blood were collected from children during the acute stage of 'confirmed NB' (n = 34), 'possible NB' (n = 30) and 'non-NB' (n = 10). The number of Borrelia-specific IL-4- and IFN-gamma-secreting cells was measured by enzyme-linked immunospot assay. Borrelia-specific secretion of both IL-4 and IFN-gamma was increased in CSF in confirmed (P < 0.05) and possible (P < 0.01) NB, when compared with non-NB controls. Furthermore, children with NB had significantly higher Borrelia-specific IL-4 secretion in CSF than an adult reference material with NB (P < 0.05). There were no differences in cytokine secretion in relation to onset or recovery of neurological symptoms. Since IL-4 is known to down-regulate the pro-inflammatory and possibly harmful effects of prolonged IFN-gamma responses, the prominent IL-4 response observed in the central nervous system compartment might contribute to the more benign disease course seen in children with Lyme NB.

Published
2005
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33. Moderate Dose Inhaled Budesonide Disguising Symptoms of Addison's Disease in An Asthmatic Boy with Silent Celiac Disease.

Author

Stenhammar LC, Högberg LM, Nordwall M, and Strömberg LG

Abstract

Inhaled corticosteroids are first-line treatment for asthma. Moderate doses of budesonide have been supposed not to affect hypothalamic-pituitary-adrenal axis function. We report the case of a boy with asthmatic symptoms and a late diagnosis of celiac disease, in whom inhaled budesonide in a dose used in conventional asthma therapy seems to have been systemically absorbed in amounts large enough to temporarily disguise the symptoms of a developing adrenal insufficiency. Inhaled corticosteroids in a dose used in standard asthma therapy seem to have the potential of disguising a developing Addison's disease. Furthermore, celiac disease, especially if diagnosed in late childhood, may be associated with Addison's disease causing a complex symptom pattern.

Published
2005
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