Treatment options for type 2 diabetes in adolescents and youth: A study of the comparative efficacy of metformin alone or in combination with rosiglitazone or lifestyle intervention in adolescents with type 2 diabetes

M. Haymond, B. Anderson, P. Barrera, P. Brosnan, C. Bush, T. Green, H. Holden, G. Jeha, M. Jones, S. McGirk, S. McKay, D. Miller, B. Schreiner, M. Zarate, W. Dahms, T. Casey, L. Cuttler, D. Drotar, E. Frieson, C. Levers-LandisP. McGuigan, M. Palmert, S. Sundararajan, D. Witherspoon, M. Geffner, N. Chang, D. Dreimane, S. Estrada, J. Fabian, M. Halvorson, B. Hollen, F. Kaufman, C. Munoz, A. Ward, P. Yasuda, L. Katz, R. Allegretto, C. Carchidi, J. Kaplan, C. Lassiter, S. Magge, S. Sababu, B. Schwartzman, S. Willi, S. Arslanian, F. Bacha, S. Foster, Tamara Hannon, K. Kolenc, A. Kriska, I. Libman, M. Marcus, D. Rofey, P. Scanlon, T. Songer, E. Venditti, V. Weisbrod, R. Goland, J. Belle, R. Cain, P. Kringas, N. Leibel, D. Ng, M. Ovalles, K. Robbins, D. Seidman, L. Siegel-Czarkowski, D. Nathan, L. Laffel, A. Angelescou, L. Bissett, C. Ciccarelli, K. Corrales-Yauckoes, L. Delahanty, A. Goebel-Fabbri, V. Goldman, L. Higgins, K. Hood, M. Larkin, M. Lee, L. Levitsky, M. Malloy, R. McEachern, K. Milaszewski, D. Norman, B. Nwosu, L. Orkin, S. Park-Bennett, D. Richards, A. Rodriguez-Ventura, M. Sheehy, L. Soyka, B. Steiner, R. Weinstock, D. Bowerman, K. Bratt, S. Carusone, S. Doolittle

Research output: Contribution to journalArticle

156 Citations (Scopus)

Abstract

Despite the increased prevalence of type 2 diabetes mellitus (T2DM) in the pediatric population, there is limited information about the relative effectiveness of treatment approaches. This article describes the rationale and design of a National Institutes of Health-sponsored multi-site, randomized, parallel group clinical trial designed to test the hypothesis that aggressive reduction in insulin resistance early in the course of T2DM is beneficial for prolongation of glycemic control, as well as improvement in associated abnormalities and risk factors. Specifically, the trial compares treatment with metformin with two alternate approaches, one pharmacologic (combining metformin treatment with rosiglitazone) and one combining metformin with an intensive lifestyle intervention program. The Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study recruits 800 patients over a 4-yr period and follows them for a minimum of 2 yr and maximum of 6 yr. Patients are 10-17 yr of age, within 2 yr of diagnosis of diabetes at the time of randomization, lack evidence of autoimmunity, and have sustained C-peptide secretion. The primary outcome is time to loss of glycemic control, defined as a hemoglobin A1c >8% for 6 consecutive months. Secondary outcomes include the effect of the alternative treatments on insulin secretion and resistance, body composition, nutrition, physical activity and fitness, cardiovascular risk monitoring, microvascular complications, quality of life, depression, eating pathology, and resource utilization. TODAY is the first large-scale, systematic study of treatment effectiveness for T2DM in youth. When successfully completed, this study will provide critical new information regarding the natural history of T2DM in youth, the benefits of initiating early aggressive treatment in these patients, and the efficacy of delivering an intensive and sustained lifestyle intervention to children with T2DM.

Original languageEnglish (US)
Pages (from-to)74-87
Number of pages14
JournalPediatric Diabetes
Volume8
Issue number2
DOIs
StatePublished - Apr 2007
Externally publishedYes

Fingerprint

rosiglitazone
Metformin
Type 2 Diabetes Mellitus
Life Style
Therapeutics
Insulin Resistance
Physical Fitness
C-Peptide
National Institutes of Health (U.S.)
Random Allocation
Body Composition
Autoimmunity
Hemoglobins

Keywords

  • Adolescents
  • Lifestyle change
  • Metformin
  • Obesity
  • Thiazolidinedione
  • Type 2 diabetes

ASJC Scopus subject areas

  • Internal Medicine
  • Pediatrics, Perinatology, and Child Health
  • Endocrinology, Diabetes and Metabolism

Cite this

Treatment options for type 2 diabetes in adolescents and youth : A study of the comparative efficacy of metformin alone or in combination with rosiglitazone or lifestyle intervention in adolescents with type 2 diabetes. / Haymond, M.; Anderson, B.; Barrera, P.; Brosnan, P.; Bush, C.; Green, T.; Holden, H.; Jeha, G.; Jones, M.; McGirk, S.; McKay, S.; Miller, D.; Schreiner, B.; Zarate, M.; Dahms, W.; Casey, T.; Cuttler, L.; Drotar, D.; Frieson, E.; Levers-Landis, C.; McGuigan, P.; Palmert, M.; Sundararajan, S.; Witherspoon, D.; Geffner, M.; Chang, N.; Dreimane, D.; Estrada, S.; Fabian, J.; Halvorson, M.; Hollen, B.; Kaufman, F.; Munoz, C.; Ward, A.; Yasuda, P.; Katz, L.; Allegretto, R.; Carchidi, C.; Kaplan, J.; Lassiter, C.; Magge, S.; Sababu, S.; Schwartzman, B.; Willi, S.; Arslanian, S.; Bacha, F.; Foster, S.; Hannon, Tamara; Kolenc, K.; Kriska, A.; Libman, I.; Marcus, M.; Rofey, D.; Scanlon, P.; Songer, T.; Venditti, E.; Weisbrod, V.; Goland, R.; Belle, J.; Cain, R.; Kringas, P.; Leibel, N.; Ng, D.; Ovalles, M.; Robbins, K.; Seidman, D.; Siegel-Czarkowski, L.; Nathan, D.; Laffel, L.; Angelescou, A.; Bissett, L.; Ciccarelli, C.; Corrales-Yauckoes, K.; Delahanty, L.; Goebel-Fabbri, A.; Goldman, V.; Higgins, L.; Hood, K.; Larkin, M.; Lee, M.; Levitsky, L.; Malloy, M.; McEachern, R.; Milaszewski, K.; Norman, D.; Nwosu, B.; Orkin, L.; Park-Bennett, S.; Richards, D.; Rodriguez-Ventura, A.; Sheehy, M.; Soyka, L.; Steiner, B.; Weinstock, R.; Bowerman, D.; Bratt, K.; Carusone, S.; Doolittle, S.

In: Pediatric Diabetes, Vol. 8, No. 2, 04.2007, p. 74-87.

Research output: Contribution to journalArticle

Haymond, M, Anderson, B, Barrera, P, Brosnan, P, Bush, C, Green, T, Holden, H, Jeha, G, Jones, M, McGirk, S, McKay, S, Miller, D, Schreiner, B, Zarate, M, Dahms, W, Casey, T, Cuttler, L, Drotar, D, Frieson, E, Levers-Landis, C, McGuigan, P, Palmert, M, Sundararajan, S, Witherspoon, D, Geffner, M, Chang, N, Dreimane, D, Estrada, S, Fabian, J, Halvorson, M, Hollen, B, Kaufman, F, Munoz, C, Ward, A, Yasuda, P, Katz, L, Allegretto, R, Carchidi, C, Kaplan, J, Lassiter, C, Magge, S, Sababu, S, Schwartzman, B, Willi, S, Arslanian, S, Bacha, F, Foster, S, Hannon, T, Kolenc, K, Kriska, A, Libman, I, Marcus, M, Rofey, D, Scanlon, P, Songer, T, Venditti, E, Weisbrod, V, Goland, R, Belle, J, Cain, R, Kringas, P, Leibel, N, Ng, D, Ovalles, M, Robbins, K, Seidman, D, Siegel-Czarkowski, L, Nathan, D, Laffel, L, Angelescou, A, Bissett, L, Ciccarelli, C, Corrales-Yauckoes, K, Delahanty, L, Goebel-Fabbri, A, Goldman, V, Higgins, L, Hood, K, Larkin, M, Lee, M, Levitsky, L, Malloy, M, McEachern, R, Milaszewski, K, Norman, D, Nwosu, B, Orkin, L, Park-Bennett, S, Richards, D, Rodriguez-Ventura, A, Sheehy, M, Soyka, L, Steiner, B, Weinstock, R, Bowerman, D, Bratt, K, Carusone, S & Doolittle, S 2007, 'Treatment options for type 2 diabetes in adolescents and youth: A study of the comparative efficacy of metformin alone or in combination with rosiglitazone or lifestyle intervention in adolescents with type 2 diabetes', Pediatric Diabetes, vol. 8, no. 2, pp. 74-87. https://doi.org/10.1111/j.1399-5448.2007.00237.x
Haymond, M. ; Anderson, B. ; Barrera, P. ; Brosnan, P. ; Bush, C. ; Green, T. ; Holden, H. ; Jeha, G. ; Jones, M. ; McGirk, S. ; McKay, S. ; Miller, D. ; Schreiner, B. ; Zarate, M. ; Dahms, W. ; Casey, T. ; Cuttler, L. ; Drotar, D. ; Frieson, E. ; Levers-Landis, C. ; McGuigan, P. ; Palmert, M. ; Sundararajan, S. ; Witherspoon, D. ; Geffner, M. ; Chang, N. ; Dreimane, D. ; Estrada, S. ; Fabian, J. ; Halvorson, M. ; Hollen, B. ; Kaufman, F. ; Munoz, C. ; Ward, A. ; Yasuda, P. ; Katz, L. ; Allegretto, R. ; Carchidi, C. ; Kaplan, J. ; Lassiter, C. ; Magge, S. ; Sababu, S. ; Schwartzman, B. ; Willi, S. ; Arslanian, S. ; Bacha, F. ; Foster, S. ; Hannon, Tamara ; Kolenc, K. ; Kriska, A. ; Libman, I. ; Marcus, M. ; Rofey, D. ; Scanlon, P. ; Songer, T. ; Venditti, E. ; Weisbrod, V. ; Goland, R. ; Belle, J. ; Cain, R. ; Kringas, P. ; Leibel, N. ; Ng, D. ; Ovalles, M. ; Robbins, K. ; Seidman, D. ; Siegel-Czarkowski, L. ; Nathan, D. ; Laffel, L. ; Angelescou, A. ; Bissett, L. ; Ciccarelli, C. ; Corrales-Yauckoes, K. ; Delahanty, L. ; Goebel-Fabbri, A. ; Goldman, V. ; Higgins, L. ; Hood, K. ; Larkin, M. ; Lee, M. ; Levitsky, L. ; Malloy, M. ; McEachern, R. ; Milaszewski, K. ; Norman, D. ; Nwosu, B. ; Orkin, L. ; Park-Bennett, S. ; Richards, D. ; Rodriguez-Ventura, A. ; Sheehy, M. ; Soyka, L. ; Steiner, B. ; Weinstock, R. ; Bowerman, D. ; Bratt, K. ; Carusone, S. ; Doolittle, S. / Treatment options for type 2 diabetes in adolescents and youth : A study of the comparative efficacy of metformin alone or in combination with rosiglitazone or lifestyle intervention in adolescents with type 2 diabetes. In: Pediatric Diabetes. 2007 ; Vol. 8, No. 2. pp. 74-87.
@article{95efacfb3ee343ed95c42ade929608d3,
title = "Treatment options for type 2 diabetes in adolescents and youth: A study of the comparative efficacy of metformin alone or in combination with rosiglitazone or lifestyle intervention in adolescents with type 2 diabetes",
abstract = "Despite the increased prevalence of type 2 diabetes mellitus (T2DM) in the pediatric population, there is limited information about the relative effectiveness of treatment approaches. This article describes the rationale and design of a National Institutes of Health-sponsored multi-site, randomized, parallel group clinical trial designed to test the hypothesis that aggressive reduction in insulin resistance early in the course of T2DM is beneficial for prolongation of glycemic control, as well as improvement in associated abnormalities and risk factors. Specifically, the trial compares treatment with metformin with two alternate approaches, one pharmacologic (combining metformin treatment with rosiglitazone) and one combining metformin with an intensive lifestyle intervention program. The Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study recruits 800 patients over a 4-yr period and follows them for a minimum of 2 yr and maximum of 6 yr. Patients are 10-17 yr of age, within 2 yr of diagnosis of diabetes at the time of randomization, lack evidence of autoimmunity, and have sustained C-peptide secretion. The primary outcome is time to loss of glycemic control, defined as a hemoglobin A1c >8{\%} for 6 consecutive months. Secondary outcomes include the effect of the alternative treatments on insulin secretion and resistance, body composition, nutrition, physical activity and fitness, cardiovascular risk monitoring, microvascular complications, quality of life, depression, eating pathology, and resource utilization. TODAY is the first large-scale, systematic study of treatment effectiveness for T2DM in youth. When successfully completed, this study will provide critical new information regarding the natural history of T2DM in youth, the benefits of initiating early aggressive treatment in these patients, and the efficacy of delivering an intensive and sustained lifestyle intervention to children with T2DM.",
keywords = "Adolescents, Lifestyle change, Metformin, Obesity, Thiazolidinedione, Type 2 diabetes",
author = "M. Haymond and B. Anderson and P. Barrera and P. Brosnan and C. Bush and T. Green and H. Holden and G. Jeha and M. Jones and S. McGirk and S. McKay and D. Miller and B. Schreiner and M. Zarate and W. Dahms and T. Casey and L. Cuttler and D. Drotar and E. Frieson and C. Levers-Landis and P. McGuigan and M. Palmert and S. Sundararajan and D. Witherspoon and M. Geffner and N. Chang and D. Dreimane and S. Estrada and J. Fabian and M. Halvorson and B. Hollen and F. Kaufman and C. Munoz and A. Ward and P. Yasuda and L. Katz and R. Allegretto and C. Carchidi and J. Kaplan and C. Lassiter and S. Magge and S. Sababu and B. Schwartzman and S. Willi and S. Arslanian and F. Bacha and S. Foster and Tamara Hannon and K. Kolenc and A. Kriska and I. Libman and M. Marcus and D. Rofey and P. Scanlon and T. Songer and E. Venditti and V. Weisbrod and R. Goland and J. Belle and R. Cain and P. Kringas and N. Leibel and D. Ng and M. Ovalles and K. Robbins and D. Seidman and L. Siegel-Czarkowski and D. Nathan and L. Laffel and A. Angelescou and L. Bissett and C. Ciccarelli and K. Corrales-Yauckoes and L. Delahanty and A. Goebel-Fabbri and V. Goldman and L. Higgins and K. Hood and M. Larkin and M. Lee and L. Levitsky and M. Malloy and R. McEachern and K. Milaszewski and D. Norman and B. Nwosu and L. Orkin and S. Park-Bennett and D. Richards and A. Rodriguez-Ventura and M. Sheehy and L. Soyka and B. Steiner and R. Weinstock and D. Bowerman and K. Bratt and S. Carusone and S. Doolittle",
year = "2007",
month = "4",
doi = "10.1111/j.1399-5448.2007.00237.x",
language = "English (US)",
volume = "8",
pages = "74--87",
journal = "Pediatric Diabetes",
issn = "1399-543X",
publisher = "Blackwell Munksgaard",
number = "2",

}

TY - JOUR

T1 - Treatment options for type 2 diabetes in adolescents and youth

T2 - A study of the comparative efficacy of metformin alone or in combination with rosiglitazone or lifestyle intervention in adolescents with type 2 diabetes

AU - Haymond, M.

AU - Anderson, B.

AU - Barrera, P.

AU - Brosnan, P.

AU - Bush, C.

AU - Green, T.

AU - Holden, H.

AU - Jeha, G.

AU - Jones, M.

AU - McGirk, S.

AU - McKay, S.

AU - Miller, D.

AU - Schreiner, B.

AU - Zarate, M.

AU - Dahms, W.

AU - Casey, T.

AU - Cuttler, L.

AU - Drotar, D.

AU - Frieson, E.

AU - Levers-Landis, C.

AU - McGuigan, P.

AU - Palmert, M.

AU - Sundararajan, S.

AU - Witherspoon, D.

AU - Geffner, M.

AU - Chang, N.

AU - Dreimane, D.

AU - Estrada, S.

AU - Fabian, J.

AU - Halvorson, M.

AU - Hollen, B.

AU - Kaufman, F.

AU - Munoz, C.

AU - Ward, A.

AU - Yasuda, P.

AU - Katz, L.

AU - Allegretto, R.

AU - Carchidi, C.

AU - Kaplan, J.

AU - Lassiter, C.

AU - Magge, S.

AU - Sababu, S.

AU - Schwartzman, B.

AU - Willi, S.

AU - Arslanian, S.

AU - Bacha, F.

AU - Foster, S.

AU - Hannon, Tamara

AU - Kolenc, K.

AU - Kriska, A.

AU - Libman, I.

AU - Marcus, M.

AU - Rofey, D.

AU - Scanlon, P.

AU - Songer, T.

AU - Venditti, E.

AU - Weisbrod, V.

AU - Goland, R.

AU - Belle, J.

AU - Cain, R.

AU - Kringas, P.

AU - Leibel, N.

AU - Ng, D.

AU - Ovalles, M.

AU - Robbins, K.

AU - Seidman, D.

AU - Siegel-Czarkowski, L.

AU - Nathan, D.

AU - Laffel, L.

AU - Angelescou, A.

AU - Bissett, L.

AU - Ciccarelli, C.

AU - Corrales-Yauckoes, K.

AU - Delahanty, L.

AU - Goebel-Fabbri, A.

AU - Goldman, V.

AU - Higgins, L.

AU - Hood, K.

AU - Larkin, M.

AU - Lee, M.

AU - Levitsky, L.

AU - Malloy, M.

AU - McEachern, R.

AU - Milaszewski, K.

AU - Norman, D.

AU - Nwosu, B.

AU - Orkin, L.

AU - Park-Bennett, S.

AU - Richards, D.

AU - Rodriguez-Ventura, A.

AU - Sheehy, M.

AU - Soyka, L.

AU - Steiner, B.

AU - Weinstock, R.

AU - Bowerman, D.

AU - Bratt, K.

AU - Carusone, S.

AU - Doolittle, S.

PY - 2007/4

Y1 - 2007/4

N2 - Despite the increased prevalence of type 2 diabetes mellitus (T2DM) in the pediatric population, there is limited information about the relative effectiveness of treatment approaches. This article describes the rationale and design of a National Institutes of Health-sponsored multi-site, randomized, parallel group clinical trial designed to test the hypothesis that aggressive reduction in insulin resistance early in the course of T2DM is beneficial for prolongation of glycemic control, as well as improvement in associated abnormalities and risk factors. Specifically, the trial compares treatment with metformin with two alternate approaches, one pharmacologic (combining metformin treatment with rosiglitazone) and one combining metformin with an intensive lifestyle intervention program. The Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study recruits 800 patients over a 4-yr period and follows them for a minimum of 2 yr and maximum of 6 yr. Patients are 10-17 yr of age, within 2 yr of diagnosis of diabetes at the time of randomization, lack evidence of autoimmunity, and have sustained C-peptide secretion. The primary outcome is time to loss of glycemic control, defined as a hemoglobin A1c >8% for 6 consecutive months. Secondary outcomes include the effect of the alternative treatments on insulin secretion and resistance, body composition, nutrition, physical activity and fitness, cardiovascular risk monitoring, microvascular complications, quality of life, depression, eating pathology, and resource utilization. TODAY is the first large-scale, systematic study of treatment effectiveness for T2DM in youth. When successfully completed, this study will provide critical new information regarding the natural history of T2DM in youth, the benefits of initiating early aggressive treatment in these patients, and the efficacy of delivering an intensive and sustained lifestyle intervention to children with T2DM.

AB - Despite the increased prevalence of type 2 diabetes mellitus (T2DM) in the pediatric population, there is limited information about the relative effectiveness of treatment approaches. This article describes the rationale and design of a National Institutes of Health-sponsored multi-site, randomized, parallel group clinical trial designed to test the hypothesis that aggressive reduction in insulin resistance early in the course of T2DM is beneficial for prolongation of glycemic control, as well as improvement in associated abnormalities and risk factors. Specifically, the trial compares treatment with metformin with two alternate approaches, one pharmacologic (combining metformin treatment with rosiglitazone) and one combining metformin with an intensive lifestyle intervention program. The Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study recruits 800 patients over a 4-yr period and follows them for a minimum of 2 yr and maximum of 6 yr. Patients are 10-17 yr of age, within 2 yr of diagnosis of diabetes at the time of randomization, lack evidence of autoimmunity, and have sustained C-peptide secretion. The primary outcome is time to loss of glycemic control, defined as a hemoglobin A1c >8% for 6 consecutive months. Secondary outcomes include the effect of the alternative treatments on insulin secretion and resistance, body composition, nutrition, physical activity and fitness, cardiovascular risk monitoring, microvascular complications, quality of life, depression, eating pathology, and resource utilization. TODAY is the first large-scale, systematic study of treatment effectiveness for T2DM in youth. When successfully completed, this study will provide critical new information regarding the natural history of T2DM in youth, the benefits of initiating early aggressive treatment in these patients, and the efficacy of delivering an intensive and sustained lifestyle intervention to children with T2DM.

KW - Adolescents

KW - Lifestyle change

KW - Metformin

KW - Obesity

KW - Thiazolidinedione

KW - Type 2 diabetes

UR - http://www.scopus.com/inward/record.url?scp=34247337661&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=34247337661&partnerID=8YFLogxK

U2 - 10.1111/j.1399-5448.2007.00237.x

DO - 10.1111/j.1399-5448.2007.00237.x

M3 - Article

C2 - 17448130

AN - SCOPUS:34247337661

VL - 8

SP - 74

EP - 87

JO - Pediatric Diabetes

JF - Pediatric Diabetes

SN - 1399-543X

IS - 2

ER -