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.

journal_name

Pediatr Diabetes

journal_title

Pediatric diabetes

authors

TODAY Study Group.,Zeitler P,Epstein L,Grey M,Hirst K,Kaufman F,Tamborlane W,Wilfley D

doi

10.1111/j.1399-5448.2007.00237.x

subject

Has Abstract

pub_date

2007-04-01 00:00:00

pages

74-87

issue

2

eissn

1399-543X

issn

1399-5448

pii

PDI237

journal_volume

8

pub_type

杂志文章,多中心研究,随机对照试验
  • Evaluation of a portable ambulatory prototype for automated overnight closed-loop insulin delivery in young people with type 1 diabetes.

    abstract:OBJECTIVE:To evaluate an ambulatory, portable prototype, overnight automated closed-loop (CL) system and to explore optimal time of CL initiation. METHODS:We performed a randomized crossover study and compared automated overnight glucose control started at the time of an evening-meal or at bedtime. Eight young people ...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章,随机对照试验

    doi:10.1111/j.1399-5448.2012.00903.x

    authors: Elleri D,Allen JM,Biagioni M,Kumareswaran K,Leelarathna L,Caldwell K,Nodale M,Wilinska ME,Acerini CL,Dunger DB,Hovorka R

    更新日期:2012-09-01 00:00:00

  • Infant anthropometry, early life infection, and subsequent risk of type 1 diabetes mellitus: a prospective birth cohort study.

    abstract:BACKGROUND:Higher birthweight is associated with increased type 1 diabetes mellitus (T1DM) risk, but the contribution of higher adiposity or lean mass is unclear. In this Tasmanian infant cohort, early upper respiratory infection has been associated with higher asthma risk. PATIENTS AND METHODS:Eligible infants repres...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章,多中心研究

    doi:10.1111/j.1399-5448.2010.00693.x

    authors: Ponsonby AL,Pezic A,Cochrane J,Cameron FJ,Pascoe M,Kemp A,Dwyer T

    更新日期:2011-06-01 00:00:00

  • Changes in body composition after a 12-wk aerobic exercise program in obese boys.

    abstract:UNLABELLED:Previous studies have shown that vigorous aerobic training programs for obese children result in minimal weight changes, and concluded that they may not be beneficial. Weight change alone may not detect important beneficial changes in body composition associated with vigorous training in these children. Fift...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1034/j.1399-5448.2000.010202.x

    authors: DeStefano RA,Caprio S,Fahey JT,Tamborlane WV,Goldberg B

    更新日期:2000-06-01 00:00:00

  • Management of cardiovascular disease risk in teens with type 1 diabetes: Perspectives of teens with and without dyslipidemia and parents.

    abstract::Hypertension and dyslipidemia are often suboptimally managed in teens with type 1 diabetes (T1D). Teen and parent perspectives on hypertension and dyslipidemia management need further study to enhance the development of cardiovascular disease (CVD) risk factor management plans. We sought to describe barriers to and st...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/pedi.12771

    authors: Katz ML,Guo Z,Cheema A,Laffel LM

    更新日期:2019-03-01 00:00:00

  • Improvement in glycemic control through changes in insulin regimens: findings from a Japanese cohort of children and adolescents with type 1 diabetes.

    abstract:OBJECTIVE:Although insulin analogs have dramatically changed diabetes treatment, scarce evidence is available on those effects. We aimed to explore whether glycemic control had improved, the use of insulin analogs had been increased, and hypoglycemic events had decreased over time in Japanese pediatric patients with ty...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/pedi.12409

    authors: Mochizuki M,Kikuchi T,Urakami T,Kikuchi N,Kawamura T,Yokomichi H,Hoshino T,Matsuura N,Sasaki N,Sugihara S,Amemiya S,Japanese Study Group of Insulin Therapy for Childhood Adolescent Diabetes (JSGIT).

    更新日期:2017-09-01 00:00:00

  • Twenty-one years of prospective incidence of childhood type 1 diabetes in Hungary--the rising trend continues (or peaks and highlands?).

    abstract::The aim of this study was to examine secular trends in the incidence of type 1 diabetes in children aged 0-14 yr in Hungary over the period 1989-2009. Newly diagnosed children with type 1 diabetes aged 0-14 yr in Hungary were prospectively registered from 1989 to 2009. Primary ascertainment of cases was by prospective...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/j.1399-5448.2011.00826.x

    authors: Gyurus EK,Patterson C,Soltesz G,Hungarian Childhood Diabetes Epidemiology Group.

    更新日期:2012-02-01 00:00:00

  • Intramyocellular lipid, adiposity, and muscle oxygen supply in prepubertal type 1 diabetes.

    abstract:BACKGROUND:In the non-diabetic population, intramyocellular lipid (IMCL) accumulation is associated with obesity and poor muscle oxygen supply. IMCL levels are increased in type 1 diabetes, but their significance is less clear. METHODS:We studied a group of 16 prepubertal boys (age 6.4-9.9 yr) with type 1 diabetes and...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1034/j.1399-5448.2003.00021.x

    authors: Ling AH,Donaghue KC,Howard NJ,Arrowsmith FE,Ward JA,Baur LA,Thompson CH

    更新日期:2003-09-01 00:00:00

  • Obesity and family history of diabetes as risk factors of impaired fasting glucose: implications for the early detection of prediabetes.

    abstract:OBJECTIVE:To determine whether the association between family history of diabetes (FHD) and impaired fasting glucose (IFG) is independent of body mass index (BMI) in children and adolescents. METHODS:In all 443 (11.9%) children and adolescents with FHD, and 3280 (88.1%) without FHD were enrolled in a population-based ...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/j.1399-5448.2009.00590.x

    authors: Rodríguez-Moran M,Guerrero-Romero F,Aradillas-García C,Violante R,Simental-Mendia LE,Monreal-Escalante E,Mendoza Ede L

    更新日期:2010-08-01 00:00:00

  • β-cell autoimmunity in overweight non-diabetic youth: any implications?

    abstract:BACKGROUND AND OBJECTIVE:The presence of β-cell antibodies is associated with a high risk of type 1 diabetes. With increasing rates of obesity, the distinction between obese T1DM and T2DM has become difficult. Moreover, increasing body mass index (BMI) in at-risk children has been proposed not only as a possible contri...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/j.1399-5448.2010.00697.x

    authors: Libman IM,Barinas-Mitchell E,Marcovina S,Bacha F,Hannon T,Tfayli H,Lee SJ,Bansal S,Robertson R,Arslanian S

    更新日期:2011-05-01 00:00:00

  • Long-term metabolic consequences of being born small for gestational age.

    abstract::This review highlights the evidence of linking small for gestational age (SGA) with metabolic/cardiovascular disturbances (dysmetabolic syndrome) in later life. The metabolic and cardiovascular complications associated with in utero undernutrition have been identified during the past 10 yr. Reduced fetal growth is ind...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章,评审

    doi:10.1111/j.1399-543X.2004.00057.x

    authors: Levy-Marchal C,Jaquet D

    更新日期:2004-09-01 00:00:00

  • Impaired beta-cell sensitivity to glucose and maximal insulin secretory capacity in adolescents with type 2 diabetes.

    abstract:BACKGROUND:Adults with type 2 diabetes mellitus (T2DM) have broad impairments in beta-cell function, including severe attenuation of the first-phase insulin response to glucose, and reduced beta-cell mass. In adolescents with T2DM, there is some evidence that beta-cell dysfunction may be less severe. Our objective was ...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/j.1399-5448.2009.00601.x

    authors: Elder DA,Woo JG,D'Alessio DA

    更新日期:2010-08-01 00:00:00

  • A 5-yr follow-up nerve conduction study for the detection of subclinical diabetic neuropathy in children with newly diagnosed insulin-dependent diabetes mellitus.

    abstract:OBJECTIVE:To investigate the changes of peripheral nerve conduction in children with insulin-dependent diabetes mellitus (IDDM) prospectively from diagnosis and to know how those results were related to clinical risk factors. METHODS:A total of 37 patients (14 males and 23 females) aged 3-19 yr (mean 12.0 ± 3.7) with ...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/j.1399-5448.2009.00636.x

    authors: Lee SS,Han HS,Kim H

    更新日期:2010-12-01 00:00:00

  • First test effect in intravenous glucose tolerance testing.

    abstract:AIMS:Intravenous glucose tolerance testing (IVGTT) is a common test of β-cell function in which a glucose load is administered and insulin and/or C-peptide responses are monitored. Since the first IVGTT may be more stressful and stress may alter β-cell secretion or hepatic insulin extraction, we asked whether there was...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/pedi.12064

    authors: Ismail HM,White KS,Krischer JP,Chase HP,Cuthbertson D,Palmer JP,DPT-1 Study Group.

    更新日期:2015-03-01 00:00:00

  • Glycemic extremes in youth with T1DM: the structural and functional integrity of the developing brain.

    abstract::The adult brain accounts for a disproportionally large percentage of the body’s total energy consumption (1). However, during brain development,energy demand is even higher, reaching the adult rate by age 2 and increasing to nearly twice the adult rate by age 10, followed by gradual reduction toward adult levels in th...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章,评审

    doi:10.1111/pedi.12088

    authors: Arbelaez AM,Semenkovich K,Hershey T

    更新日期:2013-12-01 00:00:00

  • Predictive hyperglycemia and hypoglycemia minimization: In-home double-blind randomized controlled evaluation in children and young adolescents.

    abstract:OBJECTIVE:The primary objective of this trial was to evaluate the feasibility, safety, and efficacy of a predictive hyperglycemia and hypoglycemia minimization (PHHM) system vs predictive low glucose suspension (PLGS) alone in optimizing overnight glucose control in children 6 to 14 years old. RESEARCH DESIGN AND METH...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章,随机对照试验

    doi:10.1111/pedi.12603

    authors: Forlenza GP,Raghinaru D,Cameron F,Wayne Bequette B,Peter Chase H,Paul Wadwa R,Maahs DM,Jost E,Ly TT,Wilson DM,Norlander L,Ekhlaspour L,Min H,Clinton P,Njeru N,Lum JW,Kollman C,Beck RW,Buckingham BA,In-Home Closed-Lo

    更新日期:2018-05-01 00:00:00

  • Gender differences in the relationship between parental report of self-regulation skills and adolescents' management of type 1 diabetes.

    abstract:OBJECTIVE:To examine the extent to which self-regulation skills of adolescents with type 1 diabetes (T1D), including executive functioning and emotion regulation, relate to treatment adherence and glycemic control. METHOD:Participants were 109 adolescents aged 12-18 yr with TID and their primary caregiver who attended...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/j.1399-5448.2010.00692.x

    authors: Graziano PA,Geffken GR,Williams LB,Lewin AB,Duke DC,Storch EA,Silverstein JH

    更新日期:2011-06-01 00:00:00

  • Pathogenicity of a glucokinase gene mutation and description of its clinical phenotype.

    abstract::Glucokinase gene (GCK) mutations comprise approximately 10% of cases of maturity-onset diabetes of the young (MODY). Over 800 different mutations in GCK have been reported in the Human Gene Mutation Database, the vast majority of which result in MODY type 2. The missense mutation p.Leu122Val is listed in that database...

    journal_title:Pediatric diabetes

    pub_type:

    doi:10.1111/pedi.13058

    authors: Hunter JD,Staton H,Constantacos C,Walsh ET,Crudo DF

    更新日期:2020-09-01 00:00:00

  • Metformin treatment to reduce central adiposity after prenatal growth restraint: a placebo-controlled pilot study in prepubertal children.

    abstract:BACKGROUND:Children born small-for-gestational-age (SGA) who experience rapid postnatal catch-up in weight are at risk for central adiposity and hyperinsulinemia. OBJECTIVES:To study the effects of prepubertal metformin intervention over 24 months on the body composition and endocrine-metabolic profile of catch-up SGA...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1111/pedi.12220

    authors: Díaz M,Bassols J,López-Bermejo A,de Zegher F,Ibáñez L

    更新日期:2015-11-01 00:00:00

  • Differences in sleep architecture according to body mass index in children with type 1 diabetes.

    abstract::Slow wave sleep (SWS), or deep sleep, is thought to be the most restorative stage of sleep and may be of a particular interest in the pathophysiology of obesity. The aim of this study was to investigate differences in sleep architecture based on body mass index (BMI) among a pediatric population with type 1 diabetes m...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章,评审

    doi:10.1111/pedi.12918

    authors: Elrokhsi SH,Bluez GP,Chin CN,Wheeler MD,Silva GE,Perfect MM

    更新日期:2020-02-01 00:00:00

  • Worldwide childhood type 1 diabetes incidence--what can we learn from epidemiology?

    abstract::Type 1 diabetes is the most common form of diabetes in most part of the world, although reliable data are still unavailable in several countries. Wide variations exist between the incidence rates of different populations, incidence is lowest in China and Venezuela (0.1 per 100,000 per year) and highest in Finland and ...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/j.1399-5448.2007.00280.x

    authors: Soltesz G,Patterson CC,Dahlquist G,EURODIAB Study Group.

    更新日期:2007-10-01 00:00:00

  • Sweet dreams?--nocturnal hypoglycemia in children with type 1 diabetes.

    abstract::Hypoglycemia is an inevitable consequence of the treatment of type 1 diabetes in childhood. Nocturnal hypoglycemia is often considered as merely the submerged part of this serious complication yet there are reasons to believe that hypoglycemia occurring during sleep may be different in physiological terms. Glucose hom...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1034/j.1399-5448.2002.30203.x

    authors: Matyka KA

    更新日期:2002-06-01 00:00:00

  • Peripheral artery tonometry demonstrates altered endothelial function in children with type 1 diabetes.

    abstract:OBJECTIVES:To assess the ability of reactive hyperemia-peripheral artery tonometry (RH-PAT) to serve as a surrogate marker of endothelial dysfunction in children with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS:Forty-four children with T1D [age 14.6 +/- 2.7 yr; duration of diabetes 6.01 +/- 4 yr; range of diabe...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/j.1399-5448.2007.00246.x

    authors: Haller MJ,Stein J,Shuster J,Theriaque D,Silverstein J,Schatz DA,Earing MG,Lerman A,Mahmud FH

    更新日期:2007-08-01 00:00:00

  • Changes to Care Delivery at Nine International Pediatric Diabetes Clinics in Response to the COVID-19 Global Pandemic.

    abstract:BACKGROUND:Pediatric diabetes clinics around the world rapidly adapted care in response to COVID-19. We explored provider perceptions of care delivery adaptations and challenges for providers and patients across nine international pediatric diabetes clinics. METHODS:Providers in a quality improvement collaborative com...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/pedi.13180

    authors: Cristello Sarteau A,Souris KJ,Wang J,Ramadan AA,Addala A,Bowlby D,Corathers S,Forsander G,King B,Law JR,Liu W,Malik F,Pihoker C,Seid M,Smart C,Sundberg F,Tandon N,Yao M,Headley T,Mayer-Davis E

    更新日期:2021-01-19 00:00:00

  • Alterations in left ventricular, left atrial, and right ventricular structure and function to cardiovascular risk factors in adolescents with type 2 diabetes participating in the TODAY clinical trial.

    abstract::Data on cardiovascular disease (CVD) risk in adolescents with type 2 diabetes (T2D) are limited. Echocardiography was performed in the last year of the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) clinical trial (median 4½ yr from diagnosis of T2D, average age 18 yr), including MMode and 2D m...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1111/pedi.12119

    authors: Levitt Katz L,Gidding SS,Bacha F,Hirst K,McKay S,Pyle L,Lima JA,TODAY Study Group.

    更新日期:2015-02-01 00:00:00

  • Can the metabolic syndrome identify children with insulin resistance?

    abstract:OBJECTIVE:The metabolic syndrome is associated with insulin resistance in adults. We defined pediatric metabolic syndrome using criteria analogous to Adult Treatment Panel III. The purpose of this study was to determine whether these criteria are reliable for insulin resistance in children. RESEARCH DESIGN AND METHODS...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/j.1399-5448.2007.00282.x

    authors: Hirschler V,Calcagno ML,Aranda C,Maccallini G,Jadzinsky M

    更新日期:2007-10-01 00:00:00

  • A novel 3' untranslated region mutation in the SLC29A3 gene associated with pigmentary hypertrichosis and non-autoimmune insulin-dependent diabetes mellitus syndrome.

    abstract:BACKGROUND:Pigmentary hypertrichosis and non-autoimmune insulin-dependent diabetes mellitus (PHID) is one of the rare H syndrome diseases mainly characterized by hyperpigmentation, hypertrichosis, sensorineural hearing loss, cardiac complications, developmental delay, and diabetes mellitus (DM). Mutations in the coding...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/pedi.12839

    authors: Riachi M,Bas F,Darendeliler F,Hussain K

    更新日期:2019-06-01 00:00:00

  • The influence of physical activity on ghrelin and IGF-1/IGFBP-3 levels in children and adolescents with type 1 diabetes mellitus.

    abstract:OBJECTIVES:The aim of the study was to determine the influence of regular physical activity on ghrelin and IGF-1/IGFBP-3 levels during a diabetes camp. METHODS:Twenty-eight children and adolescents (14 boys; mean age 12.1 yr) with type 1 diabetes mellitus (T1DM, mean duration of diabetes 4.8 yr) attending a 2-wk diabe...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/j.1399-5448.2009.00604.x

    authors: Huber J,Fröhlich-Reiterer EE,Sudi K,Suppan E,Weinhandl G,Jasser-Nitsche H,Aigner R,Borkenstein MH

    更新日期:2010-09-01 00:00:00

  • Practical matters, rather than lack of trust, motivate non-participation in a long-term cohort trial.

    abstract:OBJECTIVE:The objective of this study was to investigate the importance of trust in researchers and other reasons that participating parents, former participants, and non-participants had for participating, or not participating, in a longitudinal cohort study on prediction and development of diabetes in children. STUD...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章

    doi:10.1111/j.1399-5448.2008.00498.x

    authors: Helgesson G,Hansson MG,Ludvigsson J,Swartling U

    更新日期:2009-09-01 00:00:00

  • Effects of insulin pump vs. injection treatment on quality of life and impact of disease in children with type 1 diabetes mellitus in a randomized, prospective comparison.

    abstract:OBJECTIVE:Effects of pump treatment vs. four times daily injections were explored in children with diabetes with regard to quality of life and impact of disease as well as adverse effects and parameters of metabolic control. METHODS:An open, parallel, randomized controlled prospective comparative study lasting 14 mont...

    journal_title:Pediatric diabetes

    pub_type: 杂志文章,随机对照试验

    doi:10.1111/j.1399-5448.2008.00396.x

    authors: Nuboer R,Borsboom GJ,Zoethout JA,Koot HM,Bruining J

    更新日期:2008-07-28 00:00:00

  • Corrigendum.

    abstract::In connection with the article entitled "A randomized trial comparing the rate of hypoglycemia – assessed using continuous glucose monitoring – in 125 preschool children with type 1 diabetes treated with insulin glargine or NPH insulin (the PRESCHOOL study)" which appeared in [1], we wish to bring the following correc...

    journal_title:Pediatric diabetes

    pub_type: 已发布勘误

    doi:10.1111/pedi.12207

    authors:

    更新日期:2015-09-01 00:00:00