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Results from the TODAY Clinical Trial 784 Diabetes Care Volume 38, May 2015 Parental Characteristics Ruth S. Weinstock,1 Paula M. Trief,1 Laure El ghormli,2 Robin Goland,3 Associated With Outcomes in Siripoom McKay,4 Kerry Milaszewski,5 Jeff Preske,6 Steven Willi,7 and Youth With Type 2 Diabetes: Patrice M. Yasuda8 Results From the TODAY Clinical Trial Diabetes Care 2015;38:784–792 | DOI: 10.2337/dc14-2393 CLIN CARE/EDUCATION/NUTRITION/PSYCHOSOCIAL OBJECTIVE This study examined parental factors associated with outcomes of youth in the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) clinical trial. RESEARCH DESIGN AND METHODS Of 699 youth with type 2 diabetes in the TODAY cohort, 623 (89.1%) had a parent participate and provide data at baseline, including weight, HbA1c, blood pressure, 1 symptoms of depression, binge eating (BE), and medical history. Youth were State University of New York Upstate Medical – University, Syracuse, NY followed 2 6.5 years. Data were analyzed using regression models and survival 2George Washington University Biostatistics curve methods. Center, Rockville, MD 3Columbia University, New York, NY RESULTS 4Baylor College of Medicine, Houston, TX 5Joslin Diabetes Center, Boston, MA Parental diabetes (43.6% of parents) was associated with higher baseline HbA1c 6 P < University of Oklahoma Health Sciences Center, ( 0.0001) and failure of youths to maintain glycemic control on study treatment Oklahoma City, OK (53.6% vs. 38.2% failure rate among those without a diabetic parent, P = 0.0002). 7Children’s Hospital of Philadelphia and Perel- Parental hypertension (40.6% of parents) was associated with hypertension in man School of Medicine at the University of youth during TODAY (40.4% vs. 27.4% of youth with and without parental hyper- Pennsylvania, Philadelphia, PA 8Children’s Hospital Los Angeles and Keck School tension had hypertension, P = 0.0008) and with higher youth baseline BMI z scores of Medicine at the University of Southern Califor- (P = 0.0038). Parents had a mean baseline BMI of 33.6 kg/m2.Parentalobesity nia, Los Angeles, CA 2 (BMI >30 kg/m ) was associated with higher baseline BMI z scores in the youth (P < Corresponding author: Laure El ghormli, 0.0001). Depressive symptoms in parents (20.6% of parents) were related to youth [email protected]. depressive symptoms at baseline only (P = 0.0430); subclinical BE in parents was Received 9 October 2014 and accepted 2 Febru- related to the presence of subclinical BE (P = 0.0354) and depressive symptoms ary 2015. (P = 0.0326) in youth throughout the study period. Clinical trial reg. no. NCT00081328, clinicaltrials .gov. CONCLUSIONS A complete list of the TODAY Study Group can be Parental diabetes and hypertension were associated with lack of glycemic control, found in the APPENDIX. hypertension, and higher BMI z scores in youth. Further research is needed to © 2015 by the American Diabetes Association. Readers may use this article as long as the work better understand and address parental biological and behavioral factors to im- is properly cited, the use is educational and not prove youth health outcomes. for profit, and the work is not altered. care.diabetesjournals.org Weinstock and Associates 785 Youth-onset type 2 diabetes has been (reflecting major medical problems (Y-EDEQ) were used to identify the pres- on the rise for two decades in the U.S. in parents according to standard clin- ence of BE, defined as the number of Diabetes-related complications and ical trial SAE criteria) associated with times in the past 28 days the participant comorbidities, including retinopathy, failure to maintain glycemic control reported episodes of overeating with an hypertension, and albuminuria, are in their youth, youth medication ad- associated loss of control. Subclinical BE now observed in adolescents (1–8). herence, BMI z score, and diabetes- was defined as reporting 1–3BEepi- Treatment Options for type 2 Diabetes related complications? sodes in the past month, and clinical in Adolescents and Youth (TODAY) was BE was $4 (17). The BDI, CDI, and Y- one of the first large randomized clini- RESEARCH DESIGN AND METHODS EDEQ were administered to the youth cal trials to evaluate the safety and ef- The design of the TODAY study has been at baseline, month 6, and month 24 of ficacy of different treatment regimens previously described (13,14). Over- the study. Youth hypertension, microal- (9). The multicenter study group en- weight youth (n = 699, ages 10–17) buminuria, depressive symptoms, sub- rolled and monitored the largest with recent-onset type 2 diabetes (me- clinical BE, and clinical BE were assessed ethnically diverse and well-characterized dian 5 months) were randomized to at baseline and cumulatively during the cohort of youth with type 2 diabetes in receive metformin alone, metformin entire study period (including baseline the world. with rosiglitazone, or metformin with through end of study visits). A family history of type 2 diabetes in- an intensive lifestyle intervention. The Each youth was accompanied by an creases the risk of children developing primary outcome was time to treatment adult caregiver, called the family support diabetes (10), but whether the presence failure based on glycemic control (HbA1c person (FSP), most of whom were parents. of diabetes in the parent is associated .8% [.64 mmol/mol]) over 6 months TheFSPhadtoprovidesignedinformed with more difficulty in achieving and or inability to wean from temporary consent stating willingness to perform maintaining glycemic control in youth insulin therapy within 3 months after functions, including accompanying the and/or the earlier development of acute metabolic decompensation. Data youth to all study visits and participating diabetes-related complications is un- collected on youth at baseline included in data collection. Baseline data were col- known. The physical and mental health age, sex, race/ethnicity, and family lected from FSPs, including age, sex, race/ status of a parent may affect the general structure (with whom the participant ethnicity, height, and weight measured by health or functioning of the child lived). Height, weight, HbA1c,andblood clinic staff, depressive symptoms (BDI), (11,12). However, whether the presence pressure were assessed in youth at andanadultversionoftheEDEQtode- of parental obesity, hypertension, and/ baseline, every 2 months in the first termine subclinical and clinical BE defined or depression is associated with greater year, and quarterly thereafter. Urine al- in a similar manner as for the youth (18). hypertension, obesity, and depressive bumin and creatinine were assessed at History of diabetes and hypertension were symptoms in their children with type 2 baseline and annually. Medication ad- obtained from the biological FSP parent diabetes has not been well studied. The herence based on pill count was as- via self-report at baseline. Highest house- TODAY study collected data from the sessed at each follow-up visit with a hold level of education and total house- parents of youth participants, allowing goal of $80%. SAEs (based on standard hold annual income were recorded. SAEs for analyses that could help increase our definitions for clinical trials) that oc- occurring in FSPs, such as death, hospital- understanding of how parental health curred in youth during the study were ization, birth of a baby with a congenital status may affect the health and behav- also collected. Hypertension was de- anomaly, disability, or any other life- ior of youth with type 2 diabetes. This fined as high blood pressure ($130/80 threatening medical event, were docu- information could inform the future de- mmHg or $95th percentile for age, sex, mented during follow-up. velopment of targeted parent/child in- and height based on Centers for Disease The protocol was approved by the in- terventions to improve outcomes for Control and Prevention normative data) stitutional review board for each of the youth with type 2 diabetes. The current or use of appropriate medication. Micro- participating institutions. All participants analyses examined the following ques- albuminuria was defined as an albumin- provided informed consent and minor tions in TODAY study participants: to-creatinine ratio $30 mg/mg in two of child assent. three urine samples collected over $3 1. Is the presence of diabetes in a par- months or use of appropriate medica- Statistical Methods ent associated with poorer glycemic tion. Retinopathy was assessed by fundus Associations between parental character- outcomes (failure to maintain glycemic photography in the last year of the istics and youth outcomes were analyzed control), youth medication adherence, study (7). using logistic regression models (for bi- BMI z score, and diabetes-related Depressive symptoms during the nary outcomes) and general linear models complications? past 2 weeks were assessed using the (for continuous outcomes). 2. Is the presence of parental hyperten- Children’s Depression Inventory (CDI) Comparison of glycemic failure on as- sion or obesity associated with hyper- for participants up to age 16 or the Beck signed treatment in the youth by parental tension or obesity in the offspring? Depression Inventory (BDI) for those 16 diabetes status and diagnosis of youth hy- 3. Is the presence of depressive symp- or older. A score $13 on the CDI or $14 pertension by parental hypertension were toms or binge eating (BE) in parents on the BDI indicated clinically significant analyzed using survival curve methodol- associated with youth outcomes? levels of depressive symptoms (15,16). ogy with log-rank tests. At baseline, all 4. Is the occurrence of medical serious Responses on the self-report Youth Eat- TODAY youth were free of glycemic failure adverse events (SAEs) in parents ing Disorder Examination Questionnaire per study protocol but could be enrolled if 786 Parental Factors in Youth-Onset Type 2 Diabetes Diabetes Care Volume 38, May 2015 previously diagnosed with hypertension were mothers (97.6% biological) and (5,7,9,19–22): 63.4% were female, at that was controlled with appropriate med- 11.4% were fathers (95.8% biological).
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