Healthcare and associated costs related to type 2 diabetes in youth and adolescence: the TODAY clinical trial experience.

The economic issues related to medical treatments in youth with type 2 diabetes (T2D) are rarely reported and thus not fully understood. The Treatment Options for type 2 Diabetes in Adolescents and Youth clinical trial of youth recently diagnosed with T2D collected healthcare and related cost information from the largest cohort studied to date. Costs related to medical treatments and expenses faced by caregivers were identified over a 2-year period from 496 participants.

Depressive symptoms and glycemic control in youth with type 2 diabetes participating in the TODAY clinical trial.

The relationship between depressive symptoms and glycemic control in youth with type 2 diabetes was assessed at baseline (n = 682), 6, and/or 24 months (n = 576). Neither baseline nor persistence of depressive symptoms was significantly associated with maintenance of glycemic control. Nevertheless, depressive symptoms were common, suggesting the importance of repeated screening.

Adherence to a lifestyle program for youth with type 2 diabetes and its association with treatment outcome in the TODAY clinical trial.

Objective: To assess the association of proxies of behavioral adherence to the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) lifestyle program with changes in glycemic control and obesity in a multi-ethnic sample of youth with type 2 diabetes.

Methods: The TODAY clinical trial included an intensive lifestyle intervention to promote weight reduction. Adherence was assessed with measures of attendance at intervention sessions and rates of self-monitoring of diet and physical activity by participants and their caregivers.

Correlates of Medication Adherence in the TODAY Cohort of Youth With Type 2 Diabetes.

Objective: To identify factors that predict medication adherence and to examine relationships among adherence, glycemic control, and indices of insulin action in TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth).

Research Design And Methods: A total of 699 youth 10-17 years old with recent-onset type 2 diabetes and ≥80% adherence to metformin therapy for ≥8 weeks during a run-in period were randomized to receive one of three treatments. Participants took two study pills twice daily.

Effects of comorbid conditions on health-related quality of life in youth with Type 2 diabetes: the TODAY clinical trial.

Aim: To explore associations between health-related quality of life (HRQOL) and comorbidities in youth with Type 2 diabetes.

Patients & Methods: Of 699 youth in the TODAY study, 685 (98%) had baseline HRQOL data, 649 (93%) at 6 months and 583 (83%) at 24 months. Comorbidities were defined by sustained abnormal values and treatment regimens.

HbA1c After a Short Period of Monotherapy With Metformin Identifies Durable Glycemic Control Among Adolescents With Type 2 Diabetes.

Objective: To determine whether clinically accessible parameters early in the course of youth-onset type 2 diabetes predict likelihood of durable control on oral therapy.

Research Design And Methods: TODAY was a randomized clinical trial of adolescents with type 2 diabetes. Two groups, including participants from all three treatments, were defined for analysis: (1) those who remained in glycemic control for at least 48 months of follow-up and (2) those who lost glycemic control before 48 months.

Benefits and barriers to participating in longitudinal research of youth-onset type 2 diabetes: Results from the TODAY retention survey.

Background/aims: Conducting longitudinal research related to chronic illness in adolescents is inherently challenging due to developmental changes and psychosocial stressors. Participants in the Treatment Options for type 2 Diabetes in Adolescents and Youth clinical trial were socioeconomically disadvantaged as well. This study assessed attitudes and beliefs about retention in Treatment Options for type 2 Diabetes in Adolescents and Youth to shed light on the factors that potentially promote and detract from the likelihood of sustained participation.

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.

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 measurements of left ventricular (LV) and left atrial (LA) dimensions, LV tissue Doppler imaging (TDI), and tricuspid annular plane systolic excursion (TAPSE). Relationships between cardiac structure and function with demographic characteristics and baseline and change-from-baseline in CVD risk factors were examined in 455 participants.

Impact of implementation and conduct of the HEALTHY primary prevention trial on student performance.

Purpose: To determine whether a school-wide intervention program to reduce risk factors for type 2 diabetes (T2D) affected student achievement, rates of disciplinary actions, and attendance rates.

Design: The HEALTHY primary prevention trial was designed to evaluate a comprehensive school-based intervention to reduce factors for T2D, especially overweight and obesity. Students were followed up from beginning of sixth grade (Fall 2006) through end of eighth grade (Spring 2009).

Interactive learning activities for the middle school classroom to promote healthy energy balance and decrease diabetes risk in the HEALTHY primary prevention trial.

The HEALTHY trial evaluated the effectiveness of a multicomponent intervention program to reduce risk for type 2 diabetes in middle school students. The comprehensive intervention addressed nutrition, physical activity, and behavior in the context of a social marketing-based communications campaign to promote healthy energy balance. One element was a classroom-based program called FLASH (Fun Learning Activities for Student Health).

Diabetes screening with hemoglobin A(1c) versus fasting plasma glucose in a multiethnic middle-school cohort.

Objective: To characterize middle-school students from the HEALTHY study with glycemic abnormalities, specifically high-risk hemoglobin A(1c) (A1C) (hrA1C; A1C = 5.7-6.4%) and impaired fasting glucose (IFG; fasting plasma glucose [FPG] = 100-125 mg/dL).

Lessons learned from the HEALTHY primary prevention trial of risk factors for type 2 diabetes in middle school youth.

The HEALTHY trial was designed to take a primary prevention approach to risk factors for type 2 diabetes in youth, primarily obesity. The study involved over 6,000 students at 42 middle schools across the U.S.

A clinical trial to maintain glycemic control in youth with type 2 diabetes.

Background: Despite the increasing prevalence of type 2 diabetes in youth, there are few data to guide treatment. We compared the efficacy of three treatment regimens to achieve durable glycemic control in children and adolescents with recent-onset type 2 diabetes.

Methods: Eligible patients 10 to 17 years of age were treated with metformin (at a dose of 1000 mg twice daily) to attain a glycated hemoglobin level of less than 8% and were randomly assigned to continued treatment with metformin alone or to metformin combined with rosiglitazone (4 mg twice a day) or a lifestyle-intervention program focusing on weight loss through eating and activity behaviors.

Metformin monotherapy in youth with recent onset type 2 diabetes: experience from the prerandomization run-in phase of the TODAY study.

Background: TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) is a federally funded multicenter randomized clinical trial comparing three treatments of youth onset type 2 diabetes.

Objective: To describe the experience of youth participating in a 2-6 month run-in period in preparation for randomization into TODAY.

Subjects: An ethnically diverse sample of 927 youth, 65.

Effects of 100 and 300 units of onabotulinum toxin A on lower urinary tract symptoms of benign prostatic hyperplasia: a phase II randomized clinical trial.

Purpose: We conducted a 2-stage, multicenter, double-blind, randomized phase II clinical trial of 100 and 300 unit doses of onabotulinum toxin A to treat the lower urinary tract symptoms of benign prostatic hyperplasia.

Materials And Methods: Men 50 years old or older with clinically diagnosed benign prostatic hyperplasia, American Urological Association symptom index 8 or greater, maximum urinary flow rate less than 15 ml per second, voided volume 125 ml or greater, and post-void residual 350 ml or less were randomized to prostatic transrectal injection of 100 or 300 units of onabotulinum toxin A. The primary outcome was at least 30% improvement from baseline to 3 months in American Urological Association symptom index and/or maximum urinary flow rate and safety.

Depression and pregnancy stressors affect the association between abuse and postpartum depression.

To determine how psychosocial factors affect the association between a history of abuse and postpartum depression (PPD). Women at four urban hospitals in Utah were enrolled ≤ 48 h of delivering a live-born infant. At enrollment, pregravid history of physical or sexual abuse was obtained via self-report.

Characteristics of adolescents and youth with recent-onset type 2 diabetes: the TODAY cohort at baseline.

Context: The Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) cohort represents the largest and best-characterized national sample of American youth with recent-onset type 2 diabetes.

Objective: The objective of the study was to describe the baseline characteristics of participants in the TODAY randomized clinical trial.

Design: Participants were recruited over 4 yr at 15 clinical centers in the United States (n = 704) and enrolled, randomized, treated, and followed up 2-6 yr.

Postpartum major depression.

Postpartum major depression is a disorder that is often unrecognized and must be distinguished from "baby blues." Antenatal depressive symptoms, a history of major depressive disorder, or previous postpartum major depression significantly increase the risk of postpartum major depression. Screening with the Edinburgh Postnatal Depression Scale may be appropriate.

A school-based intervention for diabetes risk reduction.

Background: We examined the effects of a multicomponent, school-based program addressing risk factors for diabetes among children whose race or ethnic group and socioeconomic status placed them at high risk for obesity and type 2 diabetes.

Methods: Using a cluster design, we randomly assigned 42 schools to either a multicomponent school-based intervention (21 schools) or assessment only (control, 21 schools). A total of 4603 students participated (mean [+/- SD] age, 11.

HEALTHY study rationale, design and methods: moderating risk of type 2 diabetes in multi-ethnic middle school students.

The HEALTHY primary prevention trial was designed and implemented in response to the growing numbers of children and adolescents being diagnosed with type 2 diabetes. The objective was to moderate risk factors for type 2 diabetes. Modifiable risk factors measured were indicators of adiposity and glycemic dysregulation: body mass index > or =85th percentile, fasting glucose > or =5.

Risk factors for type 2 diabetes in a sixth- grade multiracial cohort: the HEALTHY study.

Objective: HEALTHY is a 3-year middle school intervention program designed to reduce risk factors for type 2 diabetes. The prevalence of diabetes risk factors at baseline in a cohort of 6,358 sixth-grade students is reported.

Research Design And Methods: Forty-two schools at seven U.

Comparison of sarcoidosis phenotypes among affected African-American siblings.

Study Objective: To test the hypothesis that sibling pairs, who share genes and environmental exposures, might have similar phenotypic expressions of sarcoidosis beyond what would be expected by chance alone.

Design: Multicenter family study with study subjects recruited from 11 clinical centers.

Subjects: Subjects were African-American sibling pairs with sarcoidosis.

A sarcoidosis genetic linkage consortium: the sarcoidosis genetic analysis (SAGA) study.

Background: Sarcoidosis, a systemic granulomatous disease of unknown etiology, likely results from an environmental insult in a genetically susceptible host. In the United States of America, African Americans have a higher sarcoidosis incidence and suffer greater morbidity than Caucasians.

Methods: A sarcoidosis genetic linkage study consortium was established to recruit African-American affected sib pair (ASP) families to identify chromosomal regions that may harbor sarcoidosis susceptibility genes and to determine if environmental factors modify any genetic effects.