Dataset Information

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

ABSTRACT: 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.To describe the experience of youth participating in a 2-6 month run-in period in preparation for randomization into TODAY.An ethnically diverse sample of 927 youth, 65.4% females, aged 13.7 ± 2.0 yr old, with type 2 diabetes for a median of 2 months (0.7-7.8 months, 25th-75th percentiles).A run-in period was conducted to achieve HbA1c <8% with metformin monotherapy and diabetes education, and to evaluate adherence to pill taking, visit attendance, and other procedures.At entry, mean body mass index (BMI) and z-BMI were 35.6 ± 7.7 and 2.3 ± 0.4, respectively, mean HbA1c was 7.7 ± 2.2%, only 42.5% were on a hypoglycemic treatment, and 35.6% had HbA1c ?8%. Comorbid conditions were common; 18.8% had hypertension, 24.2% had elevated cholesterol, and 6.5% had abnormal liver enzymes. After a median 71 d of run-in, 90.9% had HbA1c <8%, 77.9% had HbA1c <7%, and 46.4% had HbA1c <6%. Of the 772 youth achieving the target HbA1c <8%, 704 (91.2%) were randomized; non-adherence to metformin treatment was the main cause for non-randomization. Youth proceeding to randomization decreased weight by 0.68?kg and HbA1c by 1.45% compared to a weight gain of 0.71?kg and HbA1c decrease of 0.74% in the non-randomized youth (p = 0.01 in both cases). However, change in z-BMI was not significantly different between the two groups.Most youth with recent onset type 2 diabetes can achieve target HbA1c <8.0% with short-term metformin monotherapy and standard diabetes education (ClinicalTrials.gov identifier: NCT00081328).

SUBMITTER: Laffel L

PROVIDER: S-EPMC3371323 | biostudies-literature | 2012 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Laffel Lori L Chang Nancy N Grey Margaret M Hale Dan D Higgins Laurie L Hirst Kathryn K Izquierdo Roberto R Larkin Mary M Macha Christina C Pham Trang T Wauters Aimee A Weinstock Ruth S RS

Pediatric diabetes 20120227 5

<h4>Background</h4>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.<h4>Objective</h4>To describe the experience of youth participating in a 2-6 month run-in period in preparation for randomization into TODAY.<h4>Subjects</h4>An ethnically diverse sample of 927 youth, 65.4% females, aged 13.7 ± 2.0 yr old, with type 2 diabetes for a median of 2 months (0.7-7 ...[more]

PMID: 22369102

Similar Datasets

Project description: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.After an average 7.3?years of follow-up (range 4.9-9.5), Treatment Options for type 2 Diabetes in Adolescents and Youth participants completed a survey examining their perceptions of the benefits and barriers to sustained involvement in the protocol.The most common reasons for staying in Treatment Options for type 2 Diabetes in Adolescents and Youth included having a strong relationship with the medical team, getting study-provided diabetes care, access to free diabetes medicine and supplies, and being part of a large study to learn more about how to care for youth-onset type 2 diabetes. The most commonly endorsed challenges included scheduling conflicts, possibly disappointing others, difficulties getting to study visits, and the occurrence of other medical issues.Similar to other published reports, a supportive relationship with study staff was commonly endorsed as a benefit of engagement in the longitudinal study, suggesting that rapport, staff consistency, and relationship quality are important components of optimal retention. Moreover, our findings suggest the value of trying to remove logistical barriers, such as transportation and scheduling challenges, in order to promote long-term participation in research. Further research is recommended to evaluate factors that contribute to attrition versus retention in an a priori manner within longitudinal studies, especially protocols involving cohorts that are more vulnerable to attrition due to developmental transitions and/or socioeconomic challenges. Additional efforts to optimize quantitative and qualitative measurement of barriers would also help to expand our understanding of how to optimally retain participants in longitudinal protocols.

Dataset Information

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

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure