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Research Project: Pediatric Clinical Nutrition

Location: Children's Nutrition Research Center

Title: Weight change in the management of youth-onset type 2 diabetes: The TODAY clinical trial experience

Author
item MARCUS, MARSHA - University Of Pittsburgh
item WILFLEY, DENISE - Washington University School Of Medicine
item EL GHORMLI, LAURE - George Washington University
item ZEITLER, PHIL - University Of Colorado
item LINDER, BARBARA - National Institute Of Diabetes And Digestive And Kidney Diseases
item HIRST, KATHRYN - George Washington University
item LEVERS-LANDIS, CAROLYN - Rainbow Babies And Children’s Hospital
item VAN BUREN, DOROTHY - Washington University School Of Medicine
item WALDERS-ABRAMSON, NATALIE - University Of Colorado
item HAYMOND, MOREY - Children'S Nutrition Research Center (CNRC)
item BACHA, FIDA - Children'S Nutrition Research Center (CNRC)

Submitted to: Pediatric Obesity
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 4/11/2016
Publication Date: 5/10/2016
Citation: Marcus, M.D., Wilfley, D.E., El Ghormli, L., Zeitler, P., Linder, B., Hirst, K., Levers-Landis, C.E., Van Buren, D.J., Walders-Abramson, N, The Today Study Group. 2016. Weight change in the management of youth-onset type 2 diabetes: The TODAY clinical trial experience. Pediatric Obesity. doi:10.1111/ijpo.12148.

Interpretive Summary: The Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) clinical trial found that there was limited effect of lifestyle intervention on glycemic control in youth with type 2 diabetes. This study examined weight changes among TODAY participants (aged 11–17 years) who completed at least 6 months of treatment, evaluated predictors of lifestyle outcome, and examined whether weight changes were related to cardiometabolic outcomes across treatment arms. We found that improvement in percent overweight across treatment arms was associated with changes in multiple cardiometabolic risk factors, and decreases of greater than or equal to 7% in overweight were associated with significant benefits over 24 months. The findings support the importance of lifestyle changes to optimize weight management in youth with Type 2 diabetes.

Technical Abstract: The Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) clinical trial documented that metformin plus rosiglitazone, but not metformin plus lifestyle intervention, provided superior durability of glycemic control relative to metformin monotherapy. We examined weight changes among TODAY participants that completed at least 6 months of treatment, evaluated predictors of lifestyle outcome, and examined whether weight changes were related to cardiometabolic outcomes across treatment arms. The 595 youth with type 2 diabetes, (85.1% of randomized participants aged 11–17 years) completed assessments of weight-related and cardiometabolic measures at months 0, 6, 12 and 24. Repeated measures models were used to investigate associations over time. Lifestyle intervention did not enhance outcome relative to metformin alone and no predictors of response to lifestyle treatment were identified. However, changes in percent overweight across treatment arms were associated with changes in multiple cardiometabolic risk factors, and decreases of greater than or equal to 7% in overweight were associated with significant benefits over 24 months. Although adjunctive intensive lifestyle intervention did not improve weight-related outcomes, weight changes in the full TODAY sample were associated with small, but significant improvements in cardiometabolic status, highlighting the importance of optimizing weight management in youth with type 2 diabetes.