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

Pediatr Obes. 2017 Aug;12(4):337-345. doi: 10.1111/ijpo.12148. Epub 2016 May 10.


Background: 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.

Objectives: 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.

Methods: 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.

Results: 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 ≥ 7% in overweight were associated with significant benefits over 24 months.

Conclusions: 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 T2DM.

Trial registration: ClinicalTrials.gov NCT00081328.

Keywords: behavioral weight control; cardiometabolic risk; lifestyle; type 2 diabetes.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Anthropometry
  • Blood Glucose / drug effects
  • Body Weight*
  • Child
  • Diabetes Mellitus, Type 2 / physiopathology
  • Diabetes Mellitus, Type 2 / therapy*
  • Drug Combinations
  • Female
  • Humans
  • Hypoglycemic Agents / therapeutic use*
  • Life Style
  • Male
  • Metformin / therapeutic use*
  • Risk Factors
  • Thiazoles / therapeutic use*
  • Treatment Outcome


  • Blood Glucose
  • Drug Combinations
  • Hypoglycemic Agents
  • Thiazoles
  • rosiglitazone-metformin combination
  • Metformin

Associated data

  • ClinicalTrials.gov/NCT00081328