PMID- 17448130
OWN - NLM
STAT- MEDLINE
DCOM- 20070705
LR  - 20240312
IS  - 1399-543X (Print)
IS  - 1399-5448 (Electronic)
IS  - 1399-543X (Linking)
VI  - 8
IP  - 2
DP  - 2007 Apr
TI  - Treatment options for type 2 diabetes in adolescents and youth: a study of the 
      comparative efficacy of metformin alone or in combination with rosiglitazone or 
      lifestyle intervention in adolescents with type 2 diabetes.
PG  - 74-87
AB  - Despite the increased prevalence of type 2 diabetes mellitus (T2DM) in the 
      pediatric population, there is limited information about the relative 
      effectiveness of treatment approaches. This article describes the rationale and 
      design of a National Institutes of Health-sponsored multi-site, randomized, 
      parallel group clinical trial designed to test the hypothesis that aggressive 
      reduction in insulin resistance early in the course of T2DM is beneficial for 
      prolongation of glycemic control, as well as improvement in associated 
      abnormalities and risk factors. Specifically, the trial compares treatment with 
      metformin with two alternate approaches, one pharmacologic (combining metformin 
      treatment with rosiglitazone) and one combining metformin with an intensive 
      lifestyle intervention program. The Treatment Options for Type 2 Diabetes in 
      Adolescents and Youth (TODAY) study recruits 800 patients over a 4-yr period and 
      follows them for a minimum of 2 yr and maximum of 6 yr. Patients are 10-17 yr of 
      age, within 2 yr of diagnosis of diabetes at the time of randomization, lack 
      evidence of autoimmunity, and have sustained C-peptide secretion. The primary 
      outcome is time to loss of glycemic control, defined as a hemoglobin A1c >8% for 
      6 consecutive months. Secondary outcomes include the effect of the alternative 
      treatments on insulin secretion and resistance, body composition, nutrition, 
      physical activity and fitness, cardiovascular risk monitoring, microvascular 
      complications, quality of life, depression, eating pathology, and resource 
      utilization. TODAY is the first large-scale, systematic study of treatment 
      effectiveness for T2DM in youth. When successfully completed, this study will 
      provide critical new information regarding the natural history of T2DM in youth, 
      the benefits of initiating early aggressive treatment in these patients, and the 
      efficacy of delivering an intensive and sustained lifestyle intervention to 
      children with T2DM.
CN  - TODAY Study Group
FAU - Zeitler, P
AU  - Zeitler P
FAU - Epstein, L
AU  - Epstein L
FAU - Grey, M
AU  - Grey M
FAU - Hirst, K
AU  - Hirst K
FAU - Kaufman, F
AU  - Kaufman F
FAU - Tamborlane, W
AU  - Tamborlane W
FAU - Wilfley, D
AU  - Wilfley D
LA  - eng
GR  - U01 DK061254/DK/NIDDK NIH HHS/United States
GR  - UL1 TR000005/TR/NCATS NIH HHS/United States
GR  - U01-DK61239/DK/NIDDK NIH HHS/United States
GR  - M01-RR00125/RR/NCRR NIH HHS/United States
GR  - U01-DK61242/DK/NIDDK NIH HHS/United States
GR  - M01 RR000069/RR/NCRR NIH HHS/United States
GR  - U01-DK61254/DK/NIDDK NIH HHS/United States
GR  - M01 RR000036/RR/NCRR NIH HHS/United States
GR  - U01-DK61212/DK/NIDDK NIH HHS/United States
GR  - U01 DK061242/DK/NIDDK NIH HHS/United States
GR  - U01-DK61230/DK/NIDDK NIH HHS/United States
GR  - U01 DK061212/DK/NIDDK NIH HHS/United States
GR  - M01-RR01066/RR/NCRR NIH HHS/United States
GR  - M01 RR001066/RR/NCRR NIH HHS/United States
GR  - M01 RR014467/RR/NCRR NIH HHS/United States
GR  - U01 DK061230/DK/NIDDK NIH HHS/United States
GR  - M01-RR00036/RR/NCRR NIH HHS/United States
GR  - M01 RR000043/RR/NCRR NIH HHS/United States
GR  - U01 DK061230-01/DK/NIDDK NIH HHS/United States
GR  - M01 RR000084/RR/NCRR NIH HHS/United States
GR  - M01-RR00043-45/RR/NCRR NIH HHS/United States
GR  - M01-RR00069/RR/NCRR NIH HHS/United States
GR  - M01-RR14467/RR/NCRR NIH HHS/United States
GR  - M01 RR000125/RR/NCRR NIH HHS/United States
GR  - U01 DK061239/DK/NIDDK NIH HHS/United States
GR  - M01-RR00084/RR/NCRR NIH HHS/United States
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PL  - Denmark
TA  - Pediatr Diabetes
JT  - Pediatric diabetes
JID - 100939345
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Thiazolidinediones)
RN  - 05V02F2KDG (Rosiglitazone)
RN  - 9100L32L2N (Metformin)
SB  - IM
MH  - Adolescent
MH  - Child
MH  - Diabetes Mellitus, Type 2/drug therapy/*therapy
MH  - Drug Therapy, Combination
MH  - Female
MH  - *Health Behavior
MH  - Humans
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Life Style
MH  - Male
MH  - Metformin/*therapeutic use
MH  - Rosiglitazone
MH  - Thiazolidinediones/*therapeutic use
MH  - Treatment Outcome
PMC - PMC2752327
MID - NIHMS118939
EDAT- 2007/04/24 09:00
MHDA- 2007/07/06 09:00
PMCR- 2009/09/25
CRDT- 2007/04/24 09:00
PHST- 2007/04/24 09:00 [pubmed]
PHST- 2007/07/06 09:00 [medline]
PHST- 2007/04/24 09:00 [entrez]
PHST- 2009/09/25 00:00 [pmc-release]
AID - PDI237 [pii]
AID - 10.1111/j.1399-5448.2007.00237.x [doi]
PST - ppublish
SO  - Pediatr Diabetes. 2007 Apr;8(2):74-87. doi: 10.1111/j.1399-5448.2007.00237.x.