Evidence map›Paper›PMID 26537182›Full record

Trial reportDiabetes care2015

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

Phil Zeitler, Kathryn Hirst, Kenneth C Copeland, Laure El Ghormli, Lorraine Levitt Katz, Lynne L Levitsky, Barbara Linder, Paul McGuigan, Neil H White, Denise Wilfley and 1 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes care, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00081328. Cited by 40 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00081328 phase3completed

Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Clinical Trial

Ran2004Enrolled699Registered outcomes11Posted comparisons0ConditionsDiabetes Mellitus, Type IIArmsLifestyle Program, Metformin, Rosiglitazone
PMID 22540912PMID 27803118PMID 24450390PMID 29246363PMID 31167889PMID 29532078PMID 27352955PMID 22332798PMID 31685489PMID 23704674PMID 29398050PMID 29697830other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Guideline
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  8. Review
  9. Article
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  15. Article
  16. Article
  17. Treatment strategy for children and adolescents with type 2 diabetes-based on ISPAD Clinical Practice Consensus Guidelines 2022.Clinical pediatric endocrinology : case reports and clinical investigations : official journal of the Japanese Society for Pediatric Endocrinology · 2023
    Review
  18. Article
  19. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Phil ZeitlerSection of Endocrinology, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.
Kathryn HirstGeorge Washington University Biostatistics Center, Rockville, MD khirst@bsc.gwu.edu.
Kenneth C CopelandUniversity of Oklahoma College of Medicine, Oklahoma City, OK.
Laure El GhormliGeorge Washington University Biostatistics Center, Rockville, MD.
Lorraine Levitt KatzChildren's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
Lynne L LevitskyMassachusetts General Hospital, Harvard Medical School, Boston, MA.
Barbara LinderDivision of Diabetes, Endocrinology and Metabolic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD.
Paul McGuiganRainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland, OH.
Neil H WhiteWashington University School of Medicine, St. Louis, MO.
Denise WilfleyWashington University School of Medicine, St. Louis, MO.
TODAY Study Group

Funding

Statistics Center for Pediatric Type 2 Diabetes TherapyU01DK061230 · GEORGE WASHINGTON UNIVERSITY · 2001 to 2005
$69.5M
ZOPOLRESTAT IN NORMOTENSIVE, TYPE 1 DIA WITH INCIPIENT NEPHROPATHYM01RR000043 · UNIVERSITY OF SOUTHERN CALIFORNIA · 1985 to 2005
$43.4M
ZD6416 Analgesic--Painful Distal Symmetrical PolyneuropaM01RR001066 · MASSACHUSETTS GENERAL HOSPITAL · 1985 to 2005
$26.1M
ZIPRASIDONE IN TOURETTES SYNDROME, OBSESSIVE COMPULSIVE &PERVASIVE DEV. DISORDERM01RR000125 · YALE UNIVERSITY · 1985 to 2005
$20.7M
XANAX PET SCAN/IV LACTATE PANIC STUDYM01RR000036 · WASHINGTON UNIVERSITY · 1985 to 2005
$20.4M
ZORVIRAX ORAL SUSPENSION FOR SEVERE CHILDHOOD HERPES VIRUS INFECTIONSM01RR000069 · UNIVERSITY OF COLORADO DENVER · 1985 to 2005
$15.4M
Trt. of Primary Hyperaldosteronism w/ACE Inhibitors &Angiotension Rec. BlockersM01RR014467 · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · 2001 to 2005
$7.3M
WATER PRECAUTIONS AND TYMPANOSTOMY TUBESM01RR000084 · CHILDREN'S HOSP PITTSBURGH/UPMC HLTH SYS · 1985 to 2005
$5.2M
Management of Pediatric Type 2 Diabetes MellitusU01DK061239 · CHILDRENS HOSPITAL OF PHILADELPHIA · 2001 to 2005
$4.6M
Multi-Center Study of the Treatment of T2DM in YouthU01DK061212 · YALE UNIVERSITY · 2001 to 2005
$3.9M
Type 2 Diabetes in Youth: Beta Cell PreservationU01DK061254 · CHILDREN'S HOSP PITTSBURGH/UPMC HLTH SYS · 2001 to 2005
$3.6M
Treatment Alternatives in Pediatric Type 2 DiabetesU01DK061242 · UNIVERSITY OF COLORADO DENVER · 2001 to 2005
$3.5M
NCATS NIH HHS UL1 TR000448NCATS NIH HHS UL1 TR001082NCRR NIH HHS M01 RR000036NCRR NIH HHS M01 RR000043NCRR NIH HHS M01 RR000069NCRR NIH HHS M01 RR000084NCRR NIH HHS M01 RR000125NCRR NIH HHS M01 RR001066NCRR NIH HHS M01 RR014467NCRR NIH HHS UL1 RR024134NCRR NIH HHS UL1 RR024139NCRR NIH HHS UL1 RR024153NCRR NIH HHS UL1 RR024989NCRR NIH HHS UL1 RR024992NCRR NIH HHS UL1 RR025758NCRR NIH HHS UL1 RR025780NIDDK NIH HHS P30 DK092950NIDDK NIH HHS U01 DK061212NIDDK NIH HHS U01 DK061230NIDDK NIH HHS U01 DK061239NIDDK NIH HHS U01 DK061242NIDDK NIH HHS U01 DK061254
6 · The paper itself

Abstract

objectiveTo 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

methodsTODAY 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. Outcome group was analyzed in univariate and multivariate models as a function of baseline characteristics (age, sex, race/ethnicity, socioeconomic status, BMI, waist circumference, Tanner stage, disease duration, depressive symptoms) and biochemical measures (HbA1c, C-peptide, lean and fat body mass, insulin inverse, insulinogenic index). Receiver operating characteristic curves were used to analyze HbA1c cut points.

resultsIn multivariate models including factors significant in univariate analysis, only HbA1c and insulinogenic index at randomization remained significant (P < 0.0001 and P = 0.0002, respectively). An HbA1c cutoff of 6.3% (45 mmol/mol) (positive likelihood ratio [PLR] 3.7) was identified that optimally distinguished the groups; sex-specific cutoffs were 6.3% (45 mmol/mol) for females (PLR 4.4) and 5.6% (38 mmol/mol) for males (PLR 2.1).

conclusionsIdentifying youth with type 2 diabetes at risk for rapid loss of glycemic control would allow more targeted therapy. HbA1c is a clinically accessible measure to identify high risk for loss of glycemic control on oral therapy. Adolescents with type 2 diabetes unable to attain a non-diabetes range HbA1c on metformin are at increased risk for rapid loss of glycemic control.

Indexed as

AdolescentBlood GlucoseDiabetes Mellitus, Type 2FemaleGlycated HemoglobinHumansHypoglycemic AgentsMaleMetforminBlood GlucoseGlycated HemoglobinHypoglycemic AgentsMetformin

Identifiers

PMID26537182
PMCPMC4657618

What Socratic holds

Texttitle and abstract
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.