Evidence map›Paper›PMID 32064729›Full record

Trial reportPediatric diabetes2020

Beta cell function and insulin sensitivity in obese youth with maturity onset diabetes of youth mutations vs type 2 diabetes in TODAY: Longitudinal observations and glycemic failure.

Silva Arslanian, Laure El Ghormli, Morey H Haymond, Christine L Chan, Steven D Chernausek, Rachelle G Gandica, Rose Gubitosi-Klug, Lynne L Levitsky, Maggie Siska, Steven M Willi and 1 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Pediatric diabetes, 2020. 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 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 28% of its field
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
Open the trial in the graph
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
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 at 10 institutions in 1 country.

Silva ArslanianUPMC Children's Hospital of Pittsburgh, University of Pittsburgh, Pittsburgh, Pennsylvania.ORCID 0000-0002-1528-9324
Laure El GhormliGeorge Washington University Biostatistics Center, Rockville, Maryland.ORCID 0000-0003-4223-8407
Morey H HaymondBaylor College of Medicine, Houston, Texas.
Christine L ChanUniversity of Colorado Anschutz Medical Campus, Aurora, Colorado.
Steven D ChernausekUniversity of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.
Rachelle G GandicaColumbia University, New York, New York.
Rose Gubitosi-KlugCase Western Reserve University, Cleveland, Ohio.ORCID 0000-0002-7376-6870
Lynne L LevitskyMassachusetts General Hospital, Boston, Massachusetts.ORCID 0000-0002-3898-3933
Maggie SiskaSaint Louis University, St. Louis, Missouri.
Steven M WilliChildren's Hospital of Philadelphia, Philadelphia, Pennsylvania.
TODAY Study Group
Baylor College of Medicine · USCase Western Reserve University · USChildren's Hospital of Philadelphia · USColumbia University · USGeorge Washington University · USMassachusetts General Hospital · USSaint Louis University · USUniversity of Colorado Anschutz Medical Campus · USUniversity of Oklahoma Health Sciences Center · USUniversity of Pittsburgh · US

Funding

Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) StudyU01DK061230 · NIDDK · GEORGE WASHINGTON UNIVERSITY · PI BRAFFETT, BARBARA HALINA, ZEITLER, PHILIP S. · 2001 to 2019
$231.8M
WU INSTITUTE OF CLINICAL AND TRANSLATIONAL SCIENCESUL1TR002345 · NCATS · WASHINGTON UNIVERSITY · PI William G. Powderly · 2017 to 2026
$97.8M
HARVARD CLINICAL AND TRANSLATIONAL SCIENCE CENTER (UL1)UL1RR025758 · NCRR · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2008 to 2011
$91.4M
ZOPOLRESTAT IN NORMOTENSIVE, TYPE 1 DIA WITH INCIPIENT NEPHROPATHYM01RR000043 · NCRR · UNIVERSITY OF SOUTHERN CALIFORNIA · PI PULIAFITO, CARMEN A · 1985 to 2010
$76.4M
UNIVERSITY OF PITTSBURGH CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE: BPCAUL1RR024153 · NCRR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2006 to 2011
$73.9M
INSTITUTIONAL CLINICAL AND TRANSLATIONAL SCIENCE AWARDUL1RR024134 · NCRR · UNIVERSITY OF PENNSYLVANIA · PI FITZGERALD, GARRET A · 2006 to 2011
$70.4M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025780 · NCRR · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2008 to 2011
$61.3M
YALE UNIVERSITY CLINICAL AND TRANSLATIONAL SCIENCE AWARD PROGRAMUL1RR024139 · NCRR · YALE UNIVERSITY · PI SHERWIN, ROBERT S · 2006 to 2011
$56.8M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024989 · NCRR · CASE WESTERN RESERVE UNIVERSITY · PI DAVIS, PAMELA B · 2007 to 2011
$53.7M
Washington University Institute of Clinical and Translational Sciences (UL1)UL1RR024992 · NCRR · WASHINGTON UNIVERSITY · PI EVANOFF, BRADLEY A · 2007 to 2011
$45.4M
ZD6416 Analgesic--Painful Distal Symmetrical PolyneuropaM01RR001066 · NCRR · MASSACHUSETTS GENERAL HOSPITAL · PI GRINSPOON, STEVEN K. · 1985 to 2008
$37.4M
Clinical and Translational Science Collaborative of ClevelandUL1TR002548 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI MCCOMSEY, GRACE A · 2018 to 2022
$35.5M
NCATS NIH HHS UL1 TR002345NCATS NIH HHS UL1 TR002548NCRR 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 U01 DK061212NIDDK NIH HHS U01 DK061230NIDDK NIH HHS U01 DK061239NIDDK NIH HHS U01 DK061242NIDDK NIH HHS U01 DK061254NIDDK NIH HHS U01-DK61212NIDDK NIH HHS U01-DK61230NIDDK NIH HHS U01-DK61239NIDDK NIH HHS U01-DK61242
6 · The paper itself

Abstract

objectiveIn treatment options for type 2 diabetes in adolescents and youth (TODAY), 4.5% of obese youth clinically diagnosed with type 2 diabetes (T2D) had genetic variants consistent with maturity onset diabetes of youth (MODY) diagnosis. The course of IS and β-cell function in obese youth with MODY remains unknown. In this secondary analysis, we examined IS and β-cell function in MODY vs. non-MODY obese youth at randomization and over time.

methodsGenetic data in TODAY included 426 non-MODY (T2D) and 22 MODY youth (7 glucokinase MODY mutation positive [GCK-MODY], 12 hepatocyte nuclear factor MODY mutation positive [HNF-MODY], 2 Insulin gene mutation [insulin (INS)-MODY], and 1 Kruppel-like factor 11 [KLF11-MODY]). Oral glucose tolerance test (OGTT)-derived IS, C-peptide index, and β-cell function relative to IS oral disposition index (oDI) was measured at randomization, and over 24 months in addition to total and high-molecular-weight adiponectin (HMWA).

resultsAt randomization, IS, total adiponectin, and HMWA were significantly higher in the two MODY groups than in non-MODY. β-cell function measured by C-peptide oDI was 3-fold higher in GCK-MODY than in HNF-MODY and 1.5-fold higher than non-MODY (P for both <.05). Glycemic failure rate was 75.0% in HNF-MODY, 46.9% in non-MODY, and zero in GCK-MODY youth. While the changes in IS and oDI were not different among the three groups in the first 6 months, IS improved from 6 to 24 months in HNF-MODY vs GCK-MODY youth.

conclusionsIn TODAY, β-cell function at randomization was worse in obese HNF-MODY youth compared with GCK-MODY youth, while insulin sensitivity was worse in non-MODY compared with the other two MODY groups. Over time, IS showed the greatest improvement in HNF-MODY youth. This raises the possibility that TODAY therapeutic modalities of insulin sensitization in these obese HNF-MODY youth may have played a beneficial role.

Indexed as

Diabetes Mellitus, Type 2Pediatric ObesityAdolescentChildCombined Modality TherapyDrug Therapy, CombinationFemaleGlucokinaseHepatocyte Nuclear Factor 4HumansInsulin ResistanceInsulin-Secreting CellsLife StyleLongitudinal StudiesMaleMetforminGlucokinaseHepatocyte Nuclear Factor 4HNF4A protein, humanMetforminRosiglitazoneglycemic controlinsulin secretioninsulin sensitivityMODYtype 2 diabetesyouth

Identifiers

PMID32064729
PMCPMC7654712
OpenAlexW3007324625

What OpenQuestion holds

Texttitle and abstract
LicenceTDM
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 OpenQuestion graph.