Evidence map›Paper›PMID 34274407›Full record

Trial reportDiabetes research and clinical practice2021

Differential loss of β-cell function in youth vs. adults following treatment withdrawal in the Restoring Insulin Secretion (RISE) study.

Kristina M Utzschneider, Mark T Tripputi, Alexandra Kozedub, Elena Barengolts, Sonia Caprio, Melanie Cree-Green, Sharon L Edelstein, Laure El Ghormli, Tamara S Hannon, Kieren J Mather and 3 more

2 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes research and clinical practice, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01779362. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
5.2field-weighted citation impact, top 4% 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.

NCT01779362 phase3completed

Restoring Insulin Secretion Adult Medication Study

Ran2013Enrolled267Registered outcomes4Posted comparisons4ConditionsPrediabetes, Type 2 DiabetesArmsGlargine, liraglutide, Metformin, Placebo
PMID 24194506PMID 28493515other papers from this trial
Open the trial in the graph
NCT01779375 phase3completed

Restoring Insulin Secretion Pediatric Medication Study

Ran2013Enrolled91Registered outcomes6Posted comparisons3ConditionsPrediabetes, Type 2 DiabetesArmsGlargine, Metformin
Open the trial in the graph
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.

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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

13 authors at 7 institutions in 1 country.

Kristina M UtzschneiderVA Puget Sound Health Care System, Seattle, WA, United States; Department of Medicine, University of Washington, Seattle, WA, United States.
Mark T TripputiGeorge Washington University Biostatistics Center, Rockville, MD, United States.
Alexandra KozedubVA Puget Sound Health Care System, Seattle, WA, United States.
Elena BarengoltsJesse Brown VA Medical Center, Chicago, IL, United States.
Sonia CaprioDepartment of Pediatrics, Yale University, New Haven, CT, United States.
Melanie Cree-GreenUniversity of Colorado Anschutz Medical Campus/Children's Hospital Colorado, Denver, CO, United States.
Sharon L EdelsteinGeorge Washington University Biostatistics Center, Rockville, MD, United States.
Laure El GhormliGeorge Washington University Biostatistics Center, Rockville, MD, United States.
Tamara S HannonIndiana University School of Medicine, Indianapolis, IN, United States.
Kieren J MatherIndiana University School of Medicine, Indianapolis, IN, United States.
Jerry PalmerVA Puget Sound Health Care System, Seattle, WA, United States; Department of Medicine, University of Washington, Seattle, WA, United States.
Kristen J NadeauUniversity of Colorado Anschutz Medical Campus/Children's Hospital Colorado, Denver, CO, United States.
RISE Consortium
George Washington University · USVA Puget Sound Health Care System · USIndiana University – Purdue University Indianapolis · USChildren's Hospital Colorado · USJesse Brown VA Medical Center · USUniversity of Colorado Denver · USYale University · US

Funding

University of Pittsburgh Clinical and Translational Science InstituteUL1TR001857 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2016 to 2025
$129.3M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Southern California Clinical and Translational Science InstituteUL1TR001855 · NCATS · UNIVERSITY OF SOUTHERN CALIFORNIA · PI Thomas A Buchanan, Michele D. Kipke · 2016 to 2026
$81.3M
Colorado Clinical and Translational Sciences InstituteUL1TR001082 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2013 to 2017
$48.0M
Yale Diabetes Research CenterP30DK045735 · NIDDK · YALE UNIVERSITY · PI Richard A Flavell · 1993 to 2026
$44.0M
Vector and Transgenic Mouse CoreP30DK017047 · NIDDK · UNIVERSITY OF WASHINGTON · PI Tomas Vaisar · 1986 to 2026
$41.4M
PILOT STUDY--SUBSTRATE METABOLISM IN EXTREMELY LOW BIRTH WEIGHT INFANTSP30DK048520 · NIDDK · UNIVERSITY OF COLORADO DENVER · PI Wendy M Kohrt · 1995 to 2026
$32.6M
Indiana Clinical and Translational Sciences InstituteUL1TR001108 · NCATS · INDIANA UNIVERSITY INDIANAPOLIS · PI DENNE, SCOTT C., SHEKHAR, ANANTHA · 2013 to 2017
$23.3M
Pilot and Feasibility ProgramP30DK020595 · NIDDK · UNIVERSITY OF CHICAGO · PI Matthew J Brady · 2013 to 2026
$20.9M
Re-Engineering Translational Research at the University of ChicagoUL1TR000430 · NCATS · UNIVERSITY OF CHICAGO · PI SOLWAY, JULIAN · 2012 to 2016
$20.2M
Translation CoreP30DK097512 · NIDDK · INDIANA UNIVERSITY INDIANAPOLIS · PI Carmella Evans-Molina · 2015 to 2026
$17.4M
NRSA Training CoreTL1TR001858 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI RADOMSKI, THOMAS, RUBIO, DORIS M · 2016 to 2025
$11.1M
NCATS NIH HHS TL1 TR001858NCATS NIH HHS UL1 TR000430NCATS NIH HHS UL1 TR001082NCATS NIH HHS UL1 TR001108NCATS NIH HHS UL1 TR001855NCATS NIH HHS UL1 TR001857NCATS NIH HHS UL1 TR001863NHLBI NIH HHS K24 HL145076NIDDK NIH HHS P30 DK017047NIDDK NIH HHS P30 DK020595NIDDK NIH HHS P30 DK045735NIDDK NIH HHS P30 DK048520NIDDK NIH HHS P30 DK097512NIDDK NIH HHS U01 DK094406NIDDK NIH HHS U01 DK094430NIDDK NIH HHS U01 DK094431NIDDK NIH HHS U01 DK094438NIDDK NIH HHS U01 DK094467
6 · The paper itself

Abstract

aimsTo compare OGTT-derived estimates of β-cell function between youth and adults with impaired glucose tolerance (IGT) or recently diagnosed type 2 diabetes after treatment discontinuation in RISE.

methodsYouth (n = 89) and adults (n = 132) were randomized to 3 months glargine followed by 9 months metformin (G/M) or 12 months metformin (MET). Insulin sensitivity and β-cell responses were estimated from 3-hour OGTTs over 21 months. Linear mixed models tested for differences by time and age group within each treatment arm.

resultsAfter treatment withdrawal, HbA1c increased in both youth and adults with a larger net increase in G/M youth vs. adults at 21 months. Among youth, β-cell function decreased starting at 12 months in G/M and 15 months in MET. Among adults, β-cell function remained relatively stable although insulin secretion rates decreased in G/M at 21 months. At 21 months vs. baseline β-cell function declined to a greater extent in youth vs. adults in both the G/M and MET treatment arms.

conclusionsAfter treatment withdrawal youth demonstrated progressive decline in β-cell function after stopping treatment with either G/M or MET. In contrast, β-cell function in adults remained stable despite an increase in HbA1c over time. ClinicalTrials.gov Identifier: NCT01779375 and NCT01779362 at clinical trials.gov.

Indexed as

Diabetes Mellitus, Type 2Glucose IntoleranceInsulin ResistanceAdolescentAdultBlood GlucoseGlucose Tolerance TestHumansInsulinInsulin SecretionBlood GlucoseInsulinImpaired glucose toleranceInsulin secretionMetforminType 2 diabetesYouthβ-cell function

Identifiers

PMID34274407
PMCPMC8628318
OpenAlexW3186962169

What OpenQuestion holds

Textmetadata
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.