Evidence map›Paper›PMID 33428709›Full record

Trial reportThe journals of gerontology. Series A, Biological sciences and medical sciences2021

Association of Intensive Lifestyle and Metformin Interventions With Frailty in the Diabetes Prevention Program Outcomes Study.

Helen P Hazuda, Qing Pan, Hermes Florez, José A Luchsinger, Jill P Crandall, Elizabeth M Venditti, Sherita H Golden, Andrea M Kriska, George A Bray

2 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The journals of gerontology. Series A, Biological sciences and medical sciences, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00004992. Cited by 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 pooled it
3.0field-weighted citation impact, top 8% 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.

NCT00004992 phase3completed

Diabetes Prevention Program

Ran1996Enrolled3,234Registered outcomes1Posted comparisons0ConditionsDiabetes Mellitus, Non-Insulin-Dependent, Glucose IntoleranceArmsIntensive lifestyle, Metformin, Placebo
PMID 11832527PMID 16855264other papers from this trial
Open the trial in the graph
NCT00038727 phase3completed

Diabetes Prevention Program Outcomes Study

Ran1996Enrolled2,779Registered outcomes17Posted comparisons2ConditionsCancer, CVD, Diabetes MellitusArmsDPPOS Boost Lifestyle, DPPOS Group Lifestyle, Intensive Lifestyle Group Session, Metformin
PMID 19878986PMID 26377054PMID 11832527other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Article
  8. Review
  9. Review
  10. Article
  11. Review
  12. Article
  13. Article
  14. Frailty and Cardiovascular Health.Journal of the American Heart Association · 2024
    Review
  15. Article
  16. Review
  17. Article
  18. Review
  19. Article
  20. Physiological Systems in Promoting Frailty.Comprehensive Physiology · 2022
    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

9 authors at 8 institutions in 1 country.

Helen P HazudaUniversity of Texas Health Science Center at San Antonio.
Qing PanBiostatistics Center, The George Washington University.
Hermes FlorezUniversity of Miami, Florida.
José A LuchsingerColumbia University Irving Medical Center, New York, New York.
Jill P CrandallAlbert Einstein College of Medicine, Bronx, New York.
Elizabeth M VendittiUniversity of Pittsburgh, Pennsylvania.
Sherita H GoldenJohns Hopkins University, Baltimore, Maryland.
Andrea M KriskaUniversity of Pittsburgh, Pennsylvania.
George A BrayPennington Biomedical Research Center, Baton Rouge, Louisiana.
University of Pittsburgh · USAlbert Einstein College of Medicine · USColumbia University Irving Medical Center · USGeorge Washington University · USJohns Hopkins University · USPennington Biomedical Research Center · USThe University of Texas Health Science Center at San Antonio · USUniversity of Miami · US

Funding

PRIMARY PREVENTION TRIAL--DATA COORDINATING CENTERU01DK048489 · GEORGE WASHINGTON UNIVERSITY · 1994 to 2005
$23.7M
Vector and Transgenic Mouse CoreP30DK017047 · NIDDK · UNIVERSITY OF WASHINGTON · 1986 to 2025
$12.6M
Post-DDP Follow-up StudyU01DK048413 · UNIVERSITY OF WASHINGTON · 1994 to 2005
$4.4M
TITLE OMITTEDU01DK048349 · YESHIVA UNIVERSITY · 1994 to 2005
$4.0M
PRIMARY PREVENTION TRIALU01DK048443 · UNIVERSITY OF SOUTHERN CALIFORNIA · 1994 to 2005
$4.0M
PRIMARY PREVENTION TRIAL (DPT-2)U01DK048397 · MASSACHUSETTS GENERAL HOSPITAL · 1994 to 2005
$3.8M
Post-DPP Follow-up StudyU01DK048485 · JOHNS HOPKINS UNIVERSITY · 1994 to 2005
$3.7M
NIDDM PRIMARY PREVENTION TRIALU01DK048412 · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 1994 to 2005
$3.6M
PRIMARY PREVENTION TRIAL (DPT-2)U01DK048339 · UNIVERSITY OF CALIFORNIA SAN DIEGO · 1994 to 2005
$3.6M
Post-DPP Follow-Up StudyU01DK048400 · WASHINGTON UNIVERSITY · 1994 to 2005
$3.6M
Post-DPP Follow-up StudyU01DK048437 · JOSLIN DIABETES CENTER · 1994 to 2005
$3.5M
NIDDM PRIMARY PREVENTION TRIAL (DPT 2)U01DK048404 · ST. LUKE'S-ROOSEVELT INST FOR HLTH SCIS · 1994 to 2005
$3.5M
NIDDK NIH HHS P30 DK017047NIDDK NIH HHS P30 DK111022NIDDK NIH HHS P30 DK123704NIDDK NIH HHS R01 DK078907NIDDK NIH HHS U01 DK048339NIDDK NIH HHS U01 DK048349NIDDK NIH HHS U01 DK048375NIDDK NIH HHS U01 DK048380NIDDK NIH HHS U01 DK048381NIDDK NIH HHS U01 DK048387NIDDK NIH HHS U01 DK048397NIDDK NIH HHS U01 DK048400NIDDK NIH HHS U01 DK048404NIDDK NIH HHS U01 DK048407NIDDK NIH HHS U01 DK048412NIDDK NIH HHS U01 DK048413NIDDK NIH HHS U01 DK048434NIDDK NIH HHS U01 DK048437NIDDK NIH HHS U01 DK048443NIDDK NIH HHS U01 DK048468NIDDK NIH HHS U01 DK048485NIDDK NIH HHS U01 DK048489NIDDK NIH HHS U01 DK048514
6 · The paper itself

Abstract

backgroundFrailty is a geriatric syndrome of decreased physiologic reserve and resistance to stressors that results in increased vulnerability to adverse health outcomes with aging. Diabetes and hyperglycemia are established risk factors for frailty. We sought to examine whether the odds of frailty among individuals at high risk of diabetes randomized to treatment with intensive lifestyle (ILS), metformin, or placebo differed after long-term follow-up.

methodThe sample comprised participants in the Diabetes Prevention Program (DPP) clinical trial, who continued follow-up in the DPP Outcomes Study (DPPOS) and completed frailty assessments in DPPOS Years 8 (n = 2385) and 10 (n = 2289), approximately 12 and 14 years after DPP randomization. Frailty was classified using Fried Frailty Phenotype criteria. GEE models adjusting for visit year with repeated measures pooled for Years 8 and 10 were used to estimate pairwise odds ratios (ORs) between ILS, metformin, and placebo for the outcomes of frail and prefrail versus nonfrail.

resultsFrailty prevalence by treatment group was ILS = 3.0%, metformin = 5.4%, placebo = 5.7% at Year 8, and ILS = 3.6%, metformin = 5.3%, placebo = 5.4% at Year 10. Odds ratios (95% CI) estimated with GEE models were ILS versus placebo, 0.62 (0.42-0.93), p = .022; metformin versus placebo, 0.99 (0.69-1.42), p = .976; and ILS versus metformin, 0.63 (0.42-0.94), p = .022. Odds of being frail versus nonfrail were 37% lower for ILS compared to metformin and placebo.

conclusionsEarly ILS intervention, at an average age of about 50 years, in persons at high risk of diabetes may reduce frailty prevalence in later life. Metformin may be ineffective in reducing frailty prevalence. CLINICAL TRIALS REGISTRATION NUMBERS: NCT00004992 (DPP) and NCT00038727 (DPPOS).

Indexed as

Life StyleDiabetes Mellitus, Type 2FemaleFollow-Up StudiesFrailtyHumansHypoglycemic AgentsMaleMetforminMiddle AgedHypoglycemic AgentsMetforminBehavioral modificationGeriatric syndromesPharmacotherapyPrediabetes

Identifiers

PMID33428709
PMCPMC8087265
OpenAlexW3119963873

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.