Trial reportAnnals of internal medicine2019

Long-Term Weight Loss With Metformin or Lifestyle Intervention in the Diabetes Prevention Program Outcomes Study.

John W Apolzan, Elizabeth M Venditti, Sharon L Edelstein, William C Knowler, Dana Dabelea, Edward J Boyko, Xavier Pi-Sunyer, Rita R Kalyani, Paul W Franks, Preethi Srikanthan and 2 more

Erratum issued 3 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled TrialVideo-Audio Media
In one paragraph

Trial report in Annals of internal medicine, 2019. The graph read 3 numbers from its abstract, feeding 2 cells of the map, but none could be read as for or against, so it casts no vote. An erratum has been issued. It reports registered trial NCT00004992. Cited by 75 papers, 3 of them syntheses that pooled it.

3numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed, 3 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.

Read, but not usablea number the graph found but could not read as for or against

Mean weight loss relative to baseline that was maintained between years 6 and 15metformin vs baseline weight, in participants who lost at least 5% of baseline weight in the first yeardescribes a change within one group, not a comparison · t2d, obesityfeeds one cell of the map
weight loss -6.20-7.20 to -5.20
After the masked treatment phase ended, the mean weight loss relative to baseline that was maintained between years 6 and 15 was 6.2% (95% CI, 5.2% to 7.2%) in the metformin group, 3.7% (CI, 3.1% to 4.4%) in the ILS group, and 2.8% (CI, 1.3% to 4.4%) in the placebo group.
Mean weight loss relative to baseline that was maintained between years 6 and 15intensive lifestyle intervention (ILS) vs baseline weight, in participants who lost at least 5% of baseline weight in the first yeardescribes a change within one group, not a comparison · t2d, obesityfeeds one cell of the map
Δ -3.70-4.40 to -3.10
After the masked treatment phase ended, the mean weight loss relative to baseline that was maintained between years 6 and 15 was 6.2% (95% CI, 5.2% to 7.2%) in the metformin group, 3.7% (CI, 3.1% to 4.4%) in the ILS group, and 2.8% (CI, 1.3% to 4.4%) in the placebo group.
Mean weight loss relative to baseline that was maintained between years 6 and 15placebo vs baseline weight, in participants who lost at least 5% of baseline weight in the first yeardescribes a change within one group, not a comparison · t2d, obesityfeeds one cell of the map
Δ -2.80-4.40 to -1.30
After the masked treatment phase ended, the mean weight loss relative to baseline that was maintained between years 6 and 15 was 6.2% (95% CI, 5.2% to 7.2%) in the metformin group, 3.7% (CI, 3.1% to 4.4%) in the ILS group, and 2.8% (CI, 1.3% to 4.4%) in the placebo group.

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

Diet, exercise & lifestyle×body weight & composition

No readable resultOpen on the map →What to test next →

3 readable studies in this cell: 2 favour the treatment, 0 find no difference, 1 favour the comparator.

Belief with this paper
0.12contested · 1 family supports, 2 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the treatmentfavours the comparator →
0 · no effect
Δ -5.40-9.00 to -1.70
estimated mean change 7.034.25 to 9.80

This paper's own estimate is on a different scale from the rest of the cell, so it is not drawn here.

Metformin×body weight & composition

No readable resultOpen on the map →What to test next →

19 readable studies in this cell: 7 favour the treatment, 6 find no difference, 6 favour the comparator.

Belief with this paper
0.50contested · 8 families support, 4 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the comparatorfavours the treatment →
0 · no effect
NCT018093271,186 enrolled · 2013
Δ -0.90-1.60 to -0.20
NCT008598981,093 enrolled · 2009
Δ -1.37-2.03 to -0.71
NCT00643851994 enrolled · 2008
Δ -0.05-0.72 to 0.61
NCT02932475831 enrolled · 2017
Δ 0.04
NCT00676338820 enrolled · 2008
Δ -0.04-0.61 to 0.53
NCT02980276535 enrolled · 2017
Δ -0.70-1.30 to -0.20
Δ 17.05.00 to 29.0
increase 1.26-0.24 to 2.75
weight loss -16.2-60.2 to -4.40

This paper's own estimate is on a different scale from the rest of the cell, so it is not drawn here.

4 · 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
NCT07163455 naactive not recruitingnot on this mapstarted 2026, after this paper: background citation

Time-Restricted Eating (10-Hour Window) for Weight-Loss Maintenance in Adults With Recent Intentional Weight Loss: A Multicenter, 12-Month Randomized Controlled Trial

TypeinterventionalSponsorHarbin Medical UniversityRan2026 to 2028Enrolled500ConditionsOverweight or Obese AdultsArmsScheduled Weight Maintenance Nutrition Education, Time-Restricted Eating (10-Hour Window)
5 · Its place in the literature

Who cites it

75 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Guideline
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  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
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  10. Trial
  11. Trial
  12. Review
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  14. Review
  15. Article
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  19. Review
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15 more citing papers are in PubMed but not listed here.

6 · The record

Corrections and comments

7 · Who and what money

Authors and funding

12 authors.

John W ApolzanPennington Biomedical Research Center, Louisiana State University System, Baton Rouge, Louisiana (J.W.A., K.M.G.).
Elizabeth M VendittiWestern Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (E.M.V.).
Sharon L EdelsteinGeorge Washington University Biostatistics Center, Rockville, Maryland (S.L.E.).
William C KnowlerNational Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, Arizona (W.C.K.).
Dana DabeleaColorado School of Public Health, Aurora, Colorado (D.D.).
Edward J BoykoSeattle Epidemiologic Research and Information Center, VA Puget Sound Health Care System, Seattle, Washington (E.J.B.).
Xavier Pi-SunyerColumbia University College of Physicians and Surgeons, New York, New York (X.P.).
Rita R KalyaniJohns Hopkins University School of Medicine, Baltimore, Maryland (R.R.K.).
Paul W FranksLund University Diabetes Centre, Skåne University Hospital, Malmö, Sweden (P.W.F.).
Preethi SrikanthanUniversity of California, Los Angeles, Los Angeles, California (P.S.).
Kishore M GaddePennington Biomedical Research Center, Louisiana State University System, Baton Rouge, Louisiana (J.W.A., K.M.G.).
Diabetes Prevention Program Research Group

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
USE OF OXANDROLONE TO IMPROVE FUNCTION IN CHRONIC SCIM01RR016587 · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · 2002 to 2005
$6.8M
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
Louisiana Clinical and Translational Science CenterU54GM104940 · LSU PENNINGTON BIOMEDICAL RESEARCH CTR · 2025 to 2025
$3.9M
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
NCRR NIH HHS M01 RR016587NIDDK NIH HHS P30 DK017047NIDDK NIH HHS R01 DK078907NIDDK NIH HHS U01 DK048339NIDDK NIH HHS U01 DK048349NIDDK NIH HHS U01 DK048375NIDDK NIH HHS U01 DK048377NIDDK NIH HHS U01 DK048381NIDDK NIH HHS U01 DK048397NIDDK NIH HHS U01 DK048400NIDDK NIH HHS U01 DK048404NIDDK NIH HHS U01 DK048406NIDDK 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 DK048514NIGMS NIH HHS U54 GM104940
8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

Background: Identifying reliable predictors of long-term weight loss (LTWL) could lead to improved weight management. Objective: To identify some predictors of LTWL. Design: The DPP (Diabetes Prevention Program) was a randomized controlled trial that compared weight loss with metformin, intensive lifestyle intervention (ILS), or placebo. Its Outcomes Study (DPPOS) observed patients after the masked treatment phase ended. (ClinicalTrials.gov: NCT00004992 and NCT00038727). Setting: 27 DPP and DPPOS clinics. Participants: Of the 3234 randomly assigned participants, 1066 lost at least 5% of baseline weight in the first year and were followed for 15 years. Measurements: Treatment assignment, personal characteristics, and weight. Results: After 1 year, 289 (28.5%) participants in the metformin group, 640 (62.6%) in the ILS group, and 137 (13.4%) in the placebo group had lost at least 5% of their weight. After the masked treatment phase ended, the mean weight loss relative to baseline that was maintained between years 6 and 15 was 6.2% (95% CI, 5.2% to 7.2%) in the metformin group, 3.7% (CI, 3.1% to 4.4%) in the ILS group, and 2.8% (CI, 1.3% to 4.4%) in the placebo group. Independent predictors of LTWL included greater weight loss in the first year in all groups, older age and continued metformin use in the metformin group, older age and absence of either diabetes or a family history of diabetes in the ILS group, and higher fasting plasma glucose levels at baseline in the placebo group. Limitation: Post hoc analysis; examination of nonrandomized subsets of randomized groups after year 1. Conclusion: Among persons with weight loss of at least 5% after 1 year, those originally randomly assigned to metformin had the greatest loss during years 6 to 15. Older age and the amount of weight initially lost were the most consistent predictors of LTWL maintenance. Primary Funding Source: National Institutes of Health.

Indexed as

Life StyleDiabetes Mellitus, Type 2FemaleHumansHypoglycemic AgentsMaleMetforminMiddle AgedUnited StatesWeight LossHypoglycemic AgentsMetformin

Identifiers

PMID31009939
PMCPMC6829283

What Socratic 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 Socratic graph.