Evidence map›Paper›PMID 19640291›Full record

ArticleBMC endocrine disorders2009

Actos Now for the prevention of diabetes (ACT NOW) study.

Ralph A Defronzo, Maryann Banerji, George A Bray, Thomas A Buchanan, Stephen Clement, Robert R Henry, Abbas E Kitabchi, Sunder Mudaliar, Nicolas Musi, Robert Ratner and 4 more

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in BMC endocrine disorders, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
9.1field-weighted citation impact, top 2% 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.

NCT04131582 phase3unknown statusstarted 2019, after this paper: background citation

Effect of a Quadruple Therapy on Pancreatic Islet Function, Insulin Resistance and Cardiovascular Function in Patients With Mixed Prediabetes and Obesity: Randomized Clinical Trial

Ran2019Enrolled34Registered outcomes4Posted comparisons0ConditionsInsulin Resistance, Prediabetic StateArmsLinagliptin + metformin and Empagliflozin + metformin, Metformin
Open the trial in the graph
NCT00220961 phase3completednot on this map

Actos Now for Prevention of Diabetes (ACT NOW)

TypeinterventionalSponsorThe University of Texas Health Science Center at San AntonioRan2004 to 2010Enrolled602ConditionsImpaired Glucose Tolerance, Type 2 DiabetesArmsPioglitazone, Placebo
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 1 synthesis or guideline pooled it, 89 citations in OpenAlex.

  1. Pooled it
  2. Trial
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  14. Making Strides in Type 2 Diabetes Prevention.Diabetes spectrum : a publication of the American Diabetes Association · 2018
    Article
  15. Article
  16. Article
  17. Article
  18. Efficacy and Safety of Canagliflozin as Add-On Therapy to Metformin in Type 2 Diabetes.Clinical diabetes : a publication of the American Diabetes Association · 2014
    Article
  19. Review
  20. Article
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

14 authors at 10 institutions in 1 country.

Ralph A DefronzoTexas Diabetes Institute and University of Texas Health Science Center, San Antonio, TX, USA. albarado@uthscsa.edu
Maryann Banerji
George A Bray
Thomas A Buchanan
Stephen Clement
Robert R Henry
Abbas E Kitabchi
Sunder Mudaliar
Nicolas Musi
Robert Ratner
Peter D Reaven
Dawn Schwenke
Frankie B Stentz
Devjit Tripathy
The University of Texas Health Science Center at San Antonio · USUniversity of Tennessee Health Science Center · USVA San Diego Healthcare System · USArizona State University · USGeorgetown University · USMedStar Health · USPennington Biomedical Research Center · USPhoenix VA Health Care System · USSUNY Downstate Health Sciences University · USUniversity of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImpaired glucose tolerance (IGT) is a prediabetic state. If IGT can be prevented from progressing to overt diabetes, hyperglycemia-related complications can be avoided. The purpose of the present study was to examine whether pioglitazone (ACTOS) can prevent progression of IGT to type 2 diabetes mellitus (T2DM) in a prospective randomized, double blind, placebo controlled trial. METHODS/

design602 IGT subjects were identified with OGTT (2-hour plasma glucose = 140-199 mg/dl). In addition, IGT subjects were required to have FPG = 95-125 mg/dl and at least one other high risk characteristic. Prior to randomization all subjects had measurement of ankle-arm blood pressure, systolic/diastolic blood pressure, HbA1C, lipid profile and a subset had frequently sampled intravenous glucose tolerance test (FSIVGTT), DEXA, and ultrasound determination of carotid intima-media thickness (IMT). Following this, subjects were randomized to receive pioglitazone (45 mg/day) or placebo, and returned every 2-3 months for FPG determination and annually for OGTT. Repeat carotid IMT measurement was performed at 18 months and study end. Recruitment took place over 24 months, and subjects were followed for an additional 24 months. At study end (48 months) or at time of diagnosis of diabetes the OGTT, FSIVGTT, DEXA, carotid IMT, and all other measurements were repeated.Primary endpoint is conversion of IGT to T2DM based upon FPG >or= 126 or 2-hour PG >or= 200 mg/dl. Secondary endpoints include whether pioglitazone can: (i) improve glycemic control (ii) enhance insulin sensitivity, (iii) augment beta cell function, (iv) improve risk factors for cardiovascular disease, (v) cause regression/slow progression of carotid IMT, (vi) revert newly diagnosed diabetes to normal glucose tolerance.

conclusionACT NOW is designed to determine if pioglitazone can prevent/delay progression to diabetes in high risk IGT subjects, and to define the mechanisms (improved insulin sensitivity and/or enhanced beta cell function) via which pioglitazone exerts its beneficial effect on glucose metabolism to prevent/delay onset of T2DM.

trial registrationclinical trials.gov identifier: NCT00220961.

Identifiers

PMID19640291
PMCPMC2725044
OpenAlexW2015852718

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.