Actos Now for the prevention of diabetes (ACT NOW) study
BACKGROUND: Impaired 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...
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Formato: | Texto |
Lenguaje: | English |
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BioMed Central
2009
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2725044/ https://www.ncbi.nlm.nih.gov/pubmed/19640291 http://dx.doi.org/10.1186/1472-6823-9-17 |
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author | DeFronzo, Ralph A Banerji, MaryAnn Bray, George A Buchanan, Thomas A Clement, Stephen Henry, Robert R Kitabchi, Abbas E Mudaliar, Sunder Musi, Nicolas Ratner, Robert Reaven, Peter D Schwenke, Dawn Stentz, Frankie B Tripathy, Devjit |
author_facet | DeFronzo, Ralph A Banerji, MaryAnn Bray, George A Buchanan, Thomas A Clement, Stephen Henry, Robert R Kitabchi, Abbas E Mudaliar, Sunder Musi, Nicolas Ratner, Robert Reaven, Peter D Schwenke, Dawn Stentz, Frankie B Tripathy, Devjit |
author_sort | DeFronzo, Ralph A |
collection | PubMed |
description | BACKGROUND: Impaired 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/DESIGN: 602 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, HbA(1C), 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 ≥ 126 or 2-hour PG ≥ 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. CONCLUSION: ACT 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 REGISTRATION: clinical trials.gov identifier: NCT00220961 |
format | Text |
id | pubmed-2725044 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2009 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-27250442009-08-12 Actos Now for the prevention of diabetes (ACT NOW) study DeFronzo, Ralph A Banerji, MaryAnn Bray, George A Buchanan, Thomas A Clement, Stephen Henry, Robert R Kitabchi, Abbas E Mudaliar, Sunder Musi, Nicolas Ratner, Robert Reaven, Peter D Schwenke, Dawn Stentz, Frankie B Tripathy, Devjit BMC Endocr Disord Study Protocol BACKGROUND: Impaired 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/DESIGN: 602 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, HbA(1C), 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 ≥ 126 or 2-hour PG ≥ 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. CONCLUSION: ACT 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 REGISTRATION: clinical trials.gov identifier: NCT00220961 BioMed Central 2009-07-29 /pmc/articles/PMC2725044/ /pubmed/19640291 http://dx.doi.org/10.1186/1472-6823-9-17 Text en Copyright © 2009 DeFronzo et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( (http://creativecommons.org/licenses/by/2.0) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Study Protocol DeFronzo, Ralph A Banerji, MaryAnn Bray, George A Buchanan, Thomas A Clement, Stephen Henry, Robert R Kitabchi, Abbas E Mudaliar, Sunder Musi, Nicolas Ratner, Robert Reaven, Peter D Schwenke, Dawn Stentz, Frankie B Tripathy, Devjit Actos Now for the prevention of diabetes (ACT NOW) study |
title | Actos Now for the prevention of diabetes (ACT NOW) study |
title_full | Actos Now for the prevention of diabetes (ACT NOW) study |
title_fullStr | Actos Now for the prevention of diabetes (ACT NOW) study |
title_full_unstemmed | Actos Now for the prevention of diabetes (ACT NOW) study |
title_short | Actos Now for the prevention of diabetes (ACT NOW) study |
title_sort | actos now for the prevention of diabetes (act now) study |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2725044/ https://www.ncbi.nlm.nih.gov/pubmed/19640291 http://dx.doi.org/10.1186/1472-6823-9-17 |
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