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

Ralph A Defronzo, Mary Ann 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

Research output: Contribution to journalArticle

53 Citations (Scopus)

Abstract

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, 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 ≥ 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.

Original languageEnglish (US)
Article number17
JournalBMC Endocrine Disorders
Volume9
DOIs
StatePublished - Jul 31 2009

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pioglitazone
Glucose Intolerance
Glucose Tolerance Test
Carotid Intima-Media Thickness
Type 2 Diabetes Mellitus
Blood Pressure
Glucose
Insulin Resistance
Placebos
Prediabetic State
Diabetes Complications
Random Allocation
Ankle
Hyperglycemia
Arm

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism

Cite this

Defronzo, R. A., Banerji, M. A., Bray, G. A., Buchanan, T. A., Clement, S., Henry, R. R., ... Tripathy, D. (2009). Actos Now for the prevention of diabetes (ACT NOW) study. BMC Endocrine Disorders, 9, [17]. https://doi.org/10.1186/1472-6823-9-17

Actos Now for the prevention of diabetes (ACT NOW) study. / Defronzo, Ralph A; Banerji, Mary Ann; 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.

In: BMC Endocrine Disorders, Vol. 9, 17, 31.07.2009.

Research output: Contribution to journalArticle

Defronzo, RA, Banerji, MA, Bray, GA, Buchanan, TA, Clement, S, Henry, RR, Kitabchi, AE, Mudaliar, S, Musi, N, Ratner, R, Reaven, PD, Schwenke, D, Stentz, FB & Tripathy, D 2009, 'Actos Now for the prevention of diabetes (ACT NOW) study', BMC Endocrine Disorders, vol. 9, 17. https://doi.org/10.1186/1472-6823-9-17
Defronzo RA, Banerji MA, Bray GA, Buchanan TA, Clement S, Henry RR et al. Actos Now for the prevention of diabetes (ACT NOW) study. BMC Endocrine Disorders. 2009 Jul 31;9. 17. https://doi.org/10.1186/1472-6823-9-17
Defronzo, Ralph A ; Banerji, Mary Ann ; 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. In: BMC Endocrine Disorders. 2009 ; Vol. 9.
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AU - Clement, Stephen

AU - Henry, Robert R.

AU - Kitabchi, Abbas E.

AU - Mudaliar, Sunder

AU - Musi, Nicolas

AU - Ratner, Robert

AU - Reaven, Peter D.

AU - Schwenke, Dawn

AU - Stentz, Frankie B.

AU - Tripathy, Devjit

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N2 - 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, 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 ≥ 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.

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