| Primary | Liver Histology (Using Kleiner et al Criteria, Hepatology 2005) | Number of patients with reduction of at least 2 points in the nonalcoholic fatty liver disease activity score (NAS) (with reduction in at least 2 different histological categories) without worsening of fibrosis. NAS is the sum of the separate scores for steatosis (0-3), hepatocellular ballooning (0-2) and lobular inflammation (0-3), and ranges from 0-8 . The scoring system is based on the following grading: Steatosis: 0 = <5%; 1 = 5-33%; 2 = >33-66%; 3 = >66%. Lobular Inflammation: 0 = No foci 1 = <2 foci/200x; 2 = 2-4 foci/200x, 3 = >4 foci/200x. Hepatocyte Ballooning: 0 = None; 1 = Few balloon cells; 2 = Many cells/prominent ballooning. Fibrosis: 0 = None; 1 = Perisinusoidal or periportal; 2 = Perisinusoidal and portal/periportal; 3 = Bridging fibrosis, 4 = Cirrhosis. | | Posted | | Count of Participants | | Participants | | At 18 months | | | | ID | Title | Description |
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| OG000 | Placebo | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm. | | OG001 | Pioglitazone | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose. |
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| Secondary | Number of Participants With Resolution of NASH | Resolution of NASH was defined as absence of NASH after 18 months of therapy in patients with definite NASH (presence of zone 3 accentuation of macrovesicular steatosis of any grade, hepatocellular ballooning of any degree, and lobular inflammatory infiltrates of any amount) at baseline. | Multiple imputation was used to impute missing histologic data for patients who did not complete 18 months of therapy. | Posted | | Count of Participants | | Participants | | Month 18 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm. | | OG001 | Pioglitazone | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose. |
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| Secondary | Mean Individual Histological Scores | Mean change in individual scores compared to baseline. Steatosis: 0 = <5%; 1 = 5-33%; 2 = >33-66%; 3 = >66%. Lobular Inflammation: 0 = No foci 1 = <2 foci/200x; 2 = 2-4 foci/200x, 3 = >4 foci/200x. Hepatocyte Ballooning: 0 = None; 1 = Few balloon cells; 2 = Many cells/prominent ballooning. Fibrosis: 0 = None; 1 = Perisinusoidal or periportal; 2 = Perisinusoidal and portal/periportal; 3 = Bridging fibrosis, 4 = Cirrhosis | Multiple imputation was used to impute missing histologic data for patients who did not complete 18 months of therapy. | Posted | | Mean | 95% Confidence Interval | units on a scale | | Baseline and Month 18 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm. | | OG001 | Pioglitazone | |
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| Secondary | Individual Histological Scores | Number of patients with improvement of at least 1 grade in each of the histological parameters. Steatosis: 0 = <5%; 1 = 5-33%; 2 = >33-66%; 3 = >66%. Lobular Inflammation: 0 = No foci 1 = <2 foci/200x; 2 = 2-4 foci/200x, 3 = >4 foci/200x. Hepatocyte Ballooning: 0 = None; 1 = Few balloon cells; 2 = Many cells/prominent ballooning. Fibrosis: 0 = None; 1 = Perisinusoidal or periportal, 1A = Mild, zone 3, perisinusoidal "delicate" fibrosis; 1B = Moderate, zone 3, perisinusoidal "dense" fibrosis; 1C = Portal/periportal; 2 = Perisinusoidal and portal/periportal; 3 = Bridging fibrosis, 4 = Cirrhosis | Multiple imputation was used to impute missing histologic data for patients who did not complete 18 months of therapy. | Posted | | Count of Participants | | Participants | | Month 18 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm. | |
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| Secondary | Mean Individual Histological Scores | Steatosis: 0 = <5%; 1 = 5-33%; 2 = >33-66%; 3 = >66%. Lobular Inflammation: 0 = No foci 1 = <2 foci/200x; 2 = 2-4 foci/200x, 3 = >4 foci/200x. Hepatocyte Ballooning: 0 = None; 1 = Few balloon cells; 2 = Many cells/prominent ballooning. Fibrosis: 0 = None; 1 = Perisinusoidal or periportal; 2 = Perisinusoidal and portal/periportal; 3 = Bridging fibrosis, 4 = Cirrhosis | | Posted | | Mean | 95% Confidence Interval | units on a scale | | Month 36 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm. | | OG001 | Pioglitazone | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose. |
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| Secondary | Liver Transaminases (AST and ALT). | | Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group), 83 at month 18 (42 and 41, respectively), and 63 at month 36 (29 and 34, respectively). | Posted | | Mean | Standard Deviation | U/L | | 18 and 36 months | | | | ID | Title | Description |
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| OG000 | Placebo | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm. | | OG001 | Pioglitazone | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose. |
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| Secondary | Liver Fat by Magnetic Resonance and Spectroscopy (MRS). | Liver fat content was calculated as the fat fraction: 100*(area under the curve [AUC] of fat peak / [AUC of fat peak + AUC of water peak]). | Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group) and 83 at month 18 (42 and 41, respectively). | Posted | | Mean | Standard Deviation | percentage of fat in liver | | 18 months | | | | ID | Title | Description |
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| OG000 | Placebo | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm. | | OG001 | Pioglitazone | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose. |
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| Secondary | Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | Homeostatic model assessment of insulin resistance (HOMA-IR) is a method for assessing insulin resistance (IR) from basal fasting plasma glucose (FPG) and fasting plasma insulin (FPI). It is calculated as (FPG x FPI)/405. | Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group), 83 at month 18 (42 and 41, respectively), and 63 at month 36 (29 and 34, respectively). | Posted | | Mean | 95% Confidence Interval | Arbitrary units | | 18 and 36 months | | | | ID | Title | Description |
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| OG000 | Placebo | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm. | | OG001 | Pioglitazone | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose. |
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| Secondary | Hepatic Insulin Sensitivity | Suppression of endogenous glucose production (Supp EGP) by low dose insulin (i.e., percentage of reduction of EGP with low dose insulin infusion compared to the baseline state). This was calculated as: 100*((EGP without insulin - EGP with insulin infusion)/EGP without insulin). All measurements are obtained at the same time point during an euglycemic insulin clamp. | Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group) and 83 at month 18 (42 and 41, respectively). | Posted | | Mean | 95% Confidence Interval | % of suppression of EGP | | 18 months | | | | ID | Title | Description |
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| OG000 | Placebo | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm. | | OG001 | Pioglitazone | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose. |
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| Secondary | Adipose Tissue Insulin Sensitivity | Suppression of free fatty acids by low dose insulin (i.e., percentage of reduction of plasma FFA with low dose insulin infusion compared to the baseline state). This was calculated as: 100*((plasma FFA without insulin - plasma FFA with insulin infusion)/plasma FFA without insulin). All measurements are obtained at the same time point during an euglycemic insulin clamp. | Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group) and 83 at month 18 (42 and 41, respectively). | Posted | | Mean | 95% Confidence Interval | % of suppression of FFA | | 18 months | | | | ID | Title | Description |
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| OG000 | Placebo | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm. | | OG001 | Pioglitazone | |
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| Secondary | Skeletal Muscle Insulin Sensitivity | Rate of glucose disappearance (Rd) during high-dose insulin infusion. The rate of plasma glucose disappearance was calculated using Steele's non-steady-state equation. | Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group) and 83 at month 18 (42 and 41, respectively). | Posted | | Mean | 95% Confidence Interval | mg/kgLBM/min | | 18 months | | | | ID | Title | Description |
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| OG000 | Placebo | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm. | | OG001 | Pioglitazone | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose. |
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| Secondary | Body Mass Index (BMI) | | Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group), 83 at month 18 (42 and 41, respectively), and 63 at month 36 (29 and 34, respectively). | Posted | | Mean | Standard Deviation | kg/m^2 | | Months 18 and 36 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm. | | OG001 | Pioglitazone | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose. |
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| Secondary | Total Body Fat | Total body fat measured by dual-energy x-ray absorptiometry (DXA) | Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group), 83 at month 18 (42 and 41, respectively). | Posted | | Mean | Standard Deviation | Percentage of body weight that is fat | | Months 18 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm. | | OG001 | Pioglitazone | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose. |
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| Secondary | Plasma Biomarkers Relevant to Hepatic Inflammation, Apoptosis and Fibrosis (Adiponectin). | | Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group), 83 at month 18 (42 and 41, respectively), and 63 at month 36 (29 and 34, respectively). | Posted | | Mean | 95% Confidence Interval | μg/ml | | 18 and 36 months | | | | ID | Title | Description |
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| OG000 | Placebo | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm. | | OG001 | Pioglitazone | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose. |
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| Secondary | Plasma Biomarkers Relevant to Hepatic Inflammation, Apoptosis and Fibrosis (CK-18). | | Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group), 83 at month 18 (42 and 41, respectively), and 63 at month 36 (29 and 34, respectively). | Posted | | Mean | 95% Confidence Interval | U/L | | 18 and 36 months | | | | ID | Title | Description |
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| OG000 | Placebo | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm. | | OG001 | Pioglitazone | Participants were prescribed a hypocaloric diet (500- kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose. |
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| Secondary | Prevention of the Onset of T2DM and/or Reversal From IFG/IGT to NGT in Non-diabetics. | Number of patients developing T2DM and number of patients regressing to NGT among patients with prediabetes (IFG/IGT). | Only patients with prediabetes are included in this analysis | Posted | | Count of Participants | | Participants | | 18 months | | | | ID | Title | Description |
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| OG000 | Pioglitazone | After all patients receive dietary counseling at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated). Pioglitazone study drug: 30 mg per day orally for 8 weeks, and if well tolerated, titrated to 45 mg per day until the end of 18 months Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design. | | OG001 | Placebo | After dietary counseling to all patients at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated). Placebo: An oral tablet identical to pioglitazone will be given once daily but without active drug for 18 months. Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design. |
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| Secondary | Osteoporotic Fractures | Number of patients with osteoporotic fractures | | Posted | | Count of Participants | | Participants | | 18 and 36 months | | | | ID | Title | Description |
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| OG000 | Pioglitazone | After all patients receive dietary counseling at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated). Pioglitazone study drug: 30 mg per day orally for 8 weeks, and if well tolerated, titrated to 45 mg per day until the end of 18 months Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design. | | OG001 | Placebo | After dietary counseling to all patients at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated). Placebo: An oral tablet identical to pioglitazone will be given once daily but without active drug for 18 months. Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design. |
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| Secondary | Molecular Pathways of Liver Glucose and Lipid Signaling; Inflammatory Pathways; Oxidative Stress; Other. | | | Posted | | | | | | At 18 (2nd liver biopsy) and 36 (3rd liver biopsy) months. | | | | ID | Title | Description |
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| OG000 | Pioglitazone | After all patients receive dietary counseling at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated). Pioglitazone study drug: 30 mg per day orally for 8 weeks, and if well tolerated, titrated to 45 mg per day until the end of 18 months Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design. | | OG001 | Placebo | After dietary counseling to all patients at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated). Placebo: An oral tablet identical to pioglitazone will be given once daily but without active drug for 18 months. Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design. |
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| Secondary | Bone Mineral Density | Bone mineral density measured at the levels of spine, femoral neck, hip, and wrist by DXA. | Data analysis included 78 patients at month 18 and 62 at month 36 (based on DXA availability). | Posted | | Mean | Standard Deviation | g/cm^2 | | 18 and 36 months | | | | ID | Title | Description |
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| OG000 | Pioglitazone | After all patients receive dietary counseling at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated). Pioglitazone study drug: 30 mg per day orally for 8 weeks, and if well tolerated, titrated to 45 mg per day until the end of 18 months Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design. | | OG001 | Placebo | After dietary counseling to all patients at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated). Placebo: An oral tablet identical to pioglitazone will be given once daily but without active drug for 18 months. Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design. |
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