ELUCIDATE Trial: A Single-Center Randomized Controlled Study.

BACKGROUND: Dapagliflozin, a sodium-glucose cotransporter 2 inhibitor, is an epochal oral antidiabetic drug that improves cardiorenal outcomes. However, the effect of early dapagliflozin intervention on left ventricular (LV) remodeling in patients with type 2 diabetes free from cardiovascular disease remains unclear. METHODS AND RESULTS: The ELUCIDATE trial was a prospective, open-label, randomized, active-controlled study that enrolled 76 patients with asymptomatic type 2 diabetes with LV ejection fraction ≥50%, randomized to the dapagliflozin 10 mg/day add-on or standard-of-care group. Speckle-tracking echocardiography-based measurements of the cardiac global longitudinal strain were performed at baseline and 24 weeks after treatment initiation. Patients who received dapagliflozin had a greater reduction in LV dimension (1.68 mm [95% CI, 0.53-2.84]; P=0.005), LV end-systolic volume (5.51 mL [95% CI, 0.86-10.17]; P=0.021), and LV mass index (4.25 g/m2.7 [95% CI, 2.42-6.09]; P<0.0001) compared with standard of care in absolute mean differences. Dapagliflozin add-on therapy led to a significant LV global longitudinal strain increment (0.74% [95% CI, 1.00-0.49]; P<0.0001) and improved LV systolic and early diastolic strain rates (0.27/s [95% CI, 0.17-0.60]; and 0.11/s [95% CI, 0.06-0.16], respectively; both P<0.0001) but not in global circumferential strain. No significant changes were found in insulin resistance, NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels, or other biomarkers at 6 months after the dapagliflozin administration. CONCLUSIONS: Dapagliflozin add-on therapy could lead to more favorable cardiac remodeling accompanied by enhanced cardiac mechanical function among patients with asymptomatic type 2 diabetes. Our findings provide evidence of the efficacy of dapagliflozin use for the primary prevention of diabetic cardiomyopathy. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03871621.

High left ventricular mass associated with increased risk of incident diabetes.

Evidence for the role of electrocardiography or echocardiography in determining left ventricular hypertrophy for the risk of diabetes is still controversial. We aimed to explore whether left ventricular mass, as measured by these methods, is associated with the risk of diabetes in a community population. We recruited 2696 participants aged 35 years or older without diabetes who had undergone screening with electrocardiography and echocardiography. Left ventricular mass index (LVMI) was calculated using a formula, and participants were divided into tertiles based on their LVMI tertiles. During a median follow-up period of median, 8.9 years, a total of 405 participants developed diabetes. The incidence and risk of diabetes significantly increased with higher LVMI tertiles. Multivariate Cox regression analysis demonstrated that individuals in the highest LVMI tertile had a greater likelihood of developing incident diabetes, with a hazard ratio of 1.40 (95% CI 1.06-1.91), even after adjusting related covariates. The highest risk of diabetes was observed in the presence of both the uppermost LVMI tertile and electrocardiographically determined left ventricular hypertrophy for the Chinese population. Left ventricular hypertrophy identified by either electrocardiography or echo may serve as a surrogate marker for identifying the risk of diabetes in clinical practice.

Association between thyroid cancer and cardiovascular disease: A meta-analysis.

Objective: To determine the association between thyroid cancer and coronary artery disease, atrial fibrillation, cerebrovascular disease, and cardiovascular disease mortality. Methods: The PubMed, Embase, and Cochrane Library databases were searched for eligible studies from inception to September 22, 2022. Keywords included "thyroid cancer", "atrial fibrillation", "coronary artery disease", "cerebrovascular disease", and "mortality". Primary outcomes included the incidence of coronary artery disease, cerebrovascular disease, atrial fibrillation, and cardiovascular disease mortality among patients with thyroid cancer. Secondary outcomes included cardiovascular disease events among those with thyroid cancer that received or did not receive radioactive iodine or lenvatinib. Estimates were pooled using fixed- and random-effects meta-analysis. Results: A total of 771,220 patients who underwent thyroidectomy in 15 studies were included. Risk for cerebrovascular disease (risk ratio [RR] 1.15 [95% confidence interval (CI) 1.10-1.21]) and atrial fibrillation [RR 1.59 (95% CI: 1.45-1.73)] were significantly increased. Risk for coronary artery disease was significantly increased [RR 1.12 (95% CI: 1.08-1.17)] in the common effect model. Cardiovascular disease mortality associated with thyroid cancer was not significant [RR 0.93 (95% CI: 0.59-1.45)]. Radioactive iodine had a neutral effect on cardiovascular disease [RR 1.00 (95% CI: 0.87-1.16)], and there was no beneficial nor harmful effect among different RAI doses. Conclusions: Thyroid cancer was significantly associated with a higher risk for cerebrovascular disease and atrial fibrillation; however, the hazard risk was not different between patients with and without radioactive iodine treatment. Thyroid cancer treatment should be individualized considering the potential harms and benefits to cardiovascular health.

Comparison of two titration programmes for adding insulin detemir to oral antidiabetic drugs in patients with poorly controlled type 2 diabetes mellitus.

AIM: To explore the effect of active insulin titration versus usual titration on glycaemic control in patients with type 2 diabetes mellitus uncontrolled with oral antidiabetic drugs (OADs). METHODS: In a 24-week, prospective and randomized study, 172 patients with uncontrolled type 2 diabetes were randomly assigned to either active titration or usual titration. Efficacy and safety outcomes included changes in glycated haemoglobin (HbA1c) and fasting plasma glucose, percentage of individuals achieving HbA1c<53 mmol/mol, and hypoglycaemic events. RESULTS: At Week 24, change in HbA1c was -1.08% ± 1.60% in the active titration group and -0.95% ± 1.34% in the usual titration group (P = 0.569). The percentages of individuals achieving HbA1c<53 mmol/mol were 29.4% and 16.1% in the active and usual titration groups, respectively (P = 0.037). There was no significant difference in the incidence of hypoglycaemia between the two groups. Multivariate logistic regression indicated that, with active titration, baseline HbA1c levels and postprandial glucose excursion were significantly associated with achieving HbA1c<53 mmol/mol. CONCLUSION: Addition of basal insulin using active titration for 24 weeks provided a higher rate of HbA1c target achievement without significant hypoglycaemia compared to usual titration in individuals with uncontrolled type 2 diabetes.

Association between thyroid cancer and cardiovascular disease risk: a nationwide observation study.

Treatment with levothyroxine and radioiodine contribute alternative cardiovascular function in adults with thyroid cancer. The risks of long-term cardiovascular conditions among thyroid cancer patients is unknown. This study aimed to compare the incidence of coronary heart disease (CHD), ischemic stroke (IS), and atrial fibrillation (AF) among adults with thyroid cancer with that of the general population, especially when stratified by age (< 65 and ≥ 65 years old). This observational cohort study enrolled patients between January 1, 2011 and December 31, 2016 with a follow-up until December 31, 2018. This study analyzed the data of Taiwanese thyroid cancer patients registered on the National Taiwan Cancer Registry Database, with CHD and IS. SIR models were used to evaluate the association between thyroid cancer and CHD, IS, AF, and cardiovascular disease outcome, stratified by age and sex. SIR analyses were also conducted for both sexes, age groups (< 65, ≥ 65 years), and different follow-up years. After excluding 128 individuals (< 20 years or ≥ 85 years old) and with missing index data, 4274 eligible thyroid cancer patients without CHD history, 4343 patients without IS history, and 4247 patients without AF history were included for analysis. During the median follow-up of 3.5 (1.2) years among thyroid cancer patients, the observed number of new CHD events was 70; IS, 30; and AF, 20, respectively. The SIR was significantly higher for CHD (SIR, 1.57; 95% confidence interval [CI] 1.2-1.93) among thyroid cancer patients compared with the age- and sex-specific standardized population. However, the association between thyroid cancer and the risks of IS (SIR, 0.74; 95% CI 0.47-1), cardiovascular disease (SIR, 0.88; 95% CI 0.7-1.05), and atrial fibrillation (SIR, 0.74; 95% CI 0.42-1.06) were insignificant. Moreover, stratification by age < 65 or age ≥ 65 years old and by sex for CHD suggested that the diagnosis of thyroid cancer in the young may attenuate the CHD risk (SIR, 2.08; 95% CI 1.5-2.66), and the CVD risk was constant among both men (SIR, 1.63; 95% CI 1.03-2.24) and women (SIR, 1.53; 95% CI 1.06-1.99). The patients had persistent higher CHD risk for 5 years after cancer diagnosis. Thyroid cancer survivors have a substantial CHD risk, even at long-term follow-up, especially in those patients < 65 years old. Further research on the association between thyroid cancer and CHD risk is warranted.

Effect of empagliflozin versus linagliptin on body composition in Asian patients with type 2 diabetes treated with premixed insulin.

Insulin therapy often increases body weight and leads to visceral fat accumulation. Progression in diabetes is also associated with accelerated loss of muscle mass. Little is known about body composition changes in type 2 diabetes mellitus (T2DM) patients on insulin therapy who use sodium-glucose cotransporter-2 (SGLT2) inhibitors versus dipeptidyl peptidase-4 (DPP4) inhibitors. This study examined the effect of 25 mg of empagliflozin compared with 5 mg of linagliptin for 24 weeks on body weight and body composition in patients with T2DM on premixed insulin. Body composition was assessed with bioelectrical impedance analysis. The mean difference between the linagliptin and empagliflozin groups in terms of mean body weight change from baseline to 24 weeks was - 1.80 kg (95% CI - 2.57, - 1.03). Empagliflozin also significantly reduced muscle mass (- 1.39 kg, 95% CI - 2.49, - 0.29) and total body water (- 1.07 kg, 95% CI - 1.88, - 0.27) compared with linagliptin. Compared to linagliptin, empagliflozin decreased body fat mass more from baseline to week 24, but this was not significant (- 0.31 kg, 95% CI - 1.51, 0.90). Further research on insulin-treated T2DM patients is necessary to investigate the long-term effects of SGLT2 and DPP4 inhibitors on body composition, as well as their effects on muscle strength and physical function.Trial registration: ClinicalTrials.gov no. NCT03458715, registration date: March 8, 2018.

Effects of SGLT2 inhibitors on stroke and its subtypes in patients with type 2 diabetes: a systematic review and meta-analysis.

Sodium-glucose cotransporter 2 (SGLT2) inhibitors have shown impressive effects in reducing major vascular events in several randomized controlled trials (RCTs). The purpose of this study was to perform a meta-analysis to evaluate the effect of SGLT2 inhibitors on the risk of stroke and its subtypes. All data from prospective RCTs up to 20 October 2020 involving SGLT2 inhibitors that reported stroke events as the primary endpoint or safety in subjects with type 2 diabetes were subjected to meta-analysis. Five eligible RCTs (EMPA-REG, CANVAS, DECLARE-TIMI 58, CREDENCE and VERTIS CV) involving 46,969 participants were included. Pooled analysis of the RCTs showed no significant effect of SGLT2 inhibitors on total stroke [risk ratio (RR) = 0.95; 95% confidence interval (CI) 0.79-1.13, P = 0.585]. Subgroup analysis indicated that SGLT2 inhibitors had no significant effect against fatal stroke, non-fatal stroke, ischemic stroke or transient ischemic attack. When only hemorrhagic stroke was included, SGLT2 inhibitors were associated with a significant 50% reduction compared with placebo (RR = 0.49, 95% CI 0.30-0.82, P = 0.007). This meta-analysis shows that SGLT2 inhibitors have a neutral effect on the risk of stroke and its subtypes but a potential protective effect against hemorrhagic stroke.

Combined healthy lifestyle factors are more beneficial in reducing cardiovascular disease in younger adults: a meta-analysis of prospective cohort studies.

To determine the association between combined lifestyle factors, including healthy diet, moderate alcohol consumption, non-smoking, physical activity, and optimal weight, and cardiovascular disease (CVD) risk among younger and older adults. We conducted a literature search using PubMed, EMBASE, Cochrane Library, and EBSCO databases up to November 30, 2019 and performed dose-response analysis, subgroup analysis and meta-regression with odds ratios and 95% confidence intervals (CIs). Twenty cohort studies involving 1,090,261 participants with 46,288 cardiovascular events and mean follow-up duration of 12.33 years were included. Compared with the group with the lowest number of healthy lifestyle factors, the group with the highest number had lower CVD risk [pooled hazard ratio, 0.37 (95% CI 0.31-0.43)]. With age as an effect modifier, the lifetime risk of CVD was 0.31 (95% CI 0.24-0.41) at age 37.1-49.9 years, 0.36 (95% CI 0.30-0.45) at age 50.0-59.9 years and 0.49 (95% CI 0.38-0.63) at age 60.0-72.9 years. The hazard ratio of CVD significantly increased from 37.1 to 72.9 years of age [slope in multivariate meta-regression: 0.01 (95% CI < 0.001-0.03; p = 0.042)]. Younger adults have more cardiovascular benefits from combined healthy lifestyle factors.

High pulse wave velocity is associated with the severity of diabetic retinopathy in patients with type 2 diabetes.

Pulse wave velocity (PWV) is a non-invasive test for assessing arterial stiffness, and brachial-ankle PWV has been used as an index of peripheral arterial stiffness. This study aimed to investigate the association between the PWV value and severity of diabetic retinopathy (DR). 846 patients with type 2 diabetes (T2DM) consecutively underwent brachial-ankle PWV, and the degree of PWV was defined by tertile. The severity of DR was categorized as no diabetic retinopathy (NDR), non-proliferative diabetic retinopathy (NPDR) or proliferative diabetic retinopathy (PDR) based on the Early Treatment Diabetic Retinopathy Study Scale. Multinomial logistic regression analyses were utilized not only to explore the association between the degree of PWV and severity of DR but also to examine the association of a high-tertile PWV with PDR. PWV levels, diabetes duration and blood pressure were all significantly higher in subjects with NPDR or PDR as compared with individuals with NDR. In the univariate analysis, the highest tertile of PWV (>19.6 m/s) was significantly associated with both NPDR (p<0.001) and PDR (p<0.001) as compared with NDR. After adjusting for confounding factors, the highest tertile of PWV remained significantly associated with PDR (p=0.005), but not with NPDR (p=0.107). Furthermore, the highest tertile of PWV was more significantly associated with PDR (OR=6.15, 95%CI 1.38 to 27.38) as compared with the lowest tertile. In our study, an increasing degree of PWV was positively associated with the severity of DR. High PWV was strongly associated with the risk of severe DR, especially PDR.

Addition of Metabolic Syndrome to Albuminuria Provides a New Risk Stratification Model for Diabetic Kidney Disease Progression in Elderly Patients.

Elderly patients with type 2 diabetes (T2DM) are more prone to developing diabetic kidney disease (DKD). Patients with DKD can develop albuminuria, and some studies have suggested an association between metabolic syndrome and albuminuria. The prevalence of both metabolic syndrome and albuminuria increases with age. We evaluated the association of these risk factors with worsening renal function and albuminuria progression in 460 T2DM patients with a mean age of 72 years. During the 5-year follow-up period, progression of albuminuria and worsening of renal function were observed in 97 (21.2%) and 23 (5.1%) patients, respectively. After adjusting for confounding factors, the group with metabolic syndrome had a higher multivariable-adjusted hazard ratio (HR) for worsening renal function (P = 0.038) and albuminuria progression (P = 0.039) than the group without metabolic syndrome. When patients were divided into four groups according to the presence of metabolic syndrome and/or albuminuria, the HR gradually increased. The group with both albuminuria and metabolic syndrome exhibited the highest cumulative incidence of worsening renal function (P = 0.003). When we redefined metabolic syndrome to exclude the blood pressure (BP) component, similar results were obtained. We concluded that the presence of metabolic syndrome independently predicts the progression of renal disease in elderly patients with T2DM. The use of both metabolic syndrome and albuminuria provides a better risk stratification model for DKD progression than albuminuria alone.

Relationships between chronic comorbidities and the atherosclerosis indicators ankle-brachial index and brachial-ankle pulse wave velocity in patients with type 2 diabetes mellitus.

This study aimed to determine associations between ankle-brachial index (ABI) and brachial-ankle pulse wave velocity (baPWV) with different comorbidities in patients with type 2 diabetes mellitus (DM). Records of patients with type 2 DM who received an ABI and baPWV examination between August 2013 and February 2015 were retrospectively reviewed. Associations of ABI and baPWV with chronic kidney disease (CKD), chronic liver disease (CLD), coronary artery disease (CAD) and diabetic nephropathy (DN) were examined by regression analysis. A total of 1232 patients (average age, 65.1±10.0 years) were included in the analysis. CKD and DN were associated with low ABI and increased baPWV (all, P<0.001). No associations were found between CAD and CLD and ABI or baPWV. Thus, regression analysis was performed for CKD and DN. Low ABI was associated with risk of CKD in the crude model (OR 0.724, 95% CI 0.648 to 0.808, P<0.001) and adjusted model (OR 0.872, 95% CI 0.762 to 0.999, P=0.048), whereas baPWV was only significant in the crude model (OR 1.199, 95% CI 1.112 to 1.294, P<0.001). Low ABI was associated with risk of DN in the crude model (OR 0.873, 95% CI 0.780 to 0.977, P=0.018) and adjusted model (OR 0.884, 95% CI 0.782 to 0.999, P=0.048). No association was found for baPWV. In conclusion, low ABI was associated with risk of CKD and DN in patients with type 2 diabetes.

Synergistic Effect of Hyperglycemia and Helicobacterpylori Infection Status on Colorectal Adenoma Risk.

Context: Both Helicobacter pylori and type 2 diabetes mellitus are possible risk factors for colon adenoma. Objective: The purpose of this study was to assess the interaction between H. pylori and hyperglycemia status on the risk of colon adenoma. Design, Setting, and Participants: This was a cross-sectional, retrospective study conducted at the MacKay Memorial Hospital, Taiwan. The study included 3943 subjects aged >40 years undergoing bidirectional gastrointestinal endoscopy on the same day between July 2006 and June 2015. All subjects had a gastric biopsy specimen tested for H. pylori. Main Outcome Measure: Colon adenoma with and without H. pylori infection at different hemoglobin A1c (HbA1c) levels. Results: The prevalence of colorectal adenomas in patients who were H. pylori-positive and H. pylori-negative was 37.3% and 27.29%, respectively. Multivariate logistic regression analysis identified male sex, age, body mass index, H. pylori infection, and HbA1c ≥6.5% as independent risk factors for adenoma; use of hypoglycemic agents decreased this risk. The prevalence of adenoma was increased with elevated HbA1c levels regardless of H. pylori status. The odds ratio (OR) for adenoma was 1.44 (95% confidence interval [CI], 1.20 to 1.73) if H. pylori was present or 1.68 (95% CI, 1.05 to 2.70) in patients who were H. pylori-negative but had HbA1c ≥7.0%. If both conditions were present, the OR was 4.79 (95% CI, 2.92 to 7.84). A 1% increase in HbA1c was associated with an increased prevalence of adenoma by 42.4% in H. pylori-positive subjects. Conclusions: The combination of H. pylori infection and elevated HbA1c is associated with an increased risk of colon adenoma.

Quality of Life After Surgery or Surveillance for Asymptomatic Primary Hyperparathyroidism: A Meta-Analysis of Randomized Controlled Trials.

A number of studies have investigated the effects of surgery on symptoms and quality of life in patients with hyperparathyroidism. However, the results are inconsistent. We conducted this meta-analysis to quantitatively assess changes in quality of life among patients with asymptomatic primary hyperparathyroidism. Different databases were searched for randomized controlled trials comparing surgery with surveillance. Quality of life was measured by the Short Form-36 general health survey. The pooled random-effects estimates of standardized mean difference (SMD) and 95% confidence intervals (CIs) were calculated. Three trials involving 294 participants were included. At 1 year, patients undergoing parathyroidectomy had significantly better physical role functioning (SMD, 0.31; 95% CI 0.04-0.57; P = 0.02) and emotional role functioning (SMD, 0.29; 95% CI 0.02-0.55; P = 0.03). At 2 years, the surgery group had significantly better emotional role functioning (SMD, 0.35; 95% CI 0.02-0.67; P = 0.04) than the surveillance group. Furthermore, compared with baseline, emotional role functioning improved after surgery (SMD, 0.31; 95% CI 0.02-0.60; P = 0.04), whereas emotional role functioning tended to get worse in patients assigned to medical surveillance (SMD, -0.27; 95% CI -0.55 to 0.02; P = 0.07). Although Short Form-36 is a generic instrument, our results suggest that parathyroidectomy may be associated with better quality of life, especially in the emotional aspects of well-being.

Nonalcoholic fatty liver disease: updates in noninvasive diagnosis and correlation with cardiovascular disease.

Nonalcoholic fatty liver disease (NAFLD) refers to the accumulation of fat (mainly triglycerides) within hepatocytes. Approximately 20%-30% of adults in the general population in developed countries have NAFLD; this trend is increasing because of the pandemicity of obesity and diabetes, and is becoming a serious public health burden. Twenty percent of individuals with NAFLD develop chronic hepatic inflammation [nonalcoholic steatohepatitis (NASH)], which can be associated with the development of cirrhosis, portal hypertension, and hepatocellular carcinoma in a minority of patients. And thus, the detection and diagnosis of NAFLD is important for general practitioners. Liver biopsy is the gold standard for diagnosing NAFLD and confirming the presence of NASH. However, the invasiveness of this procedure limits its application to screening the general population or patients with contraindications for liver biopsy. The development of noninvasive diagnostic methods for NAFLD is of paramount importance. This review focuses on the updates of noninvasive diagnosis of NAFLD. Besides, we review clinical evidence supporting a strong association between NAFLD and the risk of cardiovascular disease because of the cross link between these two disorders.

Efficacy and safety of adding pioglitazone or sitagliptin to patients with type 2 diabetes insufficiently controlled with metformin and a sulfonylurea.

OBJECTIVE: To evaluate the efficacy and safety of add-on pioglitazone versus sitagliptin in patients with type 2 diabetes inadequately controlled on metformin and a sulfonylurea (SU). METHODS: This 24-week, randomized, open-label study compared pioglitazone (30 mg daily, n = 59) and sitagliptin (100 mg daily, n = 60) in patients with inadequate glycemic control (glycosylated hemoglobin [HbA1c] ≥7.0% to <11.0%) while receiving a stable dose of metformin (≥1,500 mg daily) and an SU (≥half-maximal dose). RESULTS: The mean changes in HbA1c from baseline was -0.94 ± 0.12% with pioglitazone and -0.71 ± 0.12% with sitagliptin, for a between-groups difference of -0.23 ± 0.16% (P = .16). The mean change in fasting plasma glucose (FPG) were -35.7 ± 4.0 mg/dL with pioglitazone and -22.8 ± 4.0 mg/dL with sitagliptin, for a between-groups difference of -12.9 ± 5.7 mg/dL (P = .02). Pioglitazone was associated with a significant decrease in high-sensitive C-reactive protein (hs-CRP), but sitagliptin did not. The mean weight gain was higher in the pioglitazone group, with a between-group difference of 1.6 kg (P<.01). Overall adverse events (AEs) were similar in both groups. However, the incidence of edema was higher with pioglitazone, and the incidence of gastrointestinal AEs was higher with sitagliptin. CONCLUSION: Pioglitazone and sitagliptin achieved similar improvements in overall glycemic control in patients with type 2 diabetes inadequately controlled with metformin and an SU. However there were some differences in terms of FPG, hs-CRP, lipids, body-weight change, and AEs.

Safety and effectiveness of rosiglitazone in type 2 diabetes patients with nonalcoholic Fatty liver disease.

BACKGROUND/PURPOSE: Nonalcoholic fatty liver disease (NAFLD) is a common chronic liver disease ranging in severity from steatosis to cirrhosis. Type 2 diabetes mellitus is a cause of primary NAFLD. Thiazolidinediones have been shown to enhance insulin sensitivity, improve glycemic control in type 2 diabetes patients and to improve the histologic markers of nonalcoholic steatohepatitis. This study aims to determine the safety and effectiveness of rosiglitazone in inadequately controlled type 2 diabetes patients with NAFLD. METHODS: Taiwanese type 2 diabetes patients with inadequate control on insulin secretagogues and metformin, with no history of significant alcohol ingestion, with mildly elevated serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and a diagnosis of fatty liver determined by ultrasonography were enrolled. Patients were treated for 24 weeks with rosiglitazone, 4-8 mg daily. Primary endpoints were change in AST and ALT levels from baseline and reduction in A1C < 6.5%. RESULTS: Out of a total of 68 patients, 60 (88.2%) completed the study treatment without serious adverse events. Treatment in two (2.9%) patients was discontinued due to elevated AST or ALT levels to more than three times the upper limit of normal, and noncompliance or loss of follow-up in six (8.8%) patients. Of the 60 patients who completed the study treatment, mean fasting plasma glucose, A1C, fasting plasma insulin, mean ALT and homeostasis model assessment for insulin resistance were all significantly reduced. Normal AST and ALT levels were achieved and maintained for at least three consecutive measurements and through to the end of the study period in 20 (33.3%) patients. Weight increased by a mean of 2.6 +/- 2.4 kg (p < 0.001). CONCLUSION: Rosiglitazone was reasonably well tolerated in patients with inadequately controlled type 2 diabetes and NAFLD. One-third of patients showed improved liver function after treatment.