Baseline Type 2 Diabetes Research Articles

Factors influencing longitudinal changes of circulating liver enzyme concentrations in subjects randomized to placebo in four clinical trials.

Liver enzyme concentrations are measured as safety end points in clinical trials to detect drug-related hepatotoxicity, but little is known about the epidemiology of these biomarkers in subjects without hepatic dysfunction who are enrolled in drug trials. We studied alanine and aspartate aminotransferase (ALT and AST) in subjects randomized to placebo who completed assessments over 36 mo in a cardiovascular outcome trial [the Stabilisation of Atherosclerotic Plaque by Initiation of Darapladib Therapy ("STABILITY") trial; n = 4,264; mean age: 64.2 yr] or over 12 mo in three trials that enrolled only subjects with type 2 diabetes (T2D) [the DIA trials; n = 308; mean age: 62.4 yr] to investigate time-dependent relationships and the factors that might affect ALT and AST, including body mass index (BMI), T2D, and renal function. Multivariate linear mixed models examined time-dependent relationships between liver enzyme concentrations as response variables and BMI, baseline T2D status, hemoglobin A1c levels, and renal function, as explanatory variables. At baseline, ALT was higher in individuals who were men, <65 yr old, and obese and who had glomerular filtration rate (GFR) >60 ml·min-1·1.73 m-2. ALT was not significantly associated with T2D at baseline, although it was positively associated with HbA1c. GFR had a greater impact on ALT than T2D. ALT concentrations decreased over time in subjects who lost weight but remained stable in individuals with increasing BMI. Weight change did not alter AST concentrations. We provide new insights on the influence of time, GFR, and HbA1c on ALT and AST concentrations and confirm the effect of sex, age, T2D, BMI, and BMI change in subjects receiving placebo in clinical trials. NEW & NOTEWORTHY Clinical trials provide high-quality data on liver enzyme concentrations from subjects randomized to placebo that can be used to investigate the epidemiology of these biomarkers. The adjusted models show the influence of sex, age, time, renal function, type 2 diabetes, HbA1c, and body mass index on alanine aminotransferase and aspartate aminotransferase concentrations and their relative importance. These factors need to be considered when assessing potential signals of hepatotoxicity in trials of new drugs and in clinical trials investigating subjects with nonalcoholic fatty liver disease.

Baseline type 2 diabetes had a significant association with elevated high sensitivity cardiac troponin T levels in Chinese community-dwelling population: a 5-year prospective analysis

BackgroundThe present analysis was designed to investigate the association of type 2 diabetes (T2D) with high sensitivity cardiac troponin T (hs-cTnT) during the 5 years of follow-up, and explore which one of fasting blood glucose (FBG) and postprandial blood glucose (PBG) is a determinant of this association in Chinese community-dwelling population.MethodsThis prospective community-based analysis was conducted based on 730 participants without coronary artery disease and hs-cTnT values ≥14 pg/mL receiving two measurements of hs-cTnT levels at baseline and follow-up of 5 years.ResultsPrevalence of T2D was 16.2% (118 participants). Median hs-cTnT levels were 4 (3-7) pg/mL and 6 (5-9) pg/mL at baseline and follow-up, respectively. The variation in hs-cTnT levels had a median of 2 (0-4) pg/ml (p < 0.001 for variation), and incidence of hs-cTnT levels ≥14 pg/ml was 7.1% (52 participants) at follow-up. T2D had a significant association with elevated hs-cTnT levels in multivariate Logistic regression models (p < 0.05). Elevated levels of PBG (p < 0.05) rather than FBG (p > 0.05) determined the significant association with elevated hs-cTnT levels in multivariate linear regression models.ConclusionsThis community-based analysis observed that there was a significant increment of hs-cTnT levels, and baseline T2D had a significant association with elevated hs-cTnT levels during the 5 years of follow-up. Moreover, the present analysis demonstrated that PBG rather than FBG played a crucial role in this association in Chinese community-dwelling population without CAD.

Control of type 2 diabetes after 1 year of laparoscopic adjustable gastric banding in the helping evaluate reduction in obesity (HERO) study.

The 5-year, open-label, prospective, observational helping evaluate reduction in obesity (HERO) study (N = 1106) examines efficacy and safety of the LAP-BAND AP(®) laparoscopic adjustable gastric band (LAGB) in obese patients. This interim analysis assessed the control of type 2 diabetes (T2D), 1 year after the implantation of the LAGB. Baseline T2D was defined by chart review or use of antidiabetic medications or haemoglobin A1c (HbA1c) ≥ 7.0%. Control of T2D at 1 year was defined as A1c <7.0% (with or without antidiabetic medications). After 1 year, 187 of 273 patients with T2D at baseline had adequate data available to assess T2D status, of which 135 patients (72.2%) achieved target control of T2D compared with 42.8% control rate at baseline. Independent predictors of achieving target control at 1 year included the following: (i) shorter diabetes duration odds ratio (OR) 0.914 [95% confidence interval (CI), 0.839, 0.995, p = 0.038], (ii) not using insulin therapy OR 0.16 (95% CI, 0.06, 0.47, p < 0.001) and (iii) greater mean % weight loss OR 1.176 (95% CI, 1.093, 1.266, p < 0.001). Patients using insulin at baseline were 84% less likely to achieve control of T2D after 1 year; each additional year of diabetes at baseline reduced the likelihood of good control by 9%; and each 1% of weight loss increases the likelihood of good control by 18%. Rates of device-related adverse events and reoperations were low and were not significantly different between patients with and without baseline T2D at 1 year. Greater % weight loss, not using insulin therapy, and shorter disease duration predicted increased likelihood of target control of T2D, 1 year after implantation of the LAGB.