Downhill hiking improves low-grade inflammation, triglycerides, body weight and glucose tolerance.

Exercise is a well-established tool for cardiovascular risk reduction. Particularly eccentric exercise, which essentially means walking downwards could favour more people becoming physically active. With the present controlled study, we tested the hypothesis that eccentric exercise can improve insulin sensitivity, triglyceride handling, body mass index, glucose tolerance and inflammation. We allocated 127 healthy sedentary individuals to one of two groups: (i) an active group of 102 individuals walking downwards a predefined route three to five times per week over two months, covering a difference in altitude of 540 m; for the upward route a cable car was used, for which adherence was recorded electronically and (ii) a matched control group of 25 individuals who stayed sedentary. Fasting and postprandial metabolic profiles were obtained at baseline and after two months. Compared to baseline, eccentric exercise significantly improved HOMA insulin resistance (1.94 ± 1.65 vs. 1.71 ± 1.36 (µU-1 ml) × ((mmol/l)-122.5); p = 0.038) and resulted in a decrease in fasting glucose (97 ± 15 vs. 94 ± 9 mg dl-1; p = 0.025) and glucose tolerance (238 ± 50 vs. 217 ± 47 mg dl-1 h-1; p < 0.001), whereas these parameters did not change significantly in the control group. Eccentric exercise significantly improved triglyceride tolerance (1923 ± 1295 vs. 1670 ± 1085 mg dl-1 h-1; p = 0.003), whereas triglyceride tolerance remained unchanged in the control group (p = 0.819). Furthermore, body mass index (27.7 ± 4.3 vs. 27.4 ± 4.3 kg m-2; p = 0.003) and C-reactive protein (0.27 ± 0.42 vs. 0.23 ± 0.25 mg dl-1; p = 0.031) were significantly lowered in the eccentric exercise group but not in the control group. Downhill walking, a type of exercise is a promising unusual exercise modality with favorable effects on body mass index, insulin action, on postprandial glucose and triglyceride handling and on C-reactive protein.ClinicalTrials.gov Identifier: NCT00386854.

The age of randomized clinical trials: three important aspects of randomized clinical trials in cardiovascular pharmacotherapy with examples from lipid, diabetes, and antithrombotic trials.

This review article aims to explain the important issues that data safety monitoring boards (DSMB) face when considering early termination of a trial and is specifically addressed to the needs of clinical and research cardiologists. We give an insight into the overall background and then focus on the three principal reasons for stopping trials, i.e. efficacy, futility, and harm. The statistical essentials are also addressed to familiarize clinicians with the key principles. The topic is further highlighted by numerous examples from lipid trials and antithrombotic trials. This is followed by an overview of regulatory aspects, including an insight into industry-investigator interactions. To conclude, we summarize the key elements that are the basis for a decision to stop a randomized clinical trial (RCT).

Sex-hormone-binding globulin is negatively correlated with femoral bone-mineral density in male cardiac-transplant recipients.

BACKGROUND: Osteoporosis and the subsequent increase in incidence of fractures are a common problem after cardiac transplantation. DESIGN: We performed a cross-sectional evaluation of male cardiac-transplant recipients in a late post-transplantation period (4.2 +/- 2.6 years after cardiac transplantation, n = 21). Bone-mineral density was measured by dual-energy X-ray absorptiometry and by quantitative heel ultrasound, and the endocrine characteristics of cardiac-transplant recipients with and without vertebral fractures were investigated. RESULTS: A significant negative correlation was observed between sex-hormone-binding globulin and femoral-neck bone-mineral density (rs = -0.699; p value = 0.001). Linear regression analysis controlling for age and body-mass index proved sex-hormone-binding globulin to be an independent negative predictor for femoral-neck bone-mineral density (r = -0.474; p value = 0.035). Patients with vertebral fractures had significantly lower femoral-neck bone-mineral density (pvalue = 0.035). However, sex-hormone-binding globulin, total and free testosterone, and estradiol did not exhibit significant associations with vertebral fractures in our patients. CONCLUSION: This investigation demonstrates for the first time an association between high sex-hormone-binding globulin levels and low femoral-neck bone-mineral density in a cohort of male cardiac-transplant recipients. Our data support the important role of sex-hormone-binding globulin in the pathogenesis of post-transplantation bone disease, although--possibly because of the small number of patients--we could not prove an interrelation of sex-hormone-binding globulin with vertebral fractures.