Women’s involvement in clinical trials: historical perspective and future implications

The importance of considering the differences between the male and female sex in clinical decision-making is crucial. However, it has been acknowledged in recent decades that clinical trials have not always adequately enrolled women or analyzed sex-specific differences in the data. As these deficiencies have hindered the progress of understanding women’s response to medications, agencies in the United States have worked towards the inclusion of women in clinical trials and appropriate analysis of sex-specific data from clinical trials. This review outlines the history and progress of women’s inclusion in clinical trials for prescription drugs and presents considerations for researchers, clinicians, and academicians on this issue.

Dietary restraint and subjective well-being in university students in Chile

Objective: To characterize university students typologies according to chronic food restriction, satisfaction with life and food consumption. Materials and method: A questionnaire was applied on a non-probability sample of 369 male and female students from five Chilean universities. The questionnaire included: Revised Restraint Scale (RRS), Satisfaction with Life Scale (SWLS), Satisfaction with Food-related Life (SWFL) and the Health-related Quality of Life Index. The survey included food and drink consumption habits, weight and approximate height and sociodemographic variables. Results: Two factors in the RRS were detected by exploratory factor analysis: Preoccupation with Diet (PD) and Weight fluctuations (WF). A confirmatory factor analysis validated the bifactor structure of the RRS with an acceptable adjustment kindness. The cluster analysis allowed a distinction of four typologies with a significant variation in PD, WF, SWLS and SWFL scoring, number of days with mental health problems, frequency of alcoholic drinks consumption, restraint on the consumption of certain foods, drinks and spices, consumption frequency of fruit out of the main meals and types. Typologies did not differ on their body mass index. Conclusions: Both, students preoccupied with diet and those who are not, experience higher levels of satisfaction with life and with food. Lower levels of global life satisfaction and satisfaction with food are related with the fluctuations in weight.

Influence of magnesium on biochemical parameters of iron and oxidative stress in patients with type 2 diabetes

Introduction: Studies have shown that oxidative stress, found in patients with type 2 diabetes, may be due to changes in the metabolism of minerals, such as magnesium and iron. Data related to compartmentalization of these minerals in diabetes are scarce and controversial. Objective: This study assessed the influence of magnesium on biochemical parameters of iron and oxidative stress in patients with type 2 diabetes. Methods: A case-control study in male and female subjects aged 27-59 years, divided into two groups: type 2 diabetes (n=40) and control (n=48). Intake of magnesium and iron was assessed by three-day food record. Plasma, erythrocyte and urinary levels of magnesium, serum iron, ferritin, total iron binding capacity, fasting glucose, glycated hemoglobin, insulin, creatinine clearance and plasma thiobarbituric acid reactive substances (TBARS) were analyzed. Results and Discussion: Magnesium intake and plasma magnesium were lower in diabetic subjects. There was low urinary magnesium excretion, with no difference between groups. Although normal, the diabetic group had lower serum iron and ferritin concentrations compared to control subjects. Plasma TBARS in diabetic patients was higher than control while creatinine clearance was lower. An inverse correlation between erythrocyte magnesium and serum iron and ferritin was observed in the diabetes group. Conclusions: Diabetes induced hypomagnesemia and this, associated with chronic hyperglycemia, may have enhanced oxidative stress. Erythrocyte magnesium may have contributed to prevent iron overload and worsening of oxidative stress and hyperglycemic status.