2 Clinical Trials for Various Conditions
Evaluate the safety and immunogenicity of the trivalent group B streptococcus vaccine in healthy pregnant women. The study will also evaluate the levels of GBS serotype-specific antibodies in infants, placental transfer from the pregnant women to the infant and levels of antibodies in the breast milk.
This research is a NIH single site study with the aims to (1) determine whether surgically induced weight loss decreases the risk of CVD in morbidly obese subjects with T2DM. (2) elucidate the mechanisms by which surgically induced weight loss reduces over time the risk of CVD in morbidly obsess subjects with T2DM. Study'subjects will be enrolled from obese individuals with type 2 diabetes (T2DM). The study includes two groups, subjects undergoing gastric bypass surgery and a control group not undergoing weight loss surgery. A total of 60 subjects (30 in each group) will be recruited. Basal, 6 and 12 months assessments will include: insulin sensitivity determination, cardiovascular function by echo doppler, and DEXA scan. This study involves risk-level II procedures, however, the risks inherent to the gastric bypass surgery are not considered study-derived because subjects are enrolled from individuals that have already decided to have this surgery. We will determine protein expression profiles of inflammation-related adipokines in the subcutaneous and intra-abdominal adipose tissues of morbidly obese subjects with T2DM before and after surgically induced weight loss.