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IRB No. 22-327-1 (Dr. Biree Andemariam, PI): Bone Loss, Physical Function and Frailty in Older Women with Sickle Cell Trait

This research study has two purposes. The first purpose is to determine whether having sickle cell trait is a risk factor for the development of bone thinning in older women. Nearly 10% of African Americans carry sickle cell trait, and most of them are unaware of it. African Americans are less likely to develop thin bones than whites, but if they sustain a bone fracture, they are more likely to die from it. Having sickle cell trait may lead to bone thinning and predispose a subset of African Americans to dangerously thin bones. The second purpose is to investigate whether women with SCT have reduced decreased muscle function, decreased muscle mass, and increased frailty compared to women without SCT. Frailty is a common clinical syndrome in older adults that carries an increased risk for poor health outcomes, including falls, incident disability, hospitalization, and death. This study will try to fill a knowledge gap in the scientific literature. It may potentially reveal a previously unrecognized risk factor for disability and address potential health disparity in African descent women.

IRB No. 23-113-2 (Dr. Andrea Shields, PI): Assessing postpartum volume status using clinical, laboratory, and sonographic values in a cohort of normotensive versus preeclamptic women

The hypothesis of this study is that ultrasound measurements of vein diameter will correlate to clinical and laboratory based values that measure the amount of fluid in a person's circulation and body; we will specifically look at women who are postpartum in two groups -- women with no high blood pressure and women with preeclampsia. Our aims will be to: - Measure the diameter of the inferior vena cava with a portable ultrasound - Examine the patient and look for signs of volume status (i.e. swelling in the legs) - Perform routine labatory tests that will reflect the amount of circulating blood volume (brain natriuretic peptide) Our objectives will be to: - Examine whether the vein diameter correlated with the level of brain natriuretic peptide - Examine whether there are differences in all values collected between the no high blood pressurs vs. preeclampsia population - In the preeclamptic population, collect 2-3 days of data so changes that occur longitudinally can also be examined.

IRB No. 23-179-1 (Dr. Andrea Shields, PI): Xenobiotic transfer of Tranexamic acid (TXA) using an ex vivo placental perfusion model: a pilot study

To our knowledge, there are no studies that have researched if tranexamic acid (TXA) has an effect on the placenta, or if there is considerable transfer of the drug from maternal to fetal circulation. We propose studying the transfer of the drug on a single placental lobule of 7 placentas. We hypothesize that given the large molecular composition of tranexamic acid there will be minimal transfer of the drug in the ex-vivo placental perfusion model, thus providing safety data on the administration of tranexamic acid for therapeutic indications especially during pregnancy. The specific aims are: 1) To set up and troubleshoot the placental perfusion model using 3-5 placental lobules 2) To measure and compare the levels of therapeutic tranexamic acid in the maternal versus fetal perfusate collected from an ex-vivo placental perfusion model.

IRB No. 24-066-2 (Dr. Iman Al-Naggar, PI): Mito-LUTS: A Pilot Study of the Effect of MitoQ on Lower Urinary Tract Symptoms in Older Women with Metabolic Syndrome

Objectives: The goal of this pilot study is to serve as proof-of-concept that using MitoQ, a supplement with gerotherapeutics properties, to target shared biological pathways between aging, metabolic syndrome and lower urinary tract symptoms (LUTS) represents a much-needed novel direction in alleviating lower urinary tract symptoms. It will also help identify and validate biomarkers described in the literature for LUTS diagnosis and severity and generate data required to design and power future clinical trials. Aims: Aim 1: Elucidate the effect of MitoQ on lower urinary tract symptoms (LUTS) in older women with MetS. We will carry out a double-blinded, placebo controlled randomized pilot and exploratory study to test the effect of MitoQ on LUTS in older women with MetS. Older women (50-75 years) with both LUTS (no UTI, with urgency possibly accompanied by other symptoms such as frequency, urgency or urge incontinence for at least 3 months), and MetS (International Diabetes Federation (IDF) definition) will be randomized 2:1 into a treatment (40mg/day MitoQ, for 16 weeks) and placebo arm (Total number of participants will be 50). Assessments of LUTS using well-validated questionnaires and 3-day voiding diaries will be done at baseline, during, and at the end of the drug administration period. Main outcome will be change in LUTS questionnaire scores from baseline for each individual and between Placebo and MitoQ groups. We hypothesize that treatment with MitoQ will improve LUTS questionnaire scores in females with MetS, whereas the placebo group scores will remain unchanged or worsen Aim 2: Measure the effect of MitoQ on biomarkers and their biomarkers and their correlation with LUTS severity. There are currently no clinically useful biomarkers that are specific for LUTS, and novel biomarkers that can reliably distinguish LUTS are urgently needed. A good biomarker would also help with choice of therapy, predict response, change with an intervention and reflect changes in symptom severity. Aim 2a: Does treatment with MitoQ in females with MetS-related LUTS alter blood and urinary biomarkers of biological hallmarks of aging and LUTS? We will measure biomarkers of inflammation and oxidative stress in blood and urine at baseline and 16 weeks after treatment initiation in our participants. We will also measure urinary proteins and metabolites shown to correlate with overactive bladder syndrome (OAB) and others reported to be urotoxic or uroprotective. Values will be compared to baseline for each subject and means will be compared between groups. We hypothesize that MitoQ will reduce biomarkers of inflammation, oxidative stress, and OAB, while also decreasing urotoxic metabolites and increasing uroprotective metabolites. Aim 2b: Do changes in biomarkers correlate with types of LUTS and their severity? In order to be clinically useful, a biomarker should correlate well with LUTS type and severity. Biomarker levels will be correlated to LUTS questionnaire scores and voiding diary parameters. Because LUTS can have multifactorial etiology, no single biomarker has been useful. We aim to identify a panel of biomarkers for diagnosis, prognosis, tailoring, and tracking interventions. We hypothesize that changes in biomarkers will reflect changes in LUTS and correlate with LUTS severity. Study Design: This will be a randomized, placebo-controlled, double-blinded pilot and exploratory study. Participants in the MitoQ intervention group will receive MitoQ capsules (40 mg/day), whereas placebo control group will receive capsules containing all inactive ingredients prepared by the same manufacturer without the MitoQ, for 16 weeks.