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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. 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.

IRB No. 24-111JSF-1 (Dr. Danielle Luciano, PI): The CT EndoRISE Biorepository

According to Connecticut Public Act No. 22-33, the CT EndoRISE biorepository will prospectively collect endometriosis tissues (termed lesions), healthy endometrium, blood, urine, and peritoneal fluid samples along with linked clinical and phenotypic data, symptoms, and quality of life questionnaires from patients with endometriosis and healthy controls. The CT EndoRISE is a collaboration between The Jackson Laboratory for Genomic Medicine and UConn Health.

IRB No. 25-223-1 (Dr. Amanda Ulrich, PI): The Impact of vNOTES Hysterectomy on Sexual Function as Compared to Conventional Laparoscopic Hysterectomy and Robotic Assisted Laparoscopic Hysterectomy

This study aims to compare three different modalities of hysterectomy on female sexual function. vNOTES hysterectomy the newest surgical approach, will be compared to conventional minimally invasive and robotic assisted approaches. Pre- and post-operative surveys will be administered to assess female sexual function quantitatively using a validated survey called the female sexual function index. The change in this study from pre- op to 3-month and 6-months post-op will be compared between the 3 surgical approaches to determine if vNOTES hysterectomy has a negative impact on female sexual function.

IRB No. 26-128-1 (Dr. Elizabeth Morgan, PI): An Assessment of Pregnancies Complicated by Macrosomia

The term "macrosomia" is used to describe infants that are at or above a birth weight considered excessive. This threshold birth weight is typically set at more than 4,000 or 5,000 grams. Excessive fetal growth is a concern for both the obstetrician and the patient because as birth weight increases the risk of delivery complications increase for both the infant and mother. Neonatal complications of macrosomia include shoulder dystocia with brachial plexus injury, depressed APGAR scores, hypoglycemia, and admission to the neonatal intensive care unit (7). Complications increase with increasing birth weight. A study of 175,886 vaginal deliveries in California documented an odds ratio for shoulder dystocia of 3.542 for birth weight of 4000-4500 grams and 10.122 for birth weight greater than 4500 grams. Infants weighing greater than 5000 grams were twice as likely to die than those with a normal weight (3000-3999 grams) (2). Maternal complications known to be the result of delivering a macrosomic infant include postpartum hemorrhage, third or fourth degree lacerations, risk of cesarean delivery after protracted labor and arrest disorders, and chorioamnionitis (7). Patients diagnosed with suspected macrosomia by ultrasound have an increased cesarean delivery rate for labor arrest noting that ultrasound estimation or over estimation may lead to a lower threshold to call for cesarean delivery (8). Another study documented that patients that were diagnosed prenatally with macrosomia had 3.5 times the risk of cesarean delivery compared to those that were not diagnosed prior to delivery (9). The risks of postpartum hemorrhage, prolonged labor and cesarean delivery all increased with increasing macromia; 4000-4499, 4500-4999, and >5000 (2). Reported risk factors for having a macrosomic infant include history of macrosomic infant, post-term pregnancy, maternal prepregnancy obesity, excessive gestational weight gain, and preexisting and gestational diabetes (GDM) (3,4). We seek to examine the trends in the delivery of macrosomic infants at UConn Health, Hartford Hospital, St. Francis Hospital and Medical Center, including yearly rate of macrosomic infants delivered and the complications associated with these deliveries. We will also attempt to determine risk factors for excessive infant growth in order to look for interventions that could improve outcomes. Our primary objective is to examine the trends in the delivery of macrosomic infants at UConn Health Center, Hartford Hospital and St. Francis Hospital and Medical Center, and including yearly rate of macrosomic infants delivered and the complications associated with these deliveries. We will also attempt to determine risk factors for excessive infant growth to look for interventions that could improve outcomes. Data collected will include newborn data of infants cared for in the respective postpartum/nursery units, hospital neonatal intensive care units (NICU) and Connecticut Children's Medical Center NICU. We hypothesize that there has been an increase in the rate of macrosomic infant deliveries at UConn Health Center, Hartford Hospital, and St. Francis Hospital and Medical Center since 2018. This could be due to an increase in excessive gestational weight gain and gestational and pre-gestational diabetes.