A Healthier Future—One Clinical Trial at a Time: An Interview With Christine Burt Solorzano, MD

Developing cutting-edge new medical treatments that impact our patients’ lives is a driving force behind research at the School of Medicine. We are committed to pioneering next-generation therapies by translating scientific breakthroughs from our labs into new therapeutics and cures.

Clinical research underpins our ability to advance science and medicine to benefit our patients. Clinical research involves conducting clinical trials where participants join research studies designed to answer specific questions about whether new treatments or drugs are safe and effective. In some cases, these trials may give patients access to novel and exciting therapies that are not available in routine clinical care. Trials may also include physiology studies, procedure studies, public health studies, or mechanism of disease studies. Clinical trials are a long, careful process that may take years to complete.

There are many exciting clinical trials happening right now at UVA. We are thrilled to share more about this important clinical research in Medicine in Motion through a new series called  “A Healthier Future—One Trial at a Time.”

For the series, we interviewed some extraordinary School of Medicine clinical researchers who are conducting innovative and groundbreaking clinical trials. Each researcher discusses a particular study they are conducting — sharing what they hope to learn, potential novel treatment opportunities, how they achieve a diverse subject population, and more.

Kicking off the new series is our interview with Christine Burt Solorzano, MD, a professor in the Department of Pediatrics Division of Endocrinology. Dr. Burt Solorzano is a clinical investigator studying early etiologies of polycystic ovary syndrome in girls and is involved in multi-center studies for type 1 and 2 diabetes in children. She is the director of the UVA Center for Research in Reproduction and also created the UVA Go Girls! Fitness support group, which uses dance to promote physical activity and healthy living in youth.

Q. What do you hope to learn in your study “Hyperandrogenemia and Altered Day-Night Pulse Patterns?”  Will the results potentially change the standard of care for future patients?

Burt Solorzano: Our clinical research studies investigate the origins of polycystic ovary syndrome (PCOS), a condition of male hormone excess affecting ~10% of reproductive-aged women with impacts on metabolic health and fertility.

We’ve learned that excess male hormone production often develops early—during puberty—in girls at risk and that this causes abnormalities in the regulation of gonadotropin signals from the pituitary gland to the ovaries. These signals from the pituitary gland are critical for normal maturation during puberty—when they are disrupted, then PCOS develops in adolescence.

This particular study is looking to see whether the medication spironolactone—which blocks the effects of male hormone—can normalize regulation of gonadotropin signals from the pituitary gland in girls with elevated male hormone levels. This medication is already commonly used in pediatric cardiac care (including for small infants) for blood pressure regulation, so is considered safe for use.

It is also commonly used to treat adolescent PCOS to help decrease symptoms of acne and facial hair. If we can learn how to use the medication effectively to prevent gonadotropin abnormalities during the early pathogenesis of PCOS, we may be able to prevent the disorder’s full-blown manifestations.

Additionally, this study will provide more detailed information about the mechanisms by which early male hormone excess disrupts puberty in girls.

Q. Does your trial give novel treatment or other opportunities to your/our patients?

Burt Solorzano: We use the UVA Exercise Physiology Core Lab to provide subjects with detailed body composition assessment using a BodPod® machine. We obtain a wrist radiograph for bone age to inform about the body’s maturity level. We have the subjects stay overnight at the UVA Clinical Research Unit in Collins for frequent blood sampling (through an IV), to allow us to look at gonadotropin (specifically, luteinizing hormone [LH]) pulses made while the subjects are sleeping. These LH pulse patterns are the signature of progressive reproductive maturity during puberty and also tell us whether PCOS may be developing. This level of detailed information is not available to patients in clinic, but provides research participants with useful data to bring back to their clinicians for discussion about their future risk of PCOS.

Q. What is novel about your study design, treatment, or intervention?

Burt Solorzano: We are one of only a few research institutions globally who are doing this type of detailed puberty hormone assessment in adolescents, which provides very unique information about how PCOS is developing in girls at risk.

Q. How do you ensure inclusion of a diverse subject population?

Burt Solorzano: We welcome study participants from our diverse patient populations in the UVA Health Children’s Hospital clinics, as well as from the general public in the Charlottesville area and the surrounding regions in Virginia.

Filed Under: Clinical, Featured, Research