Dr. Huizhong Tao[/caption]
Huizhong Whit Tao, PhD
Professor of Physiology & Neuroscience
Zilkha Neurogenetic Institute
Department of Physiology & Neurosience
Keck School of Medicine
University of Southern California
MedicalResearch.com: What is the background for this study?
Response: Previously, we published a study in which we found that a group of neurons, namely glutamatergic neurons, in the medial preoptic area (MPOA) of the hypothalamus mediate stress-induced anxiety states. This result inspired us to explore whether the MPOA can play a more general role in mood regulation. Fluctuations in the productive hormones secreted by women’s ovaries are known to cause mood swings.
In some cases, rapid changes in the secretion of ovarian hormones can cause depressive-like symptoms. Key examples are postpartum and peri-menopausal depression. In this study, we intended to test whether the MPOA can also play a part in depressive states that are linked to fluctuations in ovarian hormones.
Dr. Anchan[/caption]
Raymond M. Anchan, MD, Ph.D.
Director, Stem Cell Biology and Regenerative Medicine Research Laboratory
Assistant Professor, Harvard Medical School
Obstetrics/Gynecology
Center for Infertility and Reproductive Surgery
Brigham and Women's Hospital
MedicalResearch.com: What is the background for this study?
Response: As a reproductive endocrinologist, I have the privilege of caring for patients who unfortunately experience premature ovarian insufficiency- Some of these patients are as young as 17 yo. Additionally, a significant number of patients over the years have been reproductive age women who have breast cancer and ovarian failure from chemotherapy. These patients have been my inspiration to try to find a treatment for them. Since my earlier days as a neurobiologist and stem cell scientist, it was a natural course for me to seek cell-based therapies that are patient specific using autologous iPSCs.
Dr. Prior[/caption]
Jerilynn C Prior MD FRCPC (on behalf of all authors
Professor of Endocrinology / Department of Medicine
University of British Columbia
Centre for Menstrual Cycle and Ovulation Research www.cemcor.ca
BC Women’s Health Research Institute
Vancouver BC Canada
MedicalResearch.com: What is the background for this study?
Response: Night sweats and hot flushes/flashes (together called vasomotor symptoms, VMS) disturb women who are still menstruating (in perimenopause) are at least as much or more than menopausal women (without flow for a year or more)1. However, although studies have investigated various treatments for perimenopausal hot flushes/flashes, none have proven effective in these women who are also likely to be having heavy flow, breast tenderness, and premenstrual symptoms related to high and variable estrogen levels. These include randomized controlled trials (RCT) of the birth control pill2, and gel estrogen in women using a progestin-releasing IUD3.
Neither showed that therapy was more effective than placebo; both studied too few participants to provide a clear answer.
Meanwhile, major medical organization guidelines recommend menopausal hormone therapy (MHT, usually of estrogen with a progestin) for any women younger than 60 years old who are bothered by night sweats and hot flushes 4-6. However, there are no scientific RCT studies showing MHT is effective for perimenopausal night sweats and hot flushes. Giving more estrogen to someone whose own estrogen levels are often high, also did not make clinical sense.
We previously performed an RCT showing that oral micronized progesterone (progesterone) was effective for menopausal hot flushes and also improved sleep7. Given that progesterone levels in perimenopausal women are declining, we considered that perimenopausal progesterone therapy for night sweats needed testing.
Dr. Zahedi[/caption]
Dr. Bita Zahedi MD MA
Endocrinologist
Massachusetts General Hospital
MedicalResearch.com: What is the background for this study?
Response: The purpose of this study was to develop and validate a measure of dietary advanced glycation end-products (AGEs) to investigate the role of dietary AGEs in diabetic disease processes. AGEs are a group of highly reactive compounds involved in the pathophysiology of diabetic complications, such as microvascular disease, cardiomyopathy, and possibly bone health. AGEs form through a nonenzymatic reaction between reducing sugars and free amino groups of proteins, lipids, and nucleic acids, also known as a Maillard or browning reaction.
Endogenous AGE formation and accumulation is a normal part of metabolism and aging, however the process of glycation can be enhanced by hyperglycemia, hyperlipidemia, and increased oxidative stress. Additionally, AGEs can be absorbed from exogenous sources via consumption of various food items. Prior studies demonstrate that skin AGEs are predictive of Dietary AGEs (dAGEs) which are naturally present in certain uncooked foods, mainly animal-derived products, furthermore the method of food preparation can result in significant AGE formation. Considering the ubiquitous intake of dAGEs, it is possible that the consumption of exogenous AGEs contribute to AGE-induced oxidative stress, inflammation, and its subsequent detrimental sequalae.
Dr. GALBIATI[/caption]
Francesca Galbiati, MD
Clinical/Research fellow in Endocrinology
Massachusetts General Hospital
MedicalResearch.com: What is the background for this study?
Response: Arginine-vasopressin (AVP) is a neurohormone well known for its role in water balance regulation. It promotes renal water absorption in the kidney, to maintain normal sodium levels in the blood via a tightly controlled osmotic regulation. Besides AVP classical role, data have shown that AVP effects extend beyond water balance regulation. Animal studies have shown that AVP has metabolic effects, including reducing food intake, inducing lipolysis, and promoting muscle regeneration in male mice.
Furthermore, AVP is regulated differently in males and females, and affects cognition differently across sexes, a phenomenon called sexual dimorphism. However, it is unknown whether its dimorphism translates to metabolism. Also, findings on AVP metabolic role are inconsistent, possibly due to the opposing effects of AVP at different receptor subtypes, which regulation is still largely unknown. We performed this study to better investigate AVP metabolic role, and explore sex differences. We hypothesized that AVP would be positively associated with BMI, adiposity, and lean mass (acting as a signal of energy availability). We also predicted that relationships between AVP and body composition measures would differ by sex. We used the AVP area under the curve around a standardized meal to better capture repeated measures in response to food intake (that directly impacts energy availability). This also allowed to avoid the possible risk of fluctuating AVP levels due to possible pulsatile secretion.
Dr. Goodrich[/caption]
Jesse Goodrich PhD
Assistant Professor
Department of Population and Public Health Sciences
Keck School of Medicine
University of Southern California
MedicalResearch.com: What is the background for this study?
Response: Per- and poly-fluoroalkyl substances (PFAS) are a group of persistent chemicals that are known to interfere with hormones and metabolism. In our previous research, we have found that PFAS exposure is associated several specific diseases, especially in children and adolescents. These include obesity, type 2 diabetes, liver disease, and even liver cancer. However, we are still only just starting to fully understand all of the health effects of the many different PFAS in existence. Previous studies have focused primarily on one or two main PFAS. However, there are over 9,000 known PFAS, and people are exposed not just to a single PFAS but to mixtures of many PFAS. Importantly, the combination of these chemical exposures may affect us differently than single exposures alone.
To address this challenge, we used an innovative approach to study design to examine how exposure to PFAS impacts biological processes which may underly the development of many different diseases in adolescents and young adults. To do this, we first measured thousands of naturally occurring chemicals, known as metabolites, in people's blood. Then, using a new biostatistical method developed by our team, we identified how exposure to a mixture of several PFAS impacted each individual chemical. Finally, we used this information to determine which biological processes are changed by PFAS exposure.
Dr. Verma[/caption]
Ashish Verma, MD
Assistant Professor, Nephrology
Department of Medicine
Boston University
MedicalResearch.com: What is the background for this study? Would you tell us a little about aldosterone?
Response: “Recent randomized, controlled trials have shown that a drug called finerenone is effective in delaying CKD progression and adverse cardiovascular outcomes in patients with chronic kidney disease and diabetes. However, the role of aldosterone in this process was not directly investigated and levels of the hormone were not measured,”
“Since excessive levels of aldosterone is common, yet mostly unrecognized, we hypothesized that one reason why finerenone was effective in lowering the risk of CKD progression was that it was treating unrecognized high concentrations of the hormone.”
To study this we investigated the associations between aldosterone concentrations in the blood and kidney disease progression among 3680 participants in the Chronic Renal Insufficiency Cohort study, which ran in seven clinics in the US between 2003 and 2008. The participants were aged between 21 and 74 years old.
Aldosterone is a steroid hormone secreted by the adrenal glands, which sit above the kidneys. Its main role is to regulate salt and water in the body, and so it plays a central role in controlling blood pressure. Too much of it can lead to high blood pressure, cardiovascular and kidney diseases.
Dr. LeBoff[/caption]
Meryl S. LeBoff, MD
Chief, Calcium and Bone SectionDirector of the Skeletal Health and Osteoporosis CenterDirector, Bone Density UnitDistinguished Chair in Skeletal Health and Osteoporosis
Professor of Medicine, Harvard Medical School
Endocrinology, Diabetes and Hypertension, Women's Health
Brigham And Women's Hospital
[caption id="attachment_59356" align="alignleft" width="125"]
Dr. Manson[/caption]
JoAnn E. Manson, MD, DrPH
Professor, Epidemiology, Harvard T.H. Chan School Of Public Health
Michael and Lee Bell Professor of Women's Health, Medicine, Harvard Medical School
Chief, Preventive Medicine, Brigham And Women's Hospital
Co-Director, Womens Health, Brigham And Women's Hospital
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Osteoporosis is a major public health problem. Although supplemental vitamin D has been widely used to reduce the risk of fractures in the general population, studies of the effects of vitamin D on fractures, the most important bone health outcome, have been conflicting.
Randomized controlled trials, the highest quality studies, from around the world have shown benefit, no effect, or even harm of supplemental vitamin D on risk of fractures. Some of the trials used bolus dosing, had small samples sizes or short study duration, and co-administered calcium. No large RCTS of this scale tested whether daily supplemental vitamin D (without co-administration with calcium) prevented fractures in the US population.
To fill these knowledge gaps, we tested the hypothesis in this ancillary study to VITAL, whether daily supplemental vitamin D3 reduced the risk of incident total, non-spine and hip fractures in women and men in the US.
Joe Whittaker, MSc[/caption]
Joe Whittaker, MSc
Nutritionist
MedicalResearch.com: What is the background for this study?
Response: There are several studies showing a generational decline in men's testosterone levels, beginning in the 1970s. This is due to a variety of factors such as poorer diets, lack of physical activity, and increasing toxin exposure. Therefore, there is intense research interest in ways we can optimise testosterone levels, to combat this generational decline.
Some well-known studies have found low-carbohydrate diets boost testosterone levels, but others have show the reverse effect. So, to settle the controversy we gathered and reanalysed all known studies on the topic. There was also the question of high protein diets and their effects on testosterone, which are currently disputed.
Dr. Grant[/caption]
Leilah K. Grant, PhD
Postdoctoral Research Fellow in Medicine
Brigham and Women’s Hospital
Harvard Medical School
MedicalResearch.com: What is the background for this study?
Response: The prevalence of obesity increases in women around the age of menopause which increases the risk of diseases like diabetes and heart disease. Changes in hormones, like estrogen, are thought to contribute to weight gain during menopause, but other common symptoms of menopause such as sleep interruption may also play a role. While short sleep is known to adversely affect metabolism, little is known about the metabolic consequences of the type of sleep disruption most common in menopausal women – increased nighttime awakenings (i.e., sleep interruption) caused by hot flashes, but no change in overall sleep duration. We therefore did this study to see how an experimental model menopause-related sleep interruption would affect metabolic outcomes that may contribute to weight gain.
Dr. Oliver-Williams[/caption]
Dr. Clare Oliver-Williams PhD
University of Cambridge
MedicalResearch.com: What is the background for this study?
Response: Women with PCOS are known to be at greater risk of CVD, however the some symptoms (menstrual irregularity) of PCOS are specific to reproductive age women. This raises the question of whether CVD risk varies across by age, which was the focus of my research with colleagues at the University of Copenhagen.
MedicalResearch.com: What should readers take away from your report?
Response: Women with PCOS were at 19% higher CVD risk than women without CVD, however once the association was stratified by age, there was no evidence for a higher CVD risk for women older than 50.
Elizabeth H.Z. Thompson, Ph.D.
Group vice president, Clinical Development and External Search
Horizon Therapeutics
MedicalResearch.com: What is the background for this study?
Response: This study provides the first U.S.-based validation of the Graves' Ophthalmopathy Quality of Life (GO-QOL) questionnaire. For your background, Graves’ Ophthalmopathy is another term used to describe Thyroid Eye Disease (TED). The GO-QOL questionnaire includes eight questions, each on visual functioning and appearance-related impacts of TED on patients. Though widely used and validated in Europe, the relevance of the questions for patients in the United States hasn’t previously been explored.For this evaluation, 13 eligible TED patients completed the questionnaire and then underwent a separate cognitive QOL-related interview.
Ning Ding[/caption]
Ning Ding MPH, PhD candidate
[caption id="attachment_54465" align="alignleft" width="141"]
Dr. Sung Kyun Park[/caption]
Sung Kyun Park Sc.D, MPH
Associate Professor
Department of Epidemiology
University of Michigan School of Public Health
Ann Arbor, MI 48109
MedicalResearch.com: What is the background for this study?
Response: Per- and polyfluoroalkyl substances (PFAS), also known as ‘forever chemicals’, are a family of synthetic chemicals used in a wide variety of nonstick and waterproof products and firefighting foams. The main issue is that PFAS are everywhere. It has been estimated that 110 million Americans, 1 out of three, may consume drinking water contaminated with PFAS. PFAS are very persistent and once PFAS enter the body, they don't break down and build up in the body over time.
Dr. Donovan[/caption]
Lois Donovan MD FRCPC
Clinical Professor
Cumming School of Medicine
Division on Endocrinology and Metabolism and
Department of Obstetrics and Gynecology
University of Calgary
MedicalResearch.com: What is the background for this study?
1) We observed in our clinical practices that minor TSH elevations in early pregnancy frequently normalized without intervention.
2) Recent randomized control trials have failed to show benefit of treating women with levothyroxine with minor TSH elevations in pregnancy
Dr. Keifer[/caption]
Florian Keifer, M.D., Ph.D
Associate Professor of Medicine
Division of Endocrinology and Metabolism
Department of Medicine III
Medical University of Vienna
MedicalResearch.com: What is the background for this study?
Response: Brown fat, in contrast to white fat, burns significant amounts of chemical energy through heat production. In numerous animal models the activation of brown adipose tissue (BAT) increases energy expenditure and counteracts weight gain. Therefore BAT has been established as a promising target in the fight against obesity and related metabolic disorders. In humans, BAT can be activated by moderate cold exposure, however the function and relevance of BAT are incompletely understood. Using PET scans we identified two groups of individuals those with and without active BAT and studied their differences in energy expenditure and blood fatty acid composition.
Diana Speelman, Ph.D.
Director of Research for the College of Medicine
Associate Professor of Biochemistry
Reproductive System Course Coordinator
L|E|C|O|M
Erie, PA 16509
MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by PCOS?
Response: Polycystic ovary syndrome (PCOS) is the most common hormone disorder in women of reproductive age. It is characterized by high androgen levels (e.g., testosterone) in the blood and irregular menstrual cycles. Despite affecting 5-15% of women, its cause is unknown. While medications can be used to reduce androgen levels, or help achieve menstrual regularity or stimulate ovulation, these often have undesirable side effects. Our goal was to investigate the effectiveness of non-pharmacologic approaches, including yoga, on improving the characteristics associated with the disorder.
Dr. Douglas[/caption]
Dr. Raymond Douglas MD PhD
Board Certified Oculoplastic Surgeon
Beverly Hills, CA
MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by proptosis? How does teprotumumab work?
Response: This study provides pooled efficacy data from the Phase 2 and 3 clinical trials of teprotumumab showing that the recently FDA-approved medicine effectively reduces proptosis, also known as eye bulging, in patients with Thyroid Eye Disease (TED) regardless of age, gender and smoking status. Proptosis is one of the most debilitating symptoms of TED, especially given the accompanying pain, vision impairment and emotional distress.
Teprotumumab is a fully human monoclonal antibody and a targeted inhibitor of the IGF-1 receptor. In patients with Thyroid Eye Disease, the IGF-1 receptor is overexpressed on orbital tissues and when activated, causes inflammation and enlargement of ocular muscles, expansion of orbital tissue and fat and forward displacement of the eye, resulting in eye bulging. The proteins in teprotumumab target and bind to the IGF-1 receptor and inhibit its function, thereby reducing inflammation, preventing tissue expansion behind the eye, and preventing muscle and fat tissue remodeling. Based on this mechanism of action, it is believed that teprotumumab addresses the underlying biology of the disease.
DR. LAWRENCE C. LAYMAN
Dr. Dudley[/caption]
Robert E. Dudley, Ph.D.
Chairman, Chief Executive Officer and President
Clarus Therapeutics
Dr. Dudley discusses the recent announcement that Clarus Therapeutics, Inc. has launched JATENZO® (testosterone undecanoate) capsules for the treatment of appropriate men with testosterone deficiency (hypogonadism):
MedicalResearch.com: What is the background for this announcement?
Response: JATENZO® is the first and only oral softgel testosterone undecanoate and the first oral testosterone product approved by the U.S. FDA in more than 60 years. JATENZO is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
The launch of JATENZO means that physicians and men living with testosterone deficiency due to genetic or structural abnormalities finally have a safe and effective oral testosterone replacement therapy. We are proud to commercially launch this unique oral formulation to healthcare providers and the appropriate patients who they treat. JATENZO is now available at pharmacies across the country.
Dr. Douglas[/caption]
Raymond S Douglas MD PhD
Professor of Surgery, Division of Ophthalmology
Director of the Orbital and Thyroid Eye Disease Program
Cedars Sinai Medical Center
MedicalResearch.com: What is the background for this study?
Response: Thyroid eye disease (TED) is a debilitating disease that affects all aspects of a patients life. It is often associated with Graves' disease and thyroid abnormalities. TED causes profound bulging of the eyes impairing vision, causing eye pain and facial disfigurement.
The most obvious take away is that correcting the magnesium levels can help patients to normalize calcium levels due to the synergy between the two....
Dr. Chiung-Hui Peng[/caption]
Carol Chiung-Hui Peng, MD
Department of Internal Medicine
University of Maryland Medical Center
Baltimore, MD
MedicalResearch.com: What is the background for this study?
Response: In recently published meta-analyses, focusing on the general population, showed that both overt hypothyroidism and subclinical hypothyroidism were linked to higher all-cause and cardiovascular mortality. However, there is still debate and conflicting evidence on managing overt and subclinical hypothyroidism in the elderly.
This study aimed to evaluate and confirm the association between hypothyroidism and mortality in the elderly population.
Dr. Douglas[/caption]
Raymond S. Douglas, MD, PhD
Ophthalmology
Cedars-Sinai, Los Angeles
MedicalResearch.com: What is the background for this study?
Response: The data presented at the American College of Rheumatology (ACR) annual meeting on November 11, 2019 are integrated, pooled efficacy data from the Phase 2 and Phase 3 clinical trials of teprotumumab for the treatment of active thyroid eye disease (TED) compared to placebo. The results support prior analyses of significant reductions in inflammation, proptosis (eye bulging) and diplopia (double vision), as well as improvements in quality of life (QoL). This presentation of the pooled analyses builds on the individual positive results of the Phase 2 and Phase 3 clinical studies.
Dr. Maria Del Pilar Brito[/caption]
Maria Brito, MD
Co-Director, Mount Sinai’s Thyroid Center
Assistant Professor, Medicine, Endocrinology, Diabetes and Bone Disease
Icahn School of Medicine at Mount Sinai
MedicalResearch.com: What is the background for this study?
Response: There have been reports of seasonal fluctuations in thyroid function, however there are no standard guidelines for management of such fluctuations and their clinical implications. It is not a well-studied subject and there are insufficient guidelines around its clinical implications.
MedicalResearch.com: What are the main findings?
Response: Our patient had winter elevation of TSH and summer normalisation repeatedly over a course of three years, but remained largely asymptomatic despite the biochemical alterations.
Dr. Birtwhistle[/caption]
Dr. Richard Birtwhistle, Professor
Departments of Family Medicine and Community Health and Epidemiology
Director of the Centre for Studies, Primary Care, Department of Family Medicine
Queen’s University
MedicalResearch.com: What is the background for this study?
Response: Testing for thyroid dysfunction is a commonly done by primary care practitioners. While the Thyroid stimulating hormone (TSH) test is an easy blood test to perform results outside the normal range are often found and will revert to normal over time without treatment in patients without symptoms.
We wanted to see if there was any clinical benefit to patients by screening for thyroid dysfunction.
Dr. Davies[/caption]
Terry Davies, MD
Co-Director, The Thyroid Center at Mount Sinai Union Square
Professor, Medicine, Endocrinology, Diabetes and Bone Disease
Icahn School of Medicine at Mount Sinai
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Many tissues contain stem cells that are responsible for regeneration and repair after injury. The mechanism of thyroid regeneration and the role of thyroid stem cells in this process is poorly understood. This an exploration of how the thyroid gland repairs itself.
Using a mouse model we found that a damaged gland can correct itself within 4 weeks and this involves a rapid increase in stem cells driving the repair.
Dr Sopio Tatulashvili
Avicenne Hospital
Bobigny, France
MedicalResearch.com: What is the background for this study?
Response: Diabetes and pre-diabetes are associated with increased cardiovascular morbidity and mortality. Early screening and the treatment of glucose metabolism disorders could lower the risk of further complications. Furthermore, type 2 diabetes can be prevented. For this purpose, it is of major importance to better identify the risk factors of type 2 diabetes. Hormonal factors are increasingly suspected to play a role in the etiology of type 2 diabetes. The aim of this study was to determine the associations between various hormonal factors and the risk of incident type 2 diabetes in the large prospective female E3N (Etude Épidémiologique de Femmes de la Mutuelle Générale de L’Education Nationale) cohort study. Based on a very detailed set of information available in 83,799 women from the large prospective E3N cohort study followed for 22 years, we have been able to clarify the relationships between various hormonal factors and type 2 diabetes risk.
Dr. Kenneth Korach[/caption]
Kenneth S. Korach, Ph.D.
Senior Principal Investigator
Chief, Receptor Biology Section
Reproductive and Developmental
Biology Laboratory
NIEHS/NIH
MedicalResearch.com: What is the background for this study?
Response: Lavender oil is among the most popular essential oils used today. Our society deems essential oils and other homeopathic remedies as safe alternatives for medical treatment, personal hygiene commodities, aromatherapy, and cleaning products; however, there are many natural products that have effects on the human body, similar to potent synthetic drugs.
Dr. Weiser[/caption]
Mark Weiser, M.D.
Associate Director for Treatment Trials
The Stanley Medical Research Institute
Kensington, MD 20895
MedicalResearch.com: What is the background for this study?
Response: Over the years many theories have been proposed explaining schizophrenia, and studies tested compounds based on these theories. Some showed improvement in symptoms, but these positive findings were often not later replicated, and the theory discarded. Over the past 15 years several studies performed in Australia by Dr. Jayshri Kulkarni (Molecular psychiatry. 2015;20(6):695) showed positive effects of estrogen patches on symptoms in women with schizophrenia.