Hormone Imbalance

Perimenopause is the phase before menopause where women experience symptoms like hot flushes, night sweats, mood swings, anxiety, sleep problems, fatigue, and trouble with memory or concentration. These symptoms can be frequent and intense, affecting quality of life. Despite growing awareness, there is limited research on how diet and supplements impact menopause symptoms. This study investigates the effects of 12 weeks of magnesium supplementation on symptoms, cognition, sleep, and psychological well-being in perimenopausal women. The study compares two groups: one taking a magnesium hydroxide supplement and the other a placebo, both for 12 weeks. Each participant will take two capsules daily of either magnesium hydroxide or placebo. The trial is randomized and triple-blinded to fairly assess the effects of magnesium. The treatment period lasts 84 days with assessments conducted at baseline, 6 weeks, and 12 weeks. Participants will complete memory and cognitive tasks, such as numeric and alphabetic working memory tests, recognition tasks, and the Corsi blocks task, at three time points. They will also fill out questionnaires measuring menopause-specific quality of life, depression, anxiety, stress, mood, and sleep quality. These measures will help researchers understand how magnesium may influence cognition, psychological health, and sleep during perimenopause. The study is led by Northumbria University and plans to end in August 2026.

Perimenopause is a transition phase before menopause, marked by symptoms such as mood changes, anxiety, sleep problems, hot flushes, night sweats, fatigue, and cognitive challenges. These symptoms can significantly impact women's quality of life. Although awareness of menopause has grown, research on nutritional approaches to manage these symptoms remains limited. This study aims to evaluate the impact of a 12-week multi-vitamin/mineral and herbal supplement on perimenopause symptoms, memory, concentration, sleep, and psychological well-being compared to a placebo. Participants will be randomly assigned to one of two groups: one taking a placebo capsule daily for 84 days, and the other taking a multi-vitamin/mineral supplement daily for the same duration. The supplement includes herbal extracts and vitamins recommended by menopause societies. The study will compare the effects of these supplements on symptoms and cognitive function over the 12-week period. Throughout the study, participants will be assessed at the start, at 6 weeks, and at 12 weeks. Assessments include various memory and cognitive tests such as numeric and alphabetic working memory, 3-back task, word and picture recognition, as well as questionnaires on menopause quality of life, depression, anxiety, stress, mood, and sleep quality. The study monitors changes in these areas to understand the supplement's effects on perimenopausal women aged 40 to 60 years.

Researchers are evaluating the use of XYOSTED as a testosterone replacement therapy in adolescent males aged 12 to under 18 years with primary or secondary hypogonadism, a condition where the body produces little or no testosterone. This Phase 3/4 open-label study aims to assess how well XYOSTED supports the continuation or start of puberty, along with its safety and the testosterone levels it maintains. Participants will receive XYOSTED injections at doses tailored to their weight and targeted pubertal stage. Dose adjustments will be made based on testosterone levels measured at specific intervals after dosing, with evaluations approximately every three months to reach the desired hormone levels. After completing the 52-week initial study period, participants may enter a 24-month extension to further monitor long-term safety and treatment effects. Throughout the study and extension, participants will undergo clinical examinations including pubertal staging, blood tests for testosterone and other labs, bone density scans, body composition assessments, and X-rays to monitor bone age. Researchers will track changes in puberty progression, bone health, body measurements, and hormone levels. Participants will attend regular clinic visits every six months during the extension phase to continue safety and pharmacokinetic evaluations.

Researchers are evaluating the effectiveness of a six-month virtually-delivered dietary education program called PEDALL to prevent overweight and obesity during maintenance chemotherapy in children and adolescents with acute lymphoblastic leukemia (ALL). The study focuses on English and Spanish speaking families and considers key genetic and sociodemographic risk factors that may affect weight gain during treatment. Participants will be randomly assigned to one of two groups: the PEDALL intervention group or the standard of care (SOC) group. The PEDALL group will receive 26 contact hours of specialized nutrition education through weekly one-hour virtual sessions over six months. The SOC group will receive printed educational materials and nutritional care according to their institution's usual practices. During the study, participants and their caregivers will engage in nutrition education and counseling sessions. Researchers will assess weight status, body mass index trajectories, lifestyle behaviors, and the influence of genetic and sociodemographic factors over time. The main goal is to prevent unhealthy weight gain during maintenance chemotherapy and improve long-term health outcomes for childhood ALL survivors. The study will last up to 3.5 years for primary outcomes, with additional follow-up extending to four years.

Researchers are investigating the relationship between obesity and type 2 diabetes, conditions influenced by both genetic and environmental factors. This study aims to better understand how different genetic variations affect gene expression in tissues involved in glucose and lipid metabolism, which may contribute to what is called "diabesity," a combined condition of diabetes and obesity. The study uses advanced genomic techniques and bioinformatics to analyze these factors in both humans and animal models. Participants in this observational study are grouped based on their body mass index (BMI) and diabetes or glucose intolerance status. Groups include individuals with BMI ≥ 35 kg/m2 with diabetes, glucose intolerance, or without diabetes, as well as those with BMI < 27 kg/m2 and BMI between 27 and 35 kg/m2 without diabetes. Samples are collected during abdominal surgeries such as bariatric surgery or cholecystectomy to study gene expression and metabolic pathways. During the study, researchers collect biological samples at baseline and follow participants over several years to assess changes in gene expression and insulin resistance. They also evaluate clinical and biological features before and after bariatric surgery at 1, 2, and 5 years. The primary measurement focuses on gene expression in tissues related to glucose metabolism. This long-term observation helps to understand the genetic and phenotypic factors influencing obesity and diabetes, with participation lasting up to 5 years.

Researchers are studying patients with endogenous Cushing syndrome to understand how often adrenal insufficiency occurs when treated with osilodrostat combined with glucocorticoid replacement. The study also examines new steroid biomarkers to monitor osilodrostat dosing, and assesses treatment durability, safety, and clinical improvement. This observational study aims to provide important insights into managing this condition with a block-and-replace approach. The study has two phases. In Phase 1 (Titration), participants start with a low dose of osilodrostat and add methylprednisolone replacement. Doses are adjusted to reach specific cortisol level goals, with frequent monitoring and communication. Once these goals are met, participants enter Phase 2 (Maintenance), where they continue treatment for 48 weeks with periodic cortisol tests to track treatment effects. Participants will regularly provide blood and saliva samples for cortisol and steroid profiling, and report symptoms related to adrenal insufficiency. Researchers will track clinical measures such as blood pressure, weight, and quality of life over about 48 weeks. The main outcome is the percentage of participants experiencing adrenal insufficiency during Phase 1, along with various secondary health and hormone measures throughout the study.

Researchers are investigating whether tirzepatide can improve ovarian dysfunction in premenopausal women with polycystic ovary syndrome (PCOS) who are overweight or have obesity. This phase IV, multi-center, randomized, double-blind, placebo-controlled trial aims to show that tirzepatide at the maximum tolerated dose is better than placebo for improving menstrual irregularity related to PCOS. The study is conducted at five sites in Germany and focuses on women aged 18 to 45 years with PCOS defined by specific criteria.

Researchers are evaluating the safety, tolerability, and how the body processes Semaglutide Nasal Spray compared to a placebo and a known injection in adults who are overweight or obese. This Phase I clinical trial aims to better understand the effects of the nasal spray formulation of Semaglutide in this population. The study is sponsored by Shanghai World Leader Pharmaceutical Co., Ltd. and focuses on adults aged 18 to 65 years with specific body mass index ranges. Participants will receive either the Semaglutide Nasal Spray, placebo, or a Semaglutide injection (Wegovy®) in different randomized groups. The study involves a single-dose administration and includes several cohorts receiving various combinations of the nasal spray and placebo or the injection. Treatments are given once, and the study monitors the participants for up to 36 days after administration to assess drug levels and effects. During the study, participants will undergo various evaluations including blood tests, vital signs monitoring, physical examinations, electrocardiograms (ECGs), and urine analyses from Day 1 to Day 36. Researchers will measure how much of the drug reaches the blood, how long it stays, and any side effects that occur. Antibody levels against the drug will also be checked up to Day 29. Participants will be closely monitored for any safety concerns throughout the study period.

This research aims to evaluate a culturally relevant micronutrient-dense plant-rich (mNDPR) dietary intervention designed to reduce obesity and related disease risks among Native American employees of Twin Arrows Casino. Native Americans face higher rates of obesity and Type II diabetes compared to non-Hispanic Whites. The study involves a randomized controlled trial to assess improvements in physical health measures, wellness, and healthcare costs over one year. Participants will be randomly assigned to either an experimental group receiving a 12-week mNDPR nutrition program or a wait-list control group. The intervention includes a 2-hour initial group session followed by weekly 1-hour coaching sessions led by trained Native American Masters of Public Health students using Motivational Interviewing. Sessions provide nutrition education, cooking demonstrations, workplace dining tours, and social support. The wait-list control group will maintain usual eating habits during the first 12 weeks before receiving the same intervention. Participants will undergo health and wellness assessments at baseline and after 13 weeks, with additional diet recall at week 26 for the experimental group and follow-up measures for the control group. Healthcare utilization will be reviewed at 52 weeks. Researchers will measure changes in Hemoglobin A1c, fasting glucose, insulin, blood lipids, inflammatory markers, blood pressure, and wellness indicators like anxiety and sleep quality. Adherence to the diet will be monitored weekly, alongside attendance and self-monitoring of diet compliance.

This research aims to find out if men with prostate cancer who experience hot flashes due to their Androgen Deprivation Therapy (ADT) will consistently use a smartwatch to track their health and log these symptoms. The study focuses on comparing data recorded by the smartwatch with daily surveys about the participants' hot flashes to better understand their experiences during ADT treatment. Participants will receive an EmbracePlus smartwatch and be trained on how to log hot flashes by pressing a button on the watch at the start and end of each event. They will be asked to wear the smartwatch continuously, except when charging, for 4 weeks. During this time, they will also receive up to four daily electronic surveys via text message to report the frequency and experience of their hot flashes. Throughout the study, biometric data will be collected via Bluetooth from the smartwatch to a smartphone app and then to a secure cloud server for monitoring. Participants will have periodic check-in calls and complete an end-of-study survey. The main outcomes measured include daily watch wear duration, days with logged hot flashes, and how closely the smartwatch logs match the daily surveys. Overall participation lasts 28 days.