Hypothalamic Disorder

Researchers are evaluating a combined sleep promotion and cognitive training intervention to help improve cognitive function in older survivors of intensive care units (ICU). This study focuses on adults aged 60 and older who are at high risk for delirium and cognitive decline similar to mild Alzheimer's disease after ICU discharge. The study aims to assess whether these interventions can reduce the risk of developing Alzheimer's disease and related dementias by addressing sleep deficiency, inactivity, and circadian rhythm disturbances common in ICU survivors. Participants will be randomly assigned to one of four groups: a combination of nighttime sleep promotion using earplugs and eye masks plus daily 30-minute computerized cognitive training sessions; cognitive training alone; sleep promotion alone; or an active control group receiving educational modules on brain health. The interventions last up to seven days following ICU discharge, with cognitive training sessions scheduled based on individual circadian rhythms measured by a wearable sensor. During the study, participants will be monitored using body temperature sensors to optimize the timing of cognitive training. Researchers will assess cognitive function, including executive function and working memory, at several time points: within seven days after hospital discharge, and at one, six, and twelve months follow-up. The study also examines how sleep and activity may influence cognitive outcomes, with safety and ongoing care monitored throughout the study period, which concludes in May 2027.

Researchers are studying RM-718 to assess its safety, tolerability, and how the body processes it in healthy individuals with obesity and in patients with impairments in the MC4R pathway. This study includes people aged 12 to 65 years and focuses on those with hypothalamic obesity and Prader-Willi Syndrome, conditions related to obesity caused by specific brain or genetic issues. The study has four parts: Part A tests single weekly doses of RM-718 or placebo in healthy obese adults aged 18 to 55; Part B tests multiple weekly doses in a similar group; Part C involves multiple weekly doses in patients aged 12 to 65 with hypothalamic obesity; and Part D gives multiple weekly doses to patients with Prader-Willi Syndrome aged 12 to 65. Doses are administered by weekly injections under the skin, and parts A and B are randomized, placebo-controlled, and double-blind, while parts C and D are open-label dose escalations. Participants will receive various weekly doses of RM-718 or placebo depending on their study part, with monitoring for side effects throughout. Researchers will assess safety by tracking adverse events during and after treatment, as well as measure how the drug behaves in the body over time. They will also monitor changes in body mass index, weight, waist size, and hunger symptoms in patients with hypothalamic obesity and Prader-Willi Syndrome. The study includes safety follow-up calls extending up to 210 days after dosing in some parts, with total participation lasting up to 26 weeks depending on the group.

Researchers are evaluating the effects of traditional Chinese medicine combined with intradermal acupuncture on girls with idiopathic precocious puberty, a condition characterized by early onset of puberty without an identifiable cause. This phase 3 randomized controlled trial aims to determine if combining acupuncture point stimulation with herbal treatment can improve symptoms and prevent the condition from worsening. The study focuses on girls with mild to moderate precocious puberty and explores whether this combined approach offers benefits beyond traditional herbal medicine alone. Participants will be randomly assigned to one of two groups. One group will receive Ziyin-Xiehuo traditional Chinese medicine granules twice daily along with intradermal acupuncture point stimulation targeting specific points, applied three times daily with needles changed every two days, for a duration of six months. The other group will receive only the traditional Chinese medicine granules twice daily for the same six-month period. This design allows comparison between combined therapy and herbal medicine alone. During the study, researchers will monitor participants' breast development changes, particularly the reduction or disappearance of mammary nucleus size at three months. They will also assess bone age changes compared to chronological age over six months. Various evaluations such as ultrasound measurements of uterus and ovary size, Tanner staging, and hormone treatment history will be collected. Safety and efficacy will be carefully observed throughout the six-month treatment period.

Researchers are studying how well setmelanotide works to reduce weight, hunger, and improve quality of life in patients aged 4 years and older with congenital Hypothalamic Obesity (cHO). This phase 3 trial evaluates the safety and effectiveness of setmelanotide compared to placebo in this population. Participants have specific diagnoses related to hypothalamic injury and hormone deficiencies, with elevated body mass index (BMI) or BMI percentiles as criteria. Participants will receive a daily subcutaneous injection of either setmelanotide or a placebo in a randomized 2:1 ratio. The treatment period lasts for 26 weeks on a therapeutic regimen. The study is double-blind and placebo-controlled to objectively assess the effects of setmelanotide on weight and hunger measures. During the trial, participants will complete assessments measuring changes in BMI, hunger scores, weight, and quality of life related to weight impact. Safety will be monitored by tracking adverse events throughout the 26-week period. Additional evaluations include changes in BMI z-scores for pediatric patients and physical functioning scores. The trial is sponsored by Rhythm Pharmaceuticals, Inc. and will follow participants from baseline through the 26-week treatment duration.

Researchers are studying how Antimüllerian Hormone (AMH) levels can predict the risk of future infertility in girls aged 3 to 14 who are undergoing cancer treatment or treatment for benign diseases. The goal is to identify young patients who may have a reduced ovarian reserve after treatment and could benefit from special follow-up or fertility preservation. The study includes children at high, moderate/low, or no risk of ovarian damage from chemotherapy or pelvic irradiation. The study observes AMH and other hormone levels before and after treatment, with no interventions applied. Participants are grouped by their risk level: high risk patients receiving conditioning therapy or pelvic irradiation; moderate/low risk patients treated with chemotherapy regimens for various cancers; and a control group with no risk, consisting of patients with benign diseases or cancers not requiring gonadotoxic treatment. Assessments occur at diagnosis, treatment end, and during follow-up visits scheduled yearly for three years, then every two years until age 18. Participants will have their ovarian reserve evaluated through hormone tests including AMH, FSH, estradiol, testosterone, and LH, alongside menstrual cycle tracking and pubertal development assessed annually using Tanner staging and bone age X-rays. The primary outcome is the AMH marker measured regularly up to 18 years old. Secondary outcomes include premature ovarian failure and ovarian reserve changes. The study also monitors oncological outcomes as per standard care, with a total follow-up duration extending to 18 years old.

This research aims to compare the thickness of the endometrial lining in adolescent and young adult females on estrogen replacement therapy using two types of progesterone treatments: daily oral micronized progesterone and the etonogestrel implant. The study focuses on patients aged 12 to 25 years with specific diagnoses requiring estrogen therapy, addressing gaps in knowledge about endometrial protection and bleeding patterns in this group. Participants will choose between two progesterone therapies: oral micronized progesterone taken daily at 100mg or the etonogestrel implant placed in a clinic. The study will last six months, during which participants will continue their estrogen therapy and start their selected progesterone treatment. Two pelvic ultrasounds will be performed, one at the start and one after six months of progesterone use, to measure changes in endometrial thickness. Throughout the study, participants will complete surveys about bleeding patterns, side effects, satisfaction, and adherence to their progesterone treatment. The study team will track medication use through pill counts or photos for those on oral progesterone. All ultrasound and survey data will be securely stored and analyzed to assess the mean change in endometrial thickness and other patient-reported outcomes over six months.

This research aims to understand the nutritional knowledge and dietary habits of athletic women and how these factors might affect their menstrual health. It focuses on women diagnosed with functional hypothalamic amenorrhea (FHA) and those experiencing other menstrual irregularities like oligomenorrhea or polymenorrhea without organic causes. The study is observational and investigates the connection between nutrition and menstrual function in this specific group. Participants are athletic women aged 16 to 30 who engage in physical activity more than two days a week. The study collects data using validated questionnaires to assess nutritional knowledge, eating habits, and eating behaviors. It compares women with FHA to those with other menstrual dysfunctions to evaluate differences in nutrition and behavior. There are no interventions or treatments; the study observes existing conditions and habits at baseline. Participants will complete questionnaires that evaluate their nutritional knowledge and eating behaviors related to menstrual health. Researchers will analyze the data to understand any correlations between diet and menstrual irregularities. The primary outcome is the assessment of nutritional knowledge in women with FHA, while secondary outcomes include comparisons of eating habits and behaviors across different menstrual dysfunctions. The study is sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia and runs through January 2026.

This research investigates how abnormalities in body fat amount, distribution, and function relate to female gonadal dysfunctions, including hypothalamic amenorrhea and polycystic ovary syndrome (PCOS). The study aims to better understand how fat tissue communicates with the female reproductive system and to identify new biomarkers that could help diagnose and treat these conditions. Participants include women with different types of PCOS, exercise-related amenorrhea, and healthy controls. Women in five groups will be studied, including those with exercise-associated hypothalamic amenorrhea, hyperandrogenic and non-hyperandrogenic PCOS (both lean and with weight excess), women who exercise but have normal ovulation, and healthy women with no regular exercise. Researchers will collect samples and data from fat tissue, muscle, blood, and microbiome to analyze proteins, gene expression, hormones, body composition, cardiovascular health, and inflammatory markers. Participants will undergo detailed physical exams, body composition scans, blood tests, glucose tolerance tests, ultrasound imaging, blood pressure monitoring, biopsies, and microbiome sampling. Researchers will measure adipokine and myokine signals over up to five years and assess their associations with reproductive hormones and cardiovascular risk factors. The study includes comprehensive monitoring of metabolism, inflammation, oxidative stress, and the microbiome to explore their links to reproductive health.

Researchers are conducting an observational, longitudinal study focused on patients with pituitary disorders who are followed at the Unit of Endocrinology of Azienda Ospedaliero-Universitaria of Modena. The study is designed to collect detailed clinical and epidemiological data to better understand this patient population over time. It includes both a retrospective phase and a prospective phase to capture comprehensive patient information. The study has two phases: the first phase involves retrospectively registering all patients with pituitary disorders treated at the center. The second phase prospectively enrolls patients attending the Unit of Endocrinology to gather ongoing data. Patients' personal information, details about their pituitary disease, symptoms, physical exams, imaging results, visual field data, and treatments including surgeries, hormone tests, and therapies will be collected and stored in an anonymized database. Participants will be involved through data collection from their medical records and ongoing clinical visits. Researchers will assess various clinical measures such as radiological imaging, hormone levels, and therapy management. The main outcome is to characterize pituitary patients over a 10-year period, along with studying their management. The study is expected to continue monitoring patients throughout this time frame to gain insights into pituitary disease progression and treatment.

Researchers are comparing the effects of dairy products and plant-based alternatives on blood sugar control and nutrient quality in healthy adolescents aged 14 to 18 and older adults aged 60 to 75. This study aims to understand how these different types of foods influence blood sugar regulation and related hormones in these age groups. Participants are healthy individuals without diabetes, and the study is conducted by the University of Toronto in a Nutrition Intervention Center. Participants will be randomly assigned to consume either dairy or plant-based alternative products during the study. The dairy options include items like 2% cow's milk, dairy yogurt, cottage cheese, and isolated whey protein beverage. The plant-based alternatives include soy beverage, plant-based yogurt, tofu, simulated milk, and isolated soy protein beverage. Each participant will consume only one type of dairy or plant-based product depending on their trial group. During study visits, participants will consume these products along with a pizza meal. Participants will visit the Nutrition Intervention Center three times: one 30-minute screening visit and two study visits of approximately 2.5 hours each, spaced over at least two weeks. Before each study visit, participants will fast overnight for 12 hours and maintain their usual diet and sleep habits while avoiding exercise, alcohol, cannabis, and protein supplements. Blood samples and questionnaires will be collected to measure blood sugar, insulin, hormones, and amino acids over 145 minutes after consuming the test products. The research team will monitor participants' responses to evaluate differences in glycemic response and appetite regulation.