Polycystic Ovary Syndrome (PCOS)

Researchers are investigating whether a multifactorial lifestyle intervention involving a Mediterranean diet with reduced calories and increased physical activity can help middle-aged adults (30-50 years) with metabolic syndrome lose weight and maintain that weight loss over time. The study also aims to understand the social and demographic challenges people face in sticking to these healthy habits and to examine the lifestyle patterns of this group. Participants will be randomly assigned to one of two groups. One group will follow general lifestyle recommendations from primary healthcare providers, while the other will receive an intensive program that includes monthly individual and group sessions over 6 months to encourage a Mediterranean diet with 25% fewer calories and physical activity based on WHO guidelines. The goal for the intervention group is to reduce their initial weight by 5-10% within 6 months and maintain this loss after 12 months. Throughout the study, participants will undergo assessments including measurements of weight, waist size, blood sugar, triglycerides, and glycated hemoglobin to monitor changes in their health. Data on demographics, diet, clinical parameters, and laboratory tests will be collected. After the 6-month intervention, a follow-up at 12 months will evaluate how well participants maintain their lifestyle changes. The study emphasizes tracking adherence and identifying factors that help or hinder long-term weight loss maintenance.

Researchers are evaluating the PILI 'Aina project to improve the management of common diet-related cardiometabolic diseases like type 2 diabetes, hypertension, dyslipidemias, and obesity among Native Hawaiian adults. This project aims to reduce risk factors for new diet-related illnesses by promoting traditional Native Hawaiian diets and improving social cohesion. The study focuses on adapting and testing an evidence-based multilevel intervention called PILI 'Aina to optimize its effectiveness and sustainability. The study involves a community-level component called 'Ai Pono, which includes quarterly hands-on cooking demonstrations and cultural lessons held over five years, for a total of 36 events. Each 2-hour event features cooking demonstrations, tastings, and education about the cultural importance of traditional foods like sweet potato, breadfruit, and kalo. These lessons aim to improve family and community eating environments and social cohesion. Attendance is limited to 30 people per event, with priority given to new participants after the first lesson. Participants will be surveyed at each event to assess their reactions, fruit and vegetable intake, confidence in healthy eating, and feelings of community support. Additionally, random samples of households in participating homesteads will be surveyed annually to measure family environment, nutrition environment, social cohesion, diet self-efficacy, food literacy, and social support. These assessments will occur at baseline and yearly for four years, helping researchers evaluate the impact and sustainability of the intervention over time.

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 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.

Researchers are evaluating enicepatide, a drug that acts on two receptors related to blood sugar and weight control, for its effects on weight management in people with obesity or overweight who also have Type 2 diabetes mellitus (T2DM). This Phase III study compares multiple doses of enicepatide to a placebo to assess both effectiveness and safety over a long period. Participants will be randomly assigned to one of four groups: three different dosing regimens of enicepatide or a placebo. Both enicepatide and placebo are given once weekly using an integrated drug-device combination product. The study uses a double-blind design, so neither participants nor researchers know who receives the active drug or placebo. Treatment lasts for 72 weeks, allowing detailed assessment of changes over time. Throughout the study, participants will regularly have their body weight measured to track percentage change from baseline, along with many other health indicators including blood sugar levels, cholesterol, blood pressure, and quality of life surveys. Safety will also be closely monitored through assessments of adverse events and specific health questionnaires. The total participation period extends through 72 weeks of treatment and follow-up to observe long-term effects.

Researchers are evaluating the effects of enicepatide, a dual GLP-1/GIP receptor agonist, for weight management in adults with obesity or overweight who do not have Type 2 diabetes. This Phase III trial aims to assess the safety and effectiveness of multiple doses of enicepatide compared with placebo, focusing on body weight changes and related health outcomes. The study is sponsored by Hoffmann-La Roche and targets participants with specific body mass index criteria and weight-related health conditions. Participants will be randomly assigned to one of four groups: three different dosing regimens of enicepatide or a placebo. Both enicepatide and placebo are given once weekly using an integrated drug-device combination product. The treatment period lasts 72 weeks, during which the participants receive regular doses as per their assigned group. Throughout the study, participants will be monitored for changes in body weight, waist circumference, blood sugar levels, cholesterol, blood pressure, and quality of life measures. Assessments include physical exams, questionnaires, and imaging such as MRI to measure body composition. Safety is closely tracked through adverse event reporting and mental health assessments. The total participation duration extends through the 72-week treatment and evaluation period, with detailed follow-up on various health indicators.

This research aims to compare the pharmacokinetics of SJ04, a biosimilar of Ovidrel4, in healthy Chinese female subjects aged 20 to 40 years. The study evaluates how similar the body processes these two recombinant human chorionic gonadotropin injections when given by subcutaneous injection. It is a randomized, open-label, single-dose, two-cycle, double-crossover trial involving healthy women to assess drug similarity and safety. Participants are randomly assigned to two groups: one receives SJ04 first followed by Ovidrel4 after a two-week washout period, and the other receives Ovidrel4 first followed by SJ04 after the same interval. Each injection is a single subcutaneous dose of 250 1g given once per cycle. The crossover design allows each subject to receive both treatments with a washout period in between. During the study, researchers monitor pharmacokinetic measures such as the area under the plasma concentration curve and peak plasma concentration on day 8 after dosing. They also track adverse events and immune responses. The trial involves screening, drug administration on specified days, and follow-up assessments to evaluate safety and drug behavior. Participation lasts through both cycles including the washout and observation periods.

Researchers are studying how the nervous system controls muscle activity in adults aged 60 to 85 who are either highly resistance-trained or untrained. This observational study aims to compare neuromuscular recruitment between these two groups by using advanced neurological techniques to obtain precise measurements. The study includes participants who are generally healthy with a body mass index between 18.5 and 38. Participants will attend five study visits. The first visit includes screening with blood tests, body composition measurement using DEXA, meal tolerance testing, a VO2max cycling test, and muscle strength assessments. The second and third visits involve repeated meal tolerance tests and brain MRI scans. During the fourth and fifth visits, transcranial magnetic stimulation (TMS) combined with electromyography (EMG) will assess muscle excitability and neuromuscular connectivity. Throughout the study, participants will undergo multiple evaluations such as strength testing, blood sampling, imaging, and neurological measurements. The primary outcome is the EMG response after TMS, measured at 21 days. Participants will be monitored for reproducibility of measurements and overall health status. The total involvement spans several visits with detailed assessments to understand neuromuscular function in trained and untrained older adults.