Metabolic Disorder

Researchers are evaluating erectile function changes in male patients who undergo percutaneous coronary intervention PCI for either a heart attack or stable angina. The study aims to understand how myocardial infarction affects erectile function over time and to explore whether erectile dysfunction can predict future cardiac events. This observational study compares erectile function between patients with myocardial infarction and those with stable angina using standardized questionnaires. Participants are grouped into two sets those treated with PCI after a heart attack and those treated due to stable angina. Erectile function is assessed at baseline after recovery from PCI, and at 3 and 6 months post-procedure using the International Index of Erectile Function IIEF questionnaire. Additional assessments include the Beck Depression Inventory and Fear of Cardiac Recurrence and Progression Scale. Researchers also collect clinical data such as cardiac vessel scores, ejection fraction, testosterone levels, body measurements, medication use, and the intervention method. During the study, male participants aged 30 to 75 will complete face-to-face interviews and questionnaires at specified intervals baseline, 3 months, and 6 months after PCI. The study measures changes in erectile function scores over time and examines associations with cardiac health, depression, and anxiety symptoms. Safety and participation are monitored throughout the follow-up period. The total duration of involvement is up to 6 months, with evaluations focusing on erectile function and related health parameters.

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.

Noncommunicable diseases like type 2 diabetes and cardiovascular disease cause more deaths worldwide than any other conditions, with a growing impact especially in low- and middle-income countries. Cardiovascular disease CVD is a leading cause of death globally, and its prevalence is rising despite awareness efforts. Diet and nutrition are important factors influencing these diseases, and this research explores the role of a traditional Chinese medicine nutritional drink in supporting cardiovascular health. The study evaluates the effects of the Perfect Heartio drink, a nutritional supplement made from diluted herbal extracts traditionally used in Chinese medicine. Participants will consume 15 grams of the drink twice daily for 12 weeks while their compliance is monitored. This intervention is being studied to assess its potential in improving heart and blood vessel function by measuring various cardiovascular health indicators. Participants will be assessed at the start and at weeks 4, 8, and 12 for lipid profiles, heart inflammation, heart injury, and heart remodeling. Quality of life and self-perceived health status will also be evaluated over these timepoints. The study includes healthy adults aged 18 and above who agree to follow the intervention plan and attend follow-up visits. Monitoring throughout the study will help researchers understand the drinks impact on cardiovascular health markers over the 12-week period.

Glycogen storage disorders GSD are inherited metabolic diseases affecting glycogen production or breakdown, mainly involving the liver and muscles. These disorders vary in severity from mild to fatal in infancy. This study focuses on hepatic GSD types 0a, I, III, IV, VI, IX, and XI in Indian children. It aims to establish a comprehensive Indian GSD registry to better understand the spectrum of genetic defects, natural progression, and how genetic variations relate to disease symptoms in this population. The study is a multicenter observational effort collecting both retrospective and ongoing prospective data from genetically confirmed pediatric hepatic GSD cases. It involves analyzing clinical presentations, outcomes, and genetic variations across multiple centers in India. Retrospective data collection and analysis are planned between May 2024 and April 2025, with continued data submission from new centers and periodic follow-up every 6 months to 1 year. The registry will help guide individualized treatment decisions, including medical therapy or liver transplantation. Participants are children diagnosed genetically with hepatic GSD. The research team reviews clinical data, genetic testing results, and long-term outcomes such as native liver survival and post-transplant complications. The study measures the association between specific gene variants and clinical disease expression over a 5-year period. This ongoing project aims to improve understanding of GSD in Indian children to support better diagnosis, management, and health policies.

The 100-Year Human Aging Study is a long-term observational research project enrolling adult participants to undergo detailed multi-system health screenings and follow them throughout their lives until death. The study aims to identify which health measurements taken at enrollment and repeatedly over time can predict overall mortality, cause-specific death, serious diseases, and functional disability. It addresses the current lack of validated longevity measures by generating data on how various physiological and cognitive functions relate to aging outcomes. Participants undergo a comprehensive clinical screening that includes tests of cardiorespiratory fitness, strength, mobility, neurocognitive performance, sensory functions, and metabolic health. Structural imaging assessments like DEXA scans, echocardiography, electrocardiography, spirometry, retinal photography, and vascular ultrasound are performed. Laboratory tests and detailed medical, social, and environmental histories are also collected. The study allows participation from single tests up to a full two-visit screening, with repeat testing encouraged to track health changes over time. Throughout the study, participants receive individualized reports with investigational estimates of biological age and predicted mortality risks, which are being evaluated against actual health outcomes. Researchers collect data continuously on mortality, disease occurrence, disability, and health behavior changes. The study involves ongoing follow-up with periodic assessments and aims to preserve all collected data for future analyses, with participant involvement potentially spanning their entire lifespan.

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 institutions 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 kgm2 with diabetes, glucose intolerance, or without diabetes, as well as those with BMI < 27 kgm2 and BMI between 27 and 35 kgm2 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.

Urea cycle disorders UCD are rare diseases in China that can cause high mortality and disability, requiring long-term management due to recurring symptoms. This multi-center, prospective, single-arm study aims to evaluate the safety and effectiveness of Glycerol Phenylbutyrate in Chinese children with UCD. The goal is to provide more treatment options and improve clinical care for these patients in China. The study plans a total observation period of five years for patients on long-term treatment with this medication. The study involves 40 children aged from birth to 18 years diagnosed with various types of UCD, including carbamoyl phosphate synthetase I deficiency and others. Participants will receive Glycerol Phenylbutyrate oral liquid, with dosing based on body surface area and divided into multiple daily doses taken with meals. The study includes scheduled clinic visits at 1 month and 3 months after enrollment, followed by visits every 6 months up to 5 years. During these visits, researchers collect data on adverse events, dosage changes, hyperammonemic crises, and blood ammonia levels. Participants will undergo regular assessments including blood tests for ammonia and biochemistry, growth measurements height, weight, head circumference, and neurocognitive evaluations at specified intervals. The primary outcome is the mean blood ammonia level at 3 months after enrollment. Secondary outcomes include ammonia levels at multiple timepoints, frequency of crises, growth data, dosage adjustments, and various neurodevelopmental scores measured annually. This comprehensive follow-up aims to monitor safety, treatment effects, and overall development throughout the five-year period.

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 the safety and tolerability of single and multiple doses of PL54 injections in adults aged 18 to 55 years with phenylketonuria PKU. This Phase I, open-label, dose-escalation study aims to compare the safety profiles between single and multiple dosing regimens and assess pharmacokinetics, pharmacodynamics, and immunogenicity of the drug. The study consists of two phases Phase Ia involves a single subcutaneous injection of PL54 at increasing doses from 0.01 mgkg to 0.5 mgkg, followed by a 28-day observation period with several clinic visits. Phase Ib includes multiple weekly subcutaneous injections for four weeks at doses from 0.04 mgkg to 0.25 mgkg, with a 35-day follow-up after the last dose and scheduled assessments. Dose escalation depends on safety data and committee review. Participants will attend multiple clinic visits for drug administration and monitoring, including assessments of adverse events and blood phenylalanine levels. Researchers will record the severity and relationship of any side effects and measure changes in blood phenylalanine concentration from baseline. The total participation duration is approximately six weeks for Phase Ia and up to nine weeks for Phase Ib, with safety and laboratory assessments throughout.