Endocrine Disorder

Researchers are investigating whether sexual activity affects the risk of low blood sugar (hypoglycemia) in adults with type 1 or type 2 diabetes who use insulin therapy and continuous glucose monitoring (CGM). Many people with diabetes worry about hypoglycemia during or after sexual activity, which can impact their quality of life and willingness to be intimate. This study addresses the gap in research caused by the sensitive nature of sexual health and the previous lack of tools to remotely monitor glucose levels. Participants will use CGM systems such as LibreView or Dexcom Clarity to track glucose changes during and up to six hours after sexual activity. They will mark the start of sexual activity in their CGM app using a neutral icon like a heart. The study is observational, so participants continue their usual insulin therapy and self-care. Data from days with and without sexual activity will be compared over a three-month period for each participant. During the study, participants will be observed for three months while researchers collect glucose data and sexual activity markers remotely and securely. Healthcare providers will also provide basic clinical information. The primary outcome is the proportion of sexual activity episodes linked to hypoglycemia, defined as glucose levels below 70 mg/dL during or after sexual activity. The study aims to include 100 adults and hopes to provide evidence to guide future care recommendations or reduce fears related to sexual activity and hypoglycemia.

Researchers are evaluating whether taking tirzepatide before bariatric surgery can improve outcomes for adults with obesity and related health conditions. This Phase 4 study focuses on patients scheduled for sleeve gastrectomy or gastric bypass surgery. The goal is to see if preoperative tirzepatide reduces inflammation and improves weight loss, metabolic health, and surgical recovery compared to patients not using the drug. Participants will be assigned to either a group that receives tirzepatide injections once weekly for three months before surgery or a standard care group that receives dietary and lifestyle education. Those taking tirzepatide will start with a 2.5 mg subcutaneous injection once a week and may have their dose increased following package instructions during monthly clinic visits. All participants will continue with their planned bariatric surgery and follow-up care as usual. Throughout the study, participants will visit the endocrine clinic monthly for drug prescriptions and side effect monitoring. They will keep diaries to track drug use and any side effects. Researchers will measure changes in inflammatory markers such as CRP, IL-6, TNF, leptin, adiponectin, and RAAS from baseline to three months after starting the drug, and RNA sequencing will be performed at surgery. The study will also assess weight loss, metabolic and inflammatory improvements, comorbidity resolution, and 30-day postoperative complications.

Researchers are investigating the use of Ga-68-DOTATATE PET/MRI scans in diagnosing and managing patients with somatostatin receptor-positive central nervous system (CNS) tumors, mainly meningiomas, but also including other tumors like esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma, and certain brain metastases from systemic cancers. This study aims to determine if Ga-68-DOTATATE PET/MRI can better distinguish tumor recurrence from post-treatment changes, improving diagnosis and treatment planning. The investigation builds on prior pilot data showing promising results in detecting residual tumor and additional lesions not visible on MRI alone. Participants with meningioma who are planning surgery will have a Ga-68-DOTATATE PET/MRI scan combined with their standard care MRI before surgery for research purposes. Up to two additional follow-up PET/MRI scans may be performed as part of standard care. For patients with other somatostatin receptor-positive CNS tumors, PET scans may be added to their routine MRI to assess disease extent. When necessary, 1.5 Tesla MRI combined with PET/CT fusion imaging may be used instead of 3 Tesla MRI. During the study, participants will undergo these imaging procedures and clinical evaluations over time to assess the usefulness of Ga-68-DOTATATE PET/MRI in their care. Researchers will follow participants longitudinally, up to 10 years, to evaluate whether the scans provide additional clinical benefit in monitoring tumor status. Safety monitoring and diagnostic assessments will be conducted throughout the study to ensure accurate and informative results.

Researchers are studying patients with endogenous Cushing syndrome to understand how often adrenal insufficiency occurs when treated with osilodrostat combined with glucocorticoid replacement therapy. They are also assessing new steroid biomarkers to monitor if osilodrostat dosing is appropriate, along with evaluating the safety, durability, and clinical improvement during treatment. This study follows a block-and-replace approach to manage hormone levels. The study includes two phases. In Phase 1 (titration), participants start with a low dose of osilodrostat and then add methylprednisolone replacement doses. Osilodrostat dosing is increased as needed to reach target cortisol levels, with frequent check-ins and lab tests every 4 to 12 weeks. Once cortisol goals are met, participants move to Phase 2 (maintenance), where they continue their doses and are followed for 48 weeks with periodic hormone tests to monitor treatment effects. Participants provide informed consent and undergo regular monitoring including blood and urine tests to measure cortisol and steroid profiles. Study staff maintain close contact during the titration phase to watch for signs of adrenal insufficiency. Throughout the maintenance phase, participants have hormone levels checked every 3 to 6 months or as needed. The main outcome measured is the percentage of participants experiencing adrenal insufficiency during the titration phase, lasting about 24 weeks.

Researchers are evaluating the safety and tolerability of GenSci134, a drug given by subcutaneous injection, in healthy adult volunteers and patients with adult growth hormone deficiency (AGHD). This Phase I study includes healthy males and females as well as AGHD patients to explore dosage, safety, pharmacokinetics, pharmacodynamics, immunogenicity, and other exploratory endpoints. The goal is to understand how well GenSci134 is tolerated and how it behaves in the body across different groups and doses. The study is divided into two parts: the first involving healthy volunteers and the second involving AGHD patients. The healthy volunteer part has two phases: Phase Ia tests single ascending doses in healthy males across seven dose groups with placebo and active controls; Phase Ib tests multiple ascending doses in males and females across three dose groups with placebo controls. The second part, Phase Ic, tests single ascending doses in AGHD patients across two dose groups with active controls. Treatments include subcutaneous injections of GenSci134, placebo injections, and for AGHD patients, a daily injection of recombinant human growth hormone for 28 days. Participants will undergo safety and tolerability assessments, including monitoring adverse events from the first day up to three months. Researchers will also collect pharmacokinetic and pharmacodynamic data, measure immunogenicity, and perform exploratory evaluations. Participants will attend scheduled visits, complete laboratory tests, and comply with study procedures. The study involves detailed monitoring to evaluate the safety profile and biological effects of GenSci134 in both healthy adults and patients with AGHD.

Researchers are conducting the GENESIS clinical study to map the HLA genomic region in the Greek population and explore possible links to certain diseases. This multicenter, prospective, non-interventional study plans to enroll around 12,000 adults over 36 months. The goal is to create a pilot map of HLA genetic variation to support medical research and potential clinical uses, including evaluating connections with various health conditions such as respiratory, cardiovascular, metabolic, neurological, psychiatric, gastrointestinal, hematologic, rheumatologic diseases, and chronic renal failure. During the study, participants will visit a participating site once to provide demographic information, lifestyle habits, medical history, and recent clinical lab test results if available. Two buccal swabs will be collected from each participant for DNA extraction and HLA genotyping analysis. Selected samples will also undergo full low-pass whole genome sequencing to further study associations between the HLA region and autoimmune diseases. After analysis, participants can securely access a personalized ancestry report if they wish. Participants will be asked about their health, lifestyle, and medical treatments, and provide samples for genetic testing. Researchers will monitor the allele frequency of HLA alleles at the Greek population level over 36 months. The study includes secure data handling and offers long-term follow-up through genetic and ancestry reports. This comprehensive approach aims to enhance understanding of genetic variation and its possible disease correlations in Greece.

Researchers are evaluating the effects of Diaberine, a berberine-based nutraceutical supplement, on blood sugar regulation and metabolism. This randomized, triple-blind, placebo-controlled study involves 80 participants aged 18 to 70 years with a metabolism disorder and aims to assess the supplement's efficacy and tolerance over 24 weeks. Participants will be randomly assigned to take either Diaberine or a placebo capsule. Each participant will take one capsule three times daily, 15 minutes before meals, throughout the 24-week study period. The study compares the effects of the active supplement to the placebo under these controlled conditions. During the study, participants will be monitored at baseline, week 12, and week 24 to evaluate changes in blood sugar regulation and metabolism. Researchers will collect data on these primary outcomes while ensuring participants maintain their usual diet, sleep, and activity levels. Safety and adherence to the study protocol will also be observed throughout the trial.

Researchers are evaluating the effects of semaglutide and empagliflozin, alone and combined, when added to Automated Insulin Delivery (AID) systems in adults living with Type 1 Diabetes. This Phase 3, randomized, placebo-controlled, double-blind, crossover trial aims to see if these medications improve the time blood glucose levels stay within the target range (time-in-range). The study also assesses the safety of these drugs in this treatment context. Participants will experience four different treatment periods involving combinations of weekly semaglutide or placebo injections and daily empagliflozin or placebo tablets. Semaglutide will be titrated over 12 weeks to reach a stable dose. Each intervention period lasts four weeks, with washout periods of two to four weeks between injection arms and one to seven days between tablet administrations. Participants continue to use their personal commercial AID systems throughout. During the study, participants will have continuous glucose monitoring to track blood sugar levels and complete questionnaires on diabetes distress and treatment satisfaction after each intervention. Adverse events will be monitored from consent through study completion. The primary outcome is the time-in-range measured at multiple points during the titration and intervention periods. The total involvement includes screening, titration, four intervention phases, and safety monitoring.

This research aims to evaluate the safety, how the body processes, and the effects of an investigational drug called GNR-055 in patients with Mucopolysaccharidosis Type II (MPS II), also known as Hunter syndrome. MPS II is a genetic condition caused by a deficiency of a specific enzyme, leading to harmful buildup in the body that affects growth, bones, joints, respiratory and cardiovascular systems, and may involve the nervous system causing cognitive and motor impairments. This phase 2/3, multicenter, open-label study includes patients of different age groups to better understand the drug's impact. Participants will receive weekly intravenous infusions of GNR-055 in doses ranging from 1.0 to 3.0 mg/kg. The drug is a modified enzyme designed to reach the brain to potentially prevent neurological damage. The study includes several cohorts receiving different dosages, with treatment ongoing up to 56 weeks. This approach allows researchers to monitor how the drug behaves in the body and how it affects disease markers over time. Participants will be monitored through clinical assessments, including measurements of urine glycosaminoglycan (GAG) levels at multiple points up to week 52 and tracking adverse events throughout the 56-week study period. Safety evaluations, pharmacokinetics, pharmacodynamics, and efficacy will be assessed regularly. The study aims to provide detailed information about the treatment's safety and potential benefits to improve quality of life for patients with MPS II.

Researchers are studying how metabolism relates to body composition and body surface area in a wide range of people, including healthy individuals and those with metabolic conditions like diabetes, obesity, kidney disease, or cancer. The goal is to find more accurate ways to measure metabolism than traditional methods based on height and weight. This natural history study looks at resting energy expenditure and how it relates to body measurements in both healthy and diseased participants aged 2 years and older. Participants will spend 2 days and 1 night in the hospital during each visit. They will provide their medical history and answer questions about their activity, diet, and lifestyle. They will eat a special diet and undergo multiple tests, including lying under a clear hood to measure breath gases, body scans while lying down and standing, tests measuring electrical signals through the body, hand grip strength tests, and giving blood and urine samples. Participants may return for up to 8 visits per year, with at least two weeks between visits. During the study, researchers will measure differences between predicted and measured body surface area and track how these measurements relate to resting energy use. They will monitor participants' health through various assessments and samples collected at each visit. The study aims to improve understanding of metabolic rates and body measurements, with ongoing safety and progress monitored throughout participation.