Insulin

This research aims to explore how a dietary supplement called the Insulin Balance Formula may help support healthy insulin levels and its effects on weight, fatigue, and sugar cravings. The study focuses on generally healthy adults who want to maintain healthy insulin levels and improve overall metabolic health using this nutritional approach. It is an observational study where participants act as their own control in a single-arm design to detect initial signals of benefit and gather safety data. Participants will take the Insulin Balance Formula supplement daily for 30 days, starting with one capsule to assess tolerance and increasing to three capsules, ideally one before each meal or all at once. The formula contains five ingredients Berberine, Beta Alanine, Zinc Citrate, Folate, and Fenugreek Extract. During the study, participants will follow a balanced diet and avoid introducing new supplements or health interventions. Throughout the 30-day period, participants will complete several assessments, including body composition measurement, the PROMIS Sleep Disturbance Scale, the Carbohydrate Craving Questionnaire, and evaluations of hunger and fatigue after meals. These will be done at baseline and study completion, with some hunger and fatigue assessments repeated randomly during the study. Participants are encouraged to provide honest feedback, and their privacy is protected. The study aims to generate meaningful data on how this supplement may support metabolic health and guide future research.

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.

Researchers are evaluating a program called LINKED-HEARTS aimed at improving health outcomes for adults with uncontrolled high blood pressure who also have type 2 diabetes or chronic kidney disease. This trial involves 600 adults receiving care at community health centers and compares usual care with an enhanced program that includes home blood pressure monitoring linked to telemonitoring technology and team-based support. The goal is to reduce blood pressure, lower blood sugar levels, and improve kidney function through integrated clinical and community support. The study has two groups one receives enhanced usual care with home blood pressure monitors, and the other participates in the LINKED-HEARTS Program. Participants in the LINKED-HEARTS group will use the Omron 10 series blood pressure monitor with the Sphygmo telemonitoring app. They will also receive education and support from community health workers and telehealth visits with pharmacists who collaborate with providers to optimize medication. The enhanced usual care group also uses the blood pressure monitor with training but receives standard care from their primary doctors. Participants will measure and transmit blood pressure data using the telemonitoring app, and their health will be tracked over 12 months. Researchers will assess blood pressure control, changes in blood pressure readings, blood sugar levels, body mass index, kidney function, and quality of life. The study includes regular monitoring and support to help participants manage their chronic conditions. Total participation lasts at least one year, with outcome measurements at baseline, 12 months, and some quality of life assessments continuing to 24 months.

Researchers are evaluating if the drugs Empagliflozin and Semaglutide, alone or combined, can improve blood sugar control by increasing time-in-range in adults with Type 1 Diabetes who use Automated Insulin Delivery AID systems. This study also monitors the safety of these drugs in this setting. It is a randomized, double-blind, placebo-controlled Phase 3 crossover trial designed to compare the effects of these treatments in the same participants. Participants will receive four different treatment combinations through a crossover design semaglutide injection plus empagliflozin tablet, semaglutide injection plus placebo tablet, placebo injection plus empagliflozin tablet, and placebo injection plus placebo tablet. Semaglutide is given by weekly subcutaneous injection with a 12-week dose escalation period to reach a stable dose. Empagliflozin or its placebo is taken daily by tablet. Washout periods between treatments help avoid carryover effects. During the study, participants will use their personal AID systems continuously while researchers collect continuous glucose monitoring data to measure time-in-range and other blood sugar outcomes. Questionnaires will assess diabetes distress and treatment satisfaction after each intervention period. Safety is closely monitored throughout, including tracking adverse events and providing rescue medications for low blood sugar. The entire participation involves multiple treatment periods with careful monitoring and data collection.

This research aims to find out if the weekly medication tirzepatide can help adults with type 1 diabetes use their insulin pump more easily by reducing or stopping the need to count carbohydrates at meals. People with type 1 diabetes must take insulin for life, but counting carbs is challenging and stressful. Tirzepatide, approved for type 2 diabetes and weight management, may lower appetite, slow digestion, reduce insulin needs, and smooth blood sugar rises after meals in type 1 diabetes as well. The study includes 105 adults with type 1 diabetes, all using the Tandem Control-IQ insulin pump paired with the Dexcom G7 continuous glucose monitor. Participants are randomly assigned to two groups one receives weekly tirzepatide injections with gradually increasing doses for 12 weeks, then stops counting carbs for the last 6 weeks while continuing tirzepatide the other group continues usual therapy, counting carbs throughout. Both groups use the same insulin delivery system and receive training and monitoring. Participants attend clinic visits, complete remote follow-ups, and undergo lab tests, with some also having heart and body composition assessments. Researchers monitor glucose control, insulin use, weight, metabolic markers, meal patterns, and quality of life. The main outcome is whether glucose control without carb counting is as good as with standard care. Safety is closely watched due to possible side effects like nausea and rare risks such as gallbladder disease. The study lasts 32 weeks and aims to see if tirzepatide can simplify diabetes care safely.

Researchers are investigating how metabolism, body composition, and body surface area relate in both healthy individuals and those with metabolic conditions such as diabetes, obesity, renal disease, or cancer. The study aims to improve the accuracy of metabolic rate measurements, which have traditionally relied on simple formulas using height and weight, which may not work well for everyone. Participants will spend two days and one night in the hospital during each visit. They will provide medical history, answer questions about their activity, diet, and lifestyle, and consume a special diet. They will undergo various tests including breathing gas measurements while lying under a clear hood, body scanning on a padded table and with a 3D scanner, electrical signal speed testing through the body, hand strength measurement, and collection of blood and urine after drinking salty water. Participants may return up to eight times per year with at least two weeks between visits. During the study, participants will be evaluated through these tests and questionnaires to understand their resting energy expenditure and body measurements. The primary outcomes include comparing measured versus predicted body surface area and determining how measured body surface area relates to energy expenditure independent of body composition. The study will continue until July 2031, and participants health and ability to complete tests will be monitored throughout their involvement.

Researchers are evaluating QX1206 in an open-label phase 1b trial involving adults with Type 2 Diabetes Mellitus T2DM and Non-Alcoholic Fatty Liver Disease NAFLD. The study aims to determine the recommended dose for future studies and examine the preliminary effects of QX1206 on blood sugar control and other metabolic factors. Participants will take QX1206 orally before bedtime. The trial will last up to 12 weeks, during which laboratory tests and measurements will be taken before the first dose and throughout the study to monitor effects and safety. The study focuses on finding the best dose and assessing changes in blood sugar and insulin resistance. During the study, participants will undergo regular assessments including blood tests for hemoglobin A1c, fasting glucose, insulin levels, and insulin resistance. Researchers will track the recommended phase 2 dose from day 1 through week 12. Patients must comply with study procedures and attend all visits. The total participation period is up to 12 weeks.

Researchers are evaluating the efficacy, safety, and patient-reported outcomes of GZR4 compared to Insulin Icodec in adults with Type 2 Diabetes Mellitus T2DM who are already being treated with basal insulin. This Phase IIIb clinical study aims to better understand how these treatments perform, either alone or with other non-insulin antidiabetic agents, in managing blood sugar levels in this population. The study involves two groups one receiving GZR4 and the other receiving Insulin Icodec. Both treatments are administered subcutaneously once weekly using a treat-to-target dosing approach. Participants will continue their basal insulin treatment during the study period. Participants will be monitored over 26 weeks, with researchers measuring changes in HbA1c levels from baseline to week 26 as the primary outcome. Secondary outcomes include tracking hypoglycemia events, adverse events, and changes in weight. Safety and treatment effects will be assessed through regular visits and evaluations throughout the study period.

This research aims to evaluate whether monitoring insulin levels and treating high insulin and blood sugar levels with the drug pioglitazone is feasible and safe in female patients receiving Alpelisib for metastatic breast cancer. The study focuses on women aged 18 to 85 with ER positive HER2 negative metastatic breast cancer who have a PIK3CA mutation. It also assesses how well this approach controls blood sugar, how often treatment doses are reduced or stopped, and how long patients live without cancer progression. Participants receive treatment with pioglitazone alongside Alpelisib and fulvestrant for their metastatic breast cancer. The study is an early phase 1 trial that follows patients as they receive this combined treatment, focusing on managing hyperinsulinemia and hyperglycemia induced by Alpelisib. The trial tracks treatment safety and feasibility while monitoring patient responses over an average of one year. Throughout the study, patients are regularly monitored for severe and all-grade hyperglycemia, insulin and glucose levels, and treatment side effects. Researchers also measure the progression-free survival of participants. Safety is carefully observed, including any dose adjustments or treatment discontinuations due to blood sugar issues. This monitoring helps evaluate the studys main outcomes and supports patient care during the trial period, which lasts about one year on average.

This research aims to evaluate the safety and effectiveness of a pulsed electric field ablation system in adults aged 18 to 70 with type 2 diabetes mellitus who have suboptimal blood sugar control despite medication or lifestyle changes. The study focuses on patients with glycated hemoglobin levels between 7.5% and 10.5% who have been diagnosed with type 2 diabetes for at least six months. Participants will receive treatment with the pulsed electric field ablation system and be observed over a period of up to 12 months. The study measures changes in HbA1c levels at multiple points after treatment1 month, 3 months, 6 months, and 12 monthsas well as average fasting blood glucose, weight, and the need for additional hypoglycemic medication when HbA1c exceeds 8.5%. Safety is monitored through the recording of adverse events, device performance, and instrument evaluations during the procedure. During the study, participants will attend scheduled visits for assessments including blood tests to track HbA1c and fasting glucose, weight measurements, and monitoring of medication use. The main outcome is the change in HbA1c levels six months after treatment, with additional follow-up up to 12 months to observe ongoing effects and safety. Participants must comply with visit schedules, lifestyle restrictions, and avoid blood donation during the trial.