Diabetic Neuropathy

Researchers are evaluating an AI-assisted digital health tool called the Smart family doctor to improve control of hypertension, diabetes, and dyslipidemia in adults who have undergone coronary artery bypass grafting CABG or percutaneous coronary intervention PCI. This study uses a randomized controlled design involving about 536 participants across 5-10 hospitals. Participants must be adults aged 18 or older with a history of CABG or PCI and the specified conditions. Participants in the experimental group will use the AI-assisted Smart family doctor app that provides personalized health education, targeted guidance on managing blood pressure, blood sugar, medication adherence, exercise, and smoking cessation. They will also receive tailored reminders and can report self-measured health data for feedback. Both groups receive weekly 3-hour health management guidance from health managers, and participants will wear a smart band daily for health data collection during the 6-month study period. Throughout the study, participants will be assessed for control rates of hypertension, diabetes, and hyperlipidemia at 6 months. Additional measures include blood pressure, cholesterol levels, blood glucose, physical activity, quality of life, psychological status, and cognitive function. The study monitors health data continuously via smart bands and collects self-reports and clinical assessments to evaluate the interventions impact over the 6 months.

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 investigating the relationship between amylin, a hormone increased in people with Type-2 diabetes, and peripheral neuropathy symptoms in patients with this condition. The study explores whether the amount of amylin in the upper limbs correlates with the severity of nerve damage symptoms. This observational study aims to better understand how diabetes-related vascular damage affects nerve function and may identify biomarkers for disease severity. Participants will provide blood samples and skin biopsies from the forearm to measure amylin deposition in blood vessels and red blood cells. The study also includes nerve conduction velocity tests and sensory assessments of pain and temperature response in the upper extremities. These tests occur at the time of sample collection and follow-up sensory testing one week later. Throughout the study, participants undergo clinical sensory exams, nerve conduction velocity testing, and pain threshold evaluations using pressure, cold, and heat stimuli. Researchers will compare amylin levels to symptom severity and nerve function. The study collects data at single time points and includes follow-up sensory testing to provide preliminary insights for larger trials. Total participation involves initial testing and follow-up assessments one week later.

Researchers are evaluating the safety and efficacy of the study drug LY4065967 for treating diabetic peripheral neuropathic pain DPNP. This trial is part of a larger chronic pain master protocol designed to accelerate the development of new treatments for chronic pain conditions. The study focuses on adults with DPNP related to type 1 or type 2 diabetes. Participants will be randomly assigned to receive either LY4065967 or a placebo, both taken orally. The study is double-blinded, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts eight weeks, during which participants take the assigned study drug daily. Throughout the trial, participants will report their pain intensity and other symptoms at the start and after eight weeks using various scales, including the Numeric Rating Scale and Brief Pain Inventory. Researchers will also monitor sleep quality, emotional functioning, and the use of rescue medication. Safety and tolerability will be assessed, and the study concludes in July 2027.

Researchers are evaluating the progress of chronic wounds, specifically venous leg ulcers VLU and diabetic foot ulcers DFU, using an absorbent dressing called Mepilex Up. This study is a prospective, open, multi-center, interventional trial designed to observe wound healing over a period of up to six weeks. The goal is to track changes in wound area and condition while participants receive treatment according to local standards of care. Participants will use the Mepilex Up dressing, which is a soft, silicone-based absorbent foam dressing designed to manage wound exudate and protect the skin. The dressing will be applied as the primary dressing and changed weekly for up to six weeks or until the wound heals. The study includes seven visits a baseline visit followed by weekly visits to monitor wound healing and dressing performance. During each visit, researchers will assess wound progress through measurements and evaluations of wound area, volume, tissue quality, exudate, and skin condition. Participants will report on pain, comfort, and quality of life related to wound care. Safety will be monitored at all visits. The total treatment period is a maximum of 44 days or until healing occurs, with detailed tracking of dressing wear time, wound changes, and any adverse events.

Researchers are conducting a Phase I clinical trial to compare the bioavailability and safety of different forms of SHR-3167 injection in healthy adults between 18 and 55 years old. This study aims to understand how the drug is absorbed and processed in the body, focusing on the maximum plasma concentration and overall exposure to the drug over time. Participants will receive one of three different specifications of SHR-3167 injection in a randomized, parallel, and open-label design. The study will monitor the drugs levels in the blood from Day 1 through Day 71, including measurements such as maximum concentration, area under the curve, time to reach maximum concentration, and half-life. Safety will be assessed by tracking any adverse events and immune responses during this period. During the study, participants will undergo physical exams, vital signs checks, ECGs, chest X-rays, and laboratory tests to ensure health status. Blood samples will be collected multiple times to analyze drug levels and antibodies. The study lasts about 71 days, with continuous monitoring for safety and drug behavior. Participants must comply with study procedures and provide informed consent before joining.

Researchers are evaluating the efficacy and safety of enicepatide, a dual GLP-1GIP receptor agonist, at multiple doses compared with placebo for weight management in adults with obesity or overweight and type 2 diabetes mellitus T2DM. This Phase III study aims to better understand how enicepatide affects body weight and other health measures in this population. Participants will be randomly assigned to receive either placebo or one of three dosing regimens of enicepatide, administered once weekly using an integrated drug-device combination product. The study lasts for 72 weeks, during which participants will self-administer the study drug or receive injections from a trained individual if needed. Throughout the study, participants will undergo various assessments including body weight, hemoglobin A1c, waist circumference, fasting glucose and insulin, cholesterol levels, blood pressure, and quality of life questionnaires. Safety will be monitored through adverse event reporting and specific rating scales. This comprehensive evaluation will help determine the effects of enicepatide on weight and diabetes management over the study period.

The GENESIS clinical study aims to map HLA genetic variation in the Greek population and evaluate possible correlations with selected underlying diseases. It is a multicenter, prospective, non-interventional clinical study targeting 12,000 subjects over an anticipated duration of 36 months, with the goal of creating a pilot HLA map for medical research and possible clinical applications. Each subject will complete one visit at a participating site and provide demographic information, including date of birth, gender, race, ancestry, height, and weight, as well as information about smoking or vaping, alcohol consumption, arterial blood pressure, diagnosed diseases, and current treatments. Recent clinical laboratory results from up to 12 months before sample collection may also be collected when available, including blood count, metabolic, liver enzyme, and biochemical parameters. Two buccal swabs will be collected from each subject for DNA extraction and HLA genotyping analysis. Selected DNA samples will also undergo low-pass whole genome sequencing to further investigate associations between the HLA region and autoimmune diseases. After the analysis is completed, an individualized ancestry report will be securely available to study subjects if they elect to access it.

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.