Type 2 Diabetes Mellitus (T2DM)

CEEEC-II is a 12-week, community-based, prospective extension study conducted in 32 community health service stations in Kunshan, China. It will invite older stroke survivors with hypertension and/or type 2 diabetes who participated in the preceding CEEEC Phase I trial (NCT06975501) to provide new informed consent and complete Phase II eligibility and baseline assessments. Participants will remain in the physical enrichment, cognitive enrichment, combined enrichment, or usual-care arm assigned to their community cluster in Phase I; no new randomization will occur in CEEEC-II. The upgraded program includes eight physician-led Vitality Camp sessions and four volunteer-led reinforcement activities. The physical component integrates aerobic, resistance, balance, flexibility, Baduanjin, and nutrition education. The cognitive component integrates health education with age-adapted games delivered through an AI-enabled interactive large screen. The primary objective is to evaluate the marginal effect of the cognitive enrichment factor on intrinsic capacity at 12 weeks.

This observational study will evaluate the cardiovascular effects of sodium-glucose cotransporter-2 inhibitors (SGLT2 inhibitors) and glucagon-like peptide-1 receptor agonists (GLP-1 receptor agonists) in Korean adults with type 2 diabetes. The study consists of two phases. Phase 1 will use de-identified electronic health record data from multiple Korean hospitals organized in a common data model. Cardiovascular outcomes, including myocardial infarction, ischemic stroke, and hospitalization for heart failure, will be compared among patients who started an SGLT2 inhibitor or a GLP-1 receptor agonist. Fractures, metabolic changes, and real-world medication use will also be evaluated. Phase 2 will prospectively enroll approximately 100 adults with type 2 diabetes who are starting an SGLT2 inhibitor as part of routine clinical care at Dongtan Sacred Heart Hospital. Participants will undergo electrocardiography, AI-based ECG analysis, echocardiography, blood and urine tests, and body composition assessment at baseline. Approximately 50 participants with stage B heart failure, defined as structural or functional heart abnormalities without heart failure symptoms, will undergo the same assessments after 6 months. The primary outcome of Phase 2 is the change in echocardiographic global longitudinal strain from baseline to 6 months. The study will also examine whether changes detected by AI-based ECG are associated with changes in echocardiographic measures of cardiac function. The study does not assign medications or alter routine treatment. All treatment decisions are made by the participants' treating physicians.

The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA) being developed for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity, and in participants with T2DM who have obesity or overweight.

This study is designed to test the preliminary efficacy of a three-stage continuous glucose monitor (CGM) integration program for older adults who are taking insulin. This study will learn if a three-stage CGM integration program ("intervention") that includes sessions focused on CGM technology skills, data skills, and lifestyle skills impacts CGM wear-time, glycemic metrics, and participant-reported outcomes, compared to two standard CGM training approaches ("comparators"). Following a screening visit and baseline data collection, participants will be randomized to either the intervention or one of the two comparator arms for 6 weeks. The intervention involves three educational sessions over 4 weeks. The first session will be in-person and subsequent sessions will be virtual. Participants in the intervention may receive 1-2 additional individualized training sessions to review CGM skills. The first comparator (Comparator 1) will receive a one-time clinic-based CGM training. The second comparator (Comparator 2) will be provided with a comprehensive informational pamphlet about CGM. All participants will complete outcomes data collection at 6 weeks. The study will also explore participant experiences through a series of semi-structured interviews with a subset of purposively selected participants and their care partners to identify opportunities for scaling the intervention to a broader population. An extension phase of the study will evaluate long-term CGM use and associated outcomes 3- and 6-months post-intervention. Lastly, we will run an additional small sub-study where consented care partners of participants will attend the intervention or comparator sessions alongside the study participant and provide care partner-specific data.

The purpose of this study is to evaluate the effect of a single dose of ALN-4324 on whole-body insulin sensitivity in participants with T2DM

The goal of this clinical trial is to learn whether adding the NutriSteppe digital dietary intervention to routine medical care improves metabolic health in adults aged 21 to 65 years with type 2 diabetes mellitus, obesity, or overweight with related health conditions. Participants are already receiving or have been prescribed glucagon-like peptide-1 (GLP-1) receptor agonist therapy by their treating physicians outside the study. The main question is: Does the NutriSteppe digital dietary intervention improve glycated hemoglobin (HbA1c), a measure of average blood glucose, after 12 weeks compared with routine medical care alone? The study will also assess changes in fasting blood glucose, body weight, body mass index, waist circumference, cholesterol, triglycerides, blood pressure, diet quality, quality of life, dietary adherence, and safety. Researchers will randomly assign participants to one of two groups. The control group will continue routine medical care and receive general lifestyle advice. The intervention group will continue routine medical care and use the NutriSteppe application for 12 weeks to receive personalized dietary support. Participants in both groups will: * Attend study visits and complete the examinations, laboratory tests, and questionnaires specified in the study protocol. * Photograph everything they eat and drink. * Have their food photographs automatically analyzed using Tagam-AI, a system developed for this study. * Be able to view the results of the food photograph analysis. The photography and automated analysis procedures will be the same in both groups. Only participants in the intervention group will receive personalized dietary recommendations generated from these data through the NutriSteppe application.

This randomized, double-blind, placebo-controlled trial will evaluate whether daily calcium beta-hydroxy-beta-methylbutyrate (calcium-HMB) plus vitamin D3 preserves muscle mass, physical function, and resting metabolism in adults aged 65 to 85 years with type 2 diabetes who are newly starting semaglutide as part of usual clinical care. Participants will receive calcium-HMB plus vitamin D3 or matching placebo for approximately 6 months. The primary outcome is change in appendicular lean mass measured by dual-energy X-ray absorptiometry from baseline to month 6. Secondary assessments include body composition, muscle strength, physical performance, gait, physical activity, resting metabolic rate, metabolic measures, and whole-body quantitative computed tomography. An optional mechanistic substudy of up to 36 participants will include D3-creatine dilution, nonradioactive stable isotope infusions, repeated blood sampling, a standardized meal, breath sampling, and vastus lateralis muscle biopsies at baseline and month 6.

Type 2 Diabetes Mellitus (T2DM) is associated with chronic hyperglycemia and metabolic disturbances that affect not only glucose metabolism but also the central nervous system, autonomic nervous system, and cardiovascular function. Growing evidence suggests that individuals with T2DM are at increased risk of cognitive impairment, autonomic dysfunction, reduced functional capacity, and psychological distress. However, the interactions among metabolic status, brain activity, cardiac autonomic regulation, functional performance, and mental health have not been comprehensively investigated within a single study. This cross-sectional study aims to investigate the relationships between metabolic abnormalities and brain-heart axis function in adults with T2DM. Approximately 50 participants aged 40-65 years with a confirmed diagnosis of T2DM will undergo comprehensive assessments, including resting electroencephalography (EEG), heart rate variability (HRV), functional capacity tests (1-Minute Sit-to-Stand Test and 6-Minute Walk Test), cognitive function using the Montreal Cognitive Assessment (MoCA), physical activity using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), and psychological status using the Depression Anxiety Stress Scale (DASS-21). Clinical and metabolic variables, including HbA1c, fasting blood glucose, lipid profile, and inflammatory markers, will also be collected from medical records. The primary objective is to determine whether metabolic disturbances are associated with alterations in EEG-derived brain activity and HRV-derived autonomic function and whether these changes are related to cognitive performance, functional capacity, physical activity, and psychological well-being. Correlation analyses, path analysis, and structural equation modeling will be used to explore direct and indirect relationships among these variables. The findings are expected to improve understanding of the brain-heart axis in T2DM and provide evidence for multidimensional assessment strategies to support early detection of neurocardiac dysfunction and optimize rehabilitation approaches.

This study will be conducted to examine the effect of bitter orange oil inhalation aromatherapy on sleep quality and fatigue levels in patients with Type 2 Diabetes Mellitus (DM). The study will be conducted in the Endocrinology clinic of a university hospital in Türkiye. The research sample will consist of 100 adult patients. Patients will be randomly divided into two groups: the intervention and control groups. Patients in the intervention group will have three drops of bitter orange oil placed on a small cotton ball each night close to bedtime for three consecutive days. They will then hold the cotton ball 5 cm away from their nose and inhale it for one minute while breathing normally. After three consecutive nights of this procedure, sleep quality and fatigue levels will be measured on the morning of the fourth day. Patients in the control group will undergo the same procedure, but instead of orange oil, they will inhale water into the cotton ball.

Only 2% of Americans meet the recommended levels of whole grain consumption, despite its association with reduced risk of type 2 diabetes. This study aims to assess if consumers with prediabetes or type 2 diabetes can be encouraged to switch from buying refined grain products to whole grain products when shopping for groceries online. The study will use personalized marketing strategies, with or without discounts which adjust based on purchasing behavior, to promote whole grain consumption.

The investigators are hoping to determine whether tailoring the diet of someone with type 2 diabetes to their ethnic group while following American Diabetes Association guidelines can make a significant difference in their blood sugar controls. Participants will be required to wear a Continuous Glucose Monitor (CGM) for 1-month so that the investigators can compare blood sugar levels when participants are eating their routine diet vs. the culturally tailored diabetes diet.

The objectives of this study are to better understand how FI (food insecurities) contributes to the development of cardiometabolic comorbidities among PWH (People with HIV) and to test a novel bilingual FI intervention designed to reduce these comorbidities among food insecure PWH. The PI and staff will conduct this study in partnership with the Wake Forest Infectious Diseases Specialty Clinic, one of the largest Ryan White-funded clinics in North Carolina, which serves more than 2,000 PWH annually from a predominantly rural catchment area that includes South Central Appalachia. This area has high rates of both FI and HIV.

This prospective, single-center clinical investigation conducted in France will evaluate two non-invasive investigational devices (HEMI and SPG-NINOX) designed to assess microcirculation in adults. The study will include 165 participants divided into five groups (33 per group): healthy volunteers, patients with hypertension without chronic kidney disease (CKD), patients with type 2 diabetes without CKD, patients with moderate CKD, and patients with severe CKD. The primary objective is to compare baseline small vessel pressure measured with the HEMI (Multi-spectral optical system for microcirculation hemodynamics) device across groups in order to identify microvascular alterations associated with cardiometabolic and renal disease. Secondary objectives include assessment of microvascular responses after post-ischemic hyperemia, evaluation of SPG-derived (Speckle plethysmography) small vessel flow and volume parameters, comparison with reference vascular measurements (including SphygmoCor and ultra-high frequency ultrasound), and evaluation of feasibility, acceptability, and measurement reproducibility. Participation is non-randomized, based on participants' pre-existing clinical condition, and study procedures are non-invasive with an expected visit duration of approximately 60 minutes.

This prospective observational study aims to evaluate serum Neuregulin-4 (NRG4) concentrations in obese and non-obese adults with Type 2 Diabetes Mellitus (T2DM) and to investigate their association with obesity status, insulin resistance, and different antidiabetic treatment regimens. Participants will be categorized into five predefined groups according to obesity status and treatment regimen, including SGLT2 inhibitor users, non-SGLT2 oral antidiabetic therapy users, SGLT2 combination therapy users, newly diagnosed treatment-naïve patients, and healthy controls. Clinical, anthropometric, and laboratory parameters including fasting plasma glucose, HbA1c, estimated glomerular filtration rate (eGFR), body mass index, waist circumference, waist-to-hip ratio, and serum NRG4 concentrations will be evaluated. The study aims to determine whether NRG4 may serve as a novel biomarker reflecting metabolic status and treatment response in patients with T2DM.

This study will evaluate whether a multilingual, feature-phone interactive voice response (IVR) system with human-verified basal insulin titration improves glycemic control compared with standard clinic-based insulin titration among adults with type 2 diabetes and low health literacy in Pakistan. Approximately 220 participants will be randomly assigned to either the IVR-supported titration strategy or usual clinic-based care. Participants will be followed for 12 weeks, with the primary outcome being change in glycated hemoglobin (HbA1c) from baseline to Week 12. Secondary outcomes include fasting plasma glucose, insulin dose adjustment, hypoglycemia, treatment adherence, patient satisfaction, health literacy-related outcomes, and implementation measures.

The goal of this clinical trial is to learn if fecal microbiota transplantation (FMT) can improve metabolic control and immune function in adults with both type 2 diabetes and Hashimoto's thyroiditis (an autoimmune thyroid disease). It will also learn about the safety of FMT in these patients. The main questions it aims to answer are: Can FMT lower blood sugar levels (HbA1c, fasting blood glucose, and 2-hour post-meal blood glucose) in participants with type 2 diabetes? Can FMT reduce thyroid autoantibody levels (TPOAb and TgAb) in participants with Hashimoto's thyroiditis? This is a single-arm study, meaning all participants will receive the same FMT treatment. Researchers will compare each participant's results before and after the intervention to see if FMT has an effect. Participants will: Complete baseline tests including blood work and stool sample collection during the 2-week screening period Take 40 oral FMT capsules by mouth over about 1.5 hours under medical supervision at the start of the study Keep taking their usual diabetes and thyroid medications at the same dose throughout the study, unless their doctor says otherwise Return for follow-up visits and tests at 12 weeks and 24 weeks after the FMT treatment

Patients with type 2 diabetes and cardiovascular risk factors are at increased risk of cardiovascular events. Therefore, a multi-center prospective randomized study will be conducted to compare the efficacy and safety of cilostazol and aspirin for the prevention of major adverse cardiac and cerebrovascular events (MACCE) in high-risk patients with type 2 diabetes.

This study is a single-center, randomized, double-blind, placebo- and active-controlled, parallel-group, single-ascending dose (SAD) design. Insulin degludec and insulin icodec injection serves as the active control and is administered in an open-label manner. The study will be conducted across 6 cohorts, comprising 4 dose-escalation cohorts of UBT38006 (1, 3, 6, and 12 nmol/kg) ， 1 active control cohort of insulin degludec (0.4 U/kg \[2.4 nmol/kg\]) and 1 active control cohort of insulin icodec (1.25 U/kg \[7.5 nmol/kg\]). The safety and tolerability (including local tolerability) as well as the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of single subcutaneous doses of UBT38006 injection will be evaluated in healthy adult male participants. In Cohort 1 (1 nmol/kg), participants will be randomized in a 4:1 ratio to receive UBT38006 injection or placebo. In Cohorts 2-4 (3, 6, and 12 nmol/kg), participants will be randomized in an 8:2 ratio to receive the corresponding dose of UBT38006 injection or placebo. Participants in Cohort 5 (insulin degludec active control) will receive 0.4 U/kg (2.4 nmol/kg) insulin degludec injection. Participants in the insulin icodec cohort received a subcutaneous injection of insulin icodec at a dose of 1.25 U/kg(7.5 nmol/kg). Cohorts 1-4 will follow a double-blind design, while Cohort 5 and insulin icodec cohort will be open-label.

This is a multicenter, prospective, randomized controlled investigator-initiated trial (IIT) aimed at evaluating the efficacy and safety of switching to mazdutide therapy in patients with type 2 diabetes mellitus (T2DM) and moderate-to-severe non-alcoholic fatty liver disease (NAFLD) who have achieved glycemic control. Chinese patients with type 2 diabetes mellitus (T2DM) are susceptible to visceral fat accumulation, which increases the risk of cardiometabolic diseases and mortality. Metabolic associated fatty liver disease (MAFLD) is highly prevalent among Chinese T2DM patients, and the coexistence of T2DM and moderate-to-severe fatty liver significantly elevates liver-related and all-cause mortality. The vicious cycle of hepatic lipid deposition and insulin resistance aggravates T2DM progression, while weight loss has been proven to alleviate hepatopancreatic fat accumulation and improve the management of T2DM. GLP-1 receptor agonists (GLP-1RAs) including semaglutide are standard therapies for T2DM with glycemic improvement and weight-loss benefits. However, nearly a quarter of patients show poor response to semaglutide. Long-term semaglutide treatment may cause GLP-1 receptor desensitization, and the agent lacks direct regulatory effects on adipose tissue and hepatic lipid metabolism. Clinically, many patients still have persistent moderate-to-severe fatty liver despite standardized semaglutide therapy, highlighting an unmet clinical need for optimized treatment. Mazdutide is a novel dual GLP-1R/GCGR agonist. GCGR is highly expressed in the liver and adipose tissues. Via GCGR activation, mazdutide directly inhibits hepatic lipogenesis, promotes hepatic fat decomposition and fatty acid oxidation, and improves adipose tissue browning and thermogenesis. Compared with single GLP-1RAs, mazdutide exerts more direct and comprehensive regulatory effects on hepatic and systemic lipid metabolism, making it a promising option for T2DM patients with residual moderate-to-severe fatty liver after semaglutide treatment. This study is a multicenter, prospective, stratified randomized controlled design and enrolls T2DM patients with persistent moderate-to-severe NAFLD after receiving subcutaneous semaglutide 1.0 mg once weekly for ≥28 weeks. with 1:1 group allocation and concealed grouping. Eligible subjects are randomized into two groups without drug washout: the intervention group switches to mazdutide therapy, while the control group continues semaglutide treatment. All baseline concomitant medications for metabolic diseases remain stable throughout the study to avoid confounding factors. Mazdutide is titrated per official instructions, initiating at 2 mg once weekly and escalating to a 4 mg once weekly maintenance dose based on patient tolerability and efficacy. All participants maintain their habitual diet and exercise routines with regular lifestyle supervision to ensure study stability. After the initial intervention phase, patients with \<30% reduction in hepatic fat content will receive a mazdutide dose increase to 6 mg once weekly. Meanwhile, the control group will cross over to mazdutide treatment, and all patients will enter the subsequent observational stage. The primary endpoint is the change in hepatic fat content from baseline to study endpoint, measured by MRI-PDFF and liver elastography, to evaluate the efficacy of mazdutide on hepatic steatosis. Secondary endpoints include inter-group differences in glycemic control, body composition, islet function, liver enzymes and lipid profiles. The efficacy changes during the crossover period are also observed. All adverse events are recorded to assess the safety and tolerability of mazdutide in this patient population.

This retrospective observational target-trial emulation uses electronic health record data from the TriNetX US Collaborative Network to compare preadmission glucose-lowering treatment strategies in adults with type 2 diabetes hospitalized with pneumonia. Time zero is the date of the index pneumonia admission. The study compares patients with evidence of prescriptions for both a GLP-1 receptor agonist and an SGLT2 inhibitor in the year before admission with patients prescribed a GLP-1 receptor agonist alone, an SGLT2 inhibitor alone, or usual care. Usual care includes metformin, sulfonylureas, or DPP-4 inhibitors without either study class. The primary outcome is a composite of all-cause death, invasive mechanical ventilation, or renal replacement therapy within 30 days of admission, with the individual components and 12-month mortality, major adverse cardiovascular events, and major adverse kidney events also evaluated. Propensity-score methods are used to reduce bias from nonrandom treatment selection.

This is a clinical trial to assess how time-restricted eating (TRE) may improve kidney health and filtration patients with type 2 diabetes and increased protein content in their urine. All participants will be participating in TRE in which they follow a consistent 8-10 hour eating window everyday.

This observational cross-sectional study will evaluate salivary apelin, chemerin, ghrelin, and lipocalin-2 levels in individuals with different periodontal and systemic conditions. Participants will be divided into four groups according to periodontal status and the presence or absence of type 2 diabetes mellitus. Clinical periodontal measurements and unstimulated saliva samples will be obtained before periodontal treatment. Salivary biomarker levels will be measured using enzyme-linked immunosorbent assay kits. The study aims to determine whether salivary apelin, chemerin, ghrelin, and lipocalin-2 levels are associated with periodontitis, type 2 diabetes mellitus, and periodontal clinical parameters.

The purpose of this project is to evaluate the effectiveness of diabetes distress screening and intervention on patients with type 2 diabetes mellitus (T2DM).

The goal of this clinical trial is to Evaluate the Safety and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Adult Type 2 Diabetes Mellitus.

This study tests whether an artificial intelligence (AI) tool can help doctors choose better diabetes medicines for their patients. Type 2 diabetes is very common, but there are far more patients than diabetes specialists, so many patients are treated by doctors who are not diabetes specialists. The researchers built an AI consultation system that gives doctors real-time suggestions and predictions about diabetes medicines while they are prescribing. The doctor always makes the final decision. In this trial, patients with type 2 diabetes whose blood sugar is not well controlled will be placed by chance (randomly) into one of two groups. In one group, the doctor uses the AI system when deciding on diabetes medicines. In the other group, the doctor prescribes as usual, without the AI system. All medicines used are already approved in Taiwan and given at approved doses. The study follows each patient for 12 months, with check-ups at the start and at 3, 6, 9, and 12 months. The main goal is to compare how much the patients' long-term blood sugar level (HbA1c) improves between the two groups after one year. The researchers also look at how many patients reach their blood sugar target, how often low blood sugar happens, and whether any side effects occur. The aim is to find out whether using the AI tool leads to better blood sugar control.