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Clinical Research Directory

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44 clinical studies listed.

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Diabete Type 2

Tundra lists 44 Diabete Type 2 clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.

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NOT YET RECRUITING

NCT07518121

A Bridging Study of Efsubaglutide Alfa in Healthy Adults in Brazil

This is a Phase I, randomized, double-blind, placebo-controlled, single-dose study in healthy adult participants in Brazil to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of YN-011. Participants will be randomized to receive a single subcutaneous dose of YN-011 1 mg, YN-011 3 mg, or matching placebo. The study includes screening, approximately 2 days of study-site confinement from the day before dosing to 24 hours after dosing, and outpatient follow-up for 4 weeks. Assessments include safety monitoring, PK blood sampling, PD evaluations, and immunogenicity testing.

Gender: All

Ages: 18 Years - 45 Years

Updated: 2026-04-08

1 state

Diabete Type 2
RECRUITING

NCT07506356

Investigation of Gastric Emptying by Gastric Ultrasonography in Diabetic Patients Treated With GLP-1 Receptors

Treatment with semaglutide slows down gastric emptying , food remains in the stomach for a longer period of time. This slowing has important implications for anesthesia management. At present, we do not know the optimal duration for discontinuing this medication before surgery and anesthesia to ensure an empty stomach. This is an observational research project, conducted exclusively at the Geneva University Hospitals (HUG). To answer the research question, participation of 38 individuals will be required. The duration of participation for each person is 7 days. To recruit the necessary number of participants, approximately 1.5 years will be needed. This project is being carried out in accordance with Swiss legal requirements and recognized international guidelines. The competent ethics committee has reviewed and approved this project. The project will last 7 day during which the participants will need to come 3 times at the hospital to make gastric ultrasounds. On these days the participants will be asked to have a breakfast between 7 and 8 am including a minimum of bread and/or cereals and/or proteins. After that the participants will be asked to fast for 6 hours for solide food and 2 hours for liquids. If the participants smokes, they must for 12h before the exam. At 2Pm an anesthesiologist will welcome the participant to make the exam at the hospital to evaluate the gastric volume after what the participants will be able to get a small collation and go back home.

Gender: All

Ages: 18 Years - Any

Updated: 2026-04-01

1 state

Diabete Type 2
Regurgitation
Pulmonary Aspiration During Anaesthetic Induction
ACTIVE NOT RECRUITING

NCT07502755

Non-invasive Tests for Non-alcoholic Steato-hepatitis

The main objective is to study and validate a new approach for NASH and liver fibrosis diagnosis and personalized follow-up based on monocyte biomarkers and plasma metabolites. The investigators will assess if PLIN2 and RAB14 can be used not only to identify subjects with NASH and advanced fibrosis but also for monitoring the effect of treatment alone or in combination with other metabolic parameters

Gender: All

Ages: 25 Years - 65 Years

Updated: 2026-03-31

NASH With Fibrosis
Diabete Type 2
Obesity
RECRUITING

NCT07495787

Magnetic Compression Anastomosis Procedure for Partial Jejunoileal Anastomosis: Assessing the Viability of an Innovative Metabolic Approach

English, Hindi and Gujarati

Gender: All

Ages: 25 Years - 65 Years

Updated: 2026-03-27

1 state

Diabete Type 2
NOT YET RECRUITING

NCT07471802

Monitoring of the Sympathetic/Vagal Balance Through Multiparametric Analysis of Heart Rate Variability (HRV)

The autonomic nervous system (ANS) plays a crucial role in cardiovascular regulation by modulating heart rate in response to endogenous and environmental stimuli. Heart rate variability (HRV) analysis has been widely used as a non-invasive tool to assess autonomic function and the balance between sympathetic and parasympathetic activity. Although the physiological interpretation of some HRV parameters remains debated-particularly the low-frequency (LF) spectral component as an index of sympathetic activation-HRV remains an important method for evaluating autonomic cardiovascular control. Reduced HRV has been associated with adverse outcomes in several pathological conditions and physiologically declines with aging, mainly due to progressive neuronal loss at central and spinal levels. Among conditions characterized by autonomic dysfunction, cardiovascular autonomic neuropathy (CAN) represents a common complication of diabetes mellitus (DM) and metabolic syndrome. CAN, defined as impairment of autonomic control of the cardiovascular system, develops early in the disease course and is associated with increased mortality and a higher risk of cardiovascular and renal complications. Sodium-glucose cotransporter 2 inhibitors (SGLT2i), initially developed as glucose-lowering agents, have demonstrated significant cardiovascular and renal protective effects beyond glycemic control. Growing evidence suggests that these drugs exert sympathoinhibitory effects that may be beneficial not only in diabetic patients but also in conditions characterized by sympathetic overactivity. Preclinical and clinical studies have shown that SGLT2i influence autonomic regulation, including sympathetic control of renal function, with reported improvements in 24-hour blood pressure regulation and HRV parameters. Large randomized trials have further confirmed the cardioprotective effects of SGLT2i therapy. Studies such as EMBODY, EMPEROR-Reduced, and EMPEROR-Preserved have demonstrated improvements in HRV indices and significant reductions in cardiovascular death and hospitalization for heart failure, irrespective of diabetic status. Despite these findings, the mechanisms underlying these benefits remain incompletely understood. While reduced sympathetic activity has been proposed as a key mechanism, emerging evidence suggests that SGLT2i may also enhance vagal modulation. Therefore, the present study aims to investigate, in a larger population, the effects of SGLT2i therapy on sympathovagal balance using both spectral HRV parameters and additional indices, including the parasympathetic nervous system index (PNSi), sympathetic nervous system index (SNSi), and the Baevsky Stress Index.

Gender: All

Ages: 18 Years - Any

Updated: 2026-03-24

Diabete Type 2
Heart Failure
Kidney Disease, Chronic
+1
RECRUITING

NCT07482072

Brain Blood Flow and Sugar Transport in Alzheimer's Disease With and Without Diabetes - A Pilot Imaging Study

Alzheimer's disease is the most common cause of dementia and affects a growing number of older adults. Although harmful proteins build up in the brain, we still do not fully understand why some brain regions are affected earlier or more severely than others. Many people with Alzheimer's disease also have problems with blood flow and sugar handling in the brain, and these changes may play an important role in disease development. People with type 2 diabetes are at especially high risk of developing Alzheimer's disease and often experience a more severe disease course. This pilot study aims to improve our understanding of how brain blood flow and sugar use are altered in Alzheimer's disease, and whether these changes differ in people with and without type 2 diabetes. We will study three groups: people with Alzheimer's disease without diabetes, people with Alzheimer's disease and type 2 diabetes, and healthy older individuals. By comparing these groups, we aim to identify early brain changes that may contribute to cognitive decline. Participants will undergo advanced brain imaging using positron emission tomography (PET) scans. One scan uses a radioactive sugar tracer to measure how the brain takes up and uses glucose. Importantly, a new non-invasive method will also allow us to estimate how efficiently glucose is transported from the blood into the brain. This is a key process that may be impaired in Alzheimer's disease, but has previously required invasive procedures. The new approach avoids arterial cannulation, making the study safer and more comfortable for participants. A second PET scan will assess brain blood flow and blood vessel function, including how well the vessels can respond to increased demand. Participants will also complete cognitive tests to assess memory and thinking abilities. Ultimately, this research may contribute to earlier diagnosis, better monitoring of disease progression, and development of new treatment strategies for Alzheimer's disease.

Gender: All

Ages: 60 Years - 90 Years

Updated: 2026-03-19

Alzheimer Dementia (AD)
Diabete Type 2
RECRUITING

NCT07469943

The Effect of Sodium Glucose Co-trnasportert Type 2 Inhibitors on Arterial Stiffness, Endothelial Glycocalyx Thickness and Cardiac Deformation After Acute Myocardial Infarction

Acute myocardial infarction (MI) remains one of the leading causes of cardiovascular morbidity and mortality worldwide. It most commonly occurs due to acute coronary artery occlusion following rupture or erosion of an atherosclerotic plaque and subsequent thrombus formation. Despite significant advances in reperfusion strategies and guideline-directed pharmacological therapy, patients who survive MI remain at increased risk for adverse cardiovascular outcomes, including heart failure, recurrent myocardial infarction, stroke, and cardiovascular death. Therefore, additional therapeutic strategies that may improve vascular function, myocardial remodeling, and overall cardiovascular prognosis following MI are of considerable clinical interest. Sodium-glucose cotransporter-2 (SGLT2) inhibitors have recently emerged as an important pharmacological class with significant cardiometabolic benefits. Large randomized clinical trials have demonstrated that SGLT2 inhibitors reduce the risk of hospitalization for heart failure and cardiovascular mortality in patients with type 2 diabetes mellitus and in patients with heart failure irrespective of diabetic status. The cardioprotective effects of these agents appear to extend beyond glycemic control and include improvements in myocardial energetics, vascular function, inflammation, and oxidative stress. Emerging evidence suggests that SGLT2 inhibitors may also exert beneficial effects on vascular stiffness, endothelial function, and myocardial remodeling. However, data regarding their potential impact on arterial stiffness, endothelial glycocalyx integrity, and myocardial deformation parameters in the early post-myocardial infarction setting remain limited. The primary aim of the present study is to investigate the effect of empagliflozin administration (10 mg daily) on arterial stiffness, endothelial glycocalyx thickness, and myocardial deformation indices of the left ventricle and left atrium during a 12-month follow-up period in patients presenting with ST-segment elevation myocardial infarction (STEMI). Secondary objectives include: 1. evaluation of the incidence of major adverse cardiovascular events (MACE), defined as cardiovascular death, recurrent myocardial infarction, and acute ischemic stroke; 2. investigation of the association between the occurrence of MACE and vascular and myocardial functional parameters, including indices of arterial stiffness, endothelial glycocalyx integrity, and myocardial strain measurements; and 3. assessment of oxidative stress burden through circulating biomarkers. This prospective observational study will include adult patients diagnosed with acute STEMI who are hospitalized in the Second University Cardiology Clinic of "Attikon" General Hospital. All participants will provide written informed consent prior to enrollment and will receive standard guideline-directed therapy for acute myocardial infarction according to the current European Society of Cardiology (ESC) guidelines. Participants will be allocated into two groups. Group A will include patients receiving empagliflozin 10 mg once daily, initiated either at hospital discharge in patients with concomitant type 2 diabetes mellitus or in patients without diabetes who present with reduced left ventricular ejection fraction (LVEF \<40%). Group B will serve as the control group and will not receive empagliflozin therapy. The anticipated sample size of the study is 80 patients, with approximately 40 participants in each group. Exclusion criteria include chronic kidney disease with estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73 m², active malignancy, autoimmune or autoinflammatory disorders, severe hepatic impairment, and pregnancy or breastfeeding. Participants will undergo detailed evaluation at baseline and at 3, 6, and 12 months. Arterial stiffness will be assessed through measurement of carotid-femoral pulse wave velocity (cf-PWV) using the Complior SP system, which represents the gold standard non-invasive method for evaluating large-artery stiffness. In addition, 24-hour pulse wave analysis will be performed using the Mobil-O-Graph device to obtain central hemodynamic parameters. Endothelial function will be evaluated through assessment of endothelial glycocalyx thickness in sublingual microvessels using Sidestream Dark Field (SDF) imaging with the GlycoCheck system. Glycocalyx integrity will be quantified by the Perfused Boundary Region (PBR) index, which reflects erythrocyte penetration into the glycocalyx layer and serves as a marker of endothelial barrier dysfunction. Cardiac structure and function will be assessed using two-dimensional speckle-tracking echocardiography. Global longitudinal strain (GLS) of the left ventricle will be calculated using the standard 17-segment model from apical views, while left atrial strain will be measured to evaluate atrial reservoir and contractile function, providing sensitive markers of myocardial remodeling after infarction

Gender: All

Ages: 18 Years - 80 Years

Updated: 2026-03-13

1 state

Myocardial Infarction (MI)
Diabete Type 2
NOT YET RECRUITING

NCT07467967

Impact of Date Consumption on Metabolic Control and Oxidative Stress in Patients With Type 2 Diabetes

Summary Dates, rich in simple sugars, fiber, and antioxidant polyphenols, have a variable glycemic index and conflicting reported effects on type 2 diabetes. Moderate consumption might raise glycemia if added to the usual diet, but could improve insulin sensitivity and oxidative balance if used as an isocaloric substitute. This prospective, interventional, single-center study (Endocrinology Department., La Rabta Hospital, Tunis) aims to evaluate the effect of daily consumption of 3 Deglet Nour dates for 8 weeks on glycemic control and oxidative stress in 130 well-controlled type 2 diabetic patients. Primary objectives: Assess changes in HbA1c, fasting glucose, and HOMA-IR. Measure variations in oxidative stress markers (MDA, SOD, TAC, pentosidine). Secondary objectives: Monitor changes in weight, BMI, waist circumference, and blood pressure. Assess tolerance, adherence, satisfaction, and adverse events. Study design: Baseline and final visits (week 0 and week 8) with clinical, dietary, and laboratory assessments. Isocaloric substitution: 3 dates replace a carbohydrate portion (e.g., fruit or dessert). No change in antidiabetic therapy or lifestyle allowed. Endpoints: Primary: ΔHbA1c, Δfasting glucose, ΔHOMA-IR, and oxidative markers. Secondary: Anthropometrics, blood pressure, safety, adherence, lipid and metabolic parameters. Expected outcome: determine whether moderate, isocaloric date consumption is safe and potentially beneficial for metabolic control and oxidative balance in Tunisian patients with type 2 diabetes.

Gender: All

Ages: 18 Years - 65 Years

Updated: 2026-03-12

Diabete Type 2
RECRUITING

NCT07467460

Precision Medicine and Neurodegenerative Diseases: Advanced Systems for the Diagnosis and Treatment of Parkinson's Disease and Alzheimer's Disease.

In recent decades, advances in medicine have significantly improved both quality of life and life expectancy. However, these positive effects are also associated with a considerable increase in the prevalence of age-related diseases. Among these, Alzheimer's disease (AD), Parkinson's disease (PD), and type 2 diabetes (T2D) currently represent a major threat to human health. PD and AD are the most common neurodegenerative diseases in industrialized populations. In particular, AD accounts for 54% of all cases of dementia, with a prevalence of 4.4% among individuals over 65 years of age. PD has a prevalence of about 1% in people older than 60 years, reaching up to 4% in those over 80 years of age. AD and PD are highly disabling disorders with a slow but progressive course, caused by the degeneration and/or death of nerve cells. This results in impairments in the control of movement and balance, as in the case of PD, or in cognitive functioning, as in AD. To date, neither effective treatments nor early diagnostic tools are available to address these conditions in the initial phase of neurodegeneration. Likewise, there are no tools capable of monitoring disease progression and improving patients' adaptation to therapy. Moreover, although the association between T2D and the risk of PD and/or AD has long been recognized, these conditions were historically considered unrelated. Recent evidence from clinical and epidemiological studies suggests the existence of shared pathophysiological mechanisms associated with insulin resistance and persistent inflammation in several metabolically relevant tissues, such as adipose tissue and the brain. However, the mechanisms that increase the risk of PD and/or AD in individuals with T2D remain poorly understood. These data highlight how relevant these diseases are for the National Health System and demonstrate that they represent one of the most important priorities to be addressed, requiring substantial investments in both scientific research and early diagnostic strategies. Therefore, the present project proposal, which aims to develop new minimally invasive tools for the early prediction and monitoring of neurodegenerative diseases such as AD and PD, will help fill an important gap in the clinical and therapeutic management of these patients.

Gender: All

Ages: 18 Years - Any

Updated: 2026-03-12

PARKINSON DISEASE (Disorder)
Alzheimer s Disease
Diabete Type 2
RECRUITING

NCT05633810

COLchicine and Non-enteric Coated Aspirin in the Cardiovascular Outcomes Trial of Patients With Type 2 Diabetes

To evaluate the efficacy and safety of colchicine and non-enteric coated aspirin, combined or alone, to improve cardiovascular outcomes in high-risk patients with type 2 diabetes.

Gender: All

Ages: 55 Years - 80 Years

Updated: 2026-03-10

21 states

Diabete Type 2
Cardiovascular Diseases
RECRUITING

NCT07415720

Artichoke By-products Rich in Hydroxycinnamic Acids and Mediterranean Diet for Type 2 Diabetes Prevention.

The ARTI-UP study evaluates whether daily consumption of a supplement made from artichoke by-products, rich in hydroxycinnamic acids (HCAs), in combination with an energy-restricted Mediterranean diet (erMeDiet), can improve glycaemic control, reduce insulin resistance and contribute to weight loss in subjects with overweight or obesity. In addition, it seeks to understand the biological mechanisms involved using omic techniques and to establish predictive biomarkers that will enable progress towards personalised nutrition strategies.

Gender: All

Ages: 18 Years - 75 Years

Updated: 2026-02-17

1 state

Diabete Type 2
Obesity & Overweight
Insulin Resistance Syndrome
RECRUITING

NCT05776420

Effect of a Healthy Food Voucher on Blood Glucose Control in People With Type 2 Diabetes or Prediabetes

This randomized controlled trial (RCT) will determine if access to a voucher for healthy foods reduces blood sugar levels among people living on a low income who have type 2 diabetes or elevated blood sugar.

Gender: All

Ages: 19 Years - Any

Updated: 2026-02-10

Diabete Type 2
NOT YET RECRUITING

NCT07373392

Effects of LP-LDL® on Lipid Metabolism, Glycemic Control, Inflammatory Markers, and Cognitive Function in Individuals With Prediabetes and Diabetes Mellitus

This randomized, double-blind, placebo-controlled clinical trial investigates the effects of the probiotic LP-LDL® (Lactobacillus plantarum ECGC 13110402) on lipid metabolism, glycemic control, inflammatory biomarkers, and cognitive function in adults with prediabetes, type 1 diabetes, or type 2 diabetes who also exhibit elevated cholesterol or triglyceride levels. A total of 210 participants will be enrolled across three parallel sub-studies: * Type 1 diabetes (n = 76) * Type 2 diabetes (n = 54) * Prediabetes (n = 80) Participants will be randomized 1:1 to receive LP-LDL® or matching placebo once daily for 12 weeks, followed by a 4-week washout period. Study assessments include fasting blood tests (lipids, glucose, HbA1c, liver enzymes, inflammatory markers), cognitive testing (ACE-III), blood pressure, anthropometry, and stool measurements (microbiome, bile acids, fecal fat). Exploratory analyses include bile acid metabolism, microbiome profiling (16S rRNA), and gene expression of cholesterol transporters ABCG5/ABCG8. The study aims to determine whether LP-LDL® can improve cardiometabolic profiles and cognitive outcomes in these populations, and to clarify the mechanistic pathways underlying metabolic dysfunction, inflammation, and gut-brain communication.

Gender: All

Ages: 18 Years - Any

Updated: 2026-01-29

Diabete Type 1
Diabete Type 2
Prediabetes
ACTIVE NOT RECRUITING

NCT07303556

Improving Cardiovascular Disease Diagnosis and Treatment in Kazakhstan Using Metabolic Correction With GLP-1 Drugs

This clinical study aims to improve the diagnosis and treatment of cardiovascular diseases in Kazakhstan by Implementing Metabolic Correction with Glucagon-Like Peptide-1 (GLP-1). These medicines are called incretin-based therapies and include GLP-1 receptor agonists and a newer dual therapy that targets both GIP and GLP-1 receptors. Such medications have already shown benefits in lowering blood sugar, reducing body weight, improving blood pressure, and lowering the risk of serious heart complications. Cardiovascular diseases and diabetes are among the most common health problems in Kazakhstan. Many patients remain undiagnosed or receive treatment only after their condition becomes severe. This study seeks to address these challenges by testing how well dual incretin therapy works in improving heart health, blood sugar control, and overall metabolic status in adults who have both chronic heart failure and type 2 diabetes. Participants in the study will receive a detailed health evaluation at the beginning, including heart tests, blood work, and genomic profiling. Genomic testing will help researchers understand whether certain genetic features affect how patients respond to this therapy. After the initial assessment, participants will start treatment with a GIP/GLP-1 receptor agonist and will be monitored every few months for a total of 40 weeks. During these visits, their heart function, blood sugar levels, weight, and other health indicators will be checked to ensure both safety and effectiveness. The main hypothesis of the study is that dual incretin therapy will improve heart function, reduce cardiometabolic risks, and show measurable benefits in patients with both chronic heart failure and type 2 diabetes. The study also assumes that a person's genetic profile may influence how well they respond to treatment. By the end of the project, researchers hope to better understand how these medications work in the Kazakhstani population and to use these findings to support more personalized, effective, and modern approaches to treating cardiovascular diseases.

Gender: All

Ages: 18 Years - 75 Years

Updated: 2026-01-28

1 state

Heart Failure
Diabete Type 2
Arterial Hypertension
RECRUITING

NCT07164495

Risk Factors for Developing Peak Plantar Pressure During Walking in the Diabetic Patients

The goal of this observational study is to investigate the clinically convenient dynamic and static measurement parameters to identify related risk factors of developing high peak plantar pressure during walking in the type-2 diabetic patients, and then establish a predictive model to estimate the likelihood of excessive plantar pressure. The main question it aims to answer is: Which clinical measurements may be used as the predictors that increased peak plantar pressure in the type-2 diabetic patients? Participants taking the examinations will understand their own clinally meaningful measurements related to their plantar pressure during walking. Further thorough analysis will be employed to develop a predictive model, aiming to provide potential improvement strategies for preventing diabetic foot ulcers in the future.

Gender: All

Ages: 18 Years - Any

Updated: 2026-01-28

1 state

Diabete Type 2
RECRUITING

NCT07372677

Pocket-X Gel Non-surgical Periodontal Therapy

Evaluate from a clinical and microbiological point of view the effect of an adjunctive therapy based on a thermal-gelling device Pocket-X® Gel (Hyaluronic acid, Poloxamer, 2-Phenoxyethanol, Octedine HCL, Water), in the non-surgical treatment of periodontal defects, in a population of patients with T2DM compared to non-diabetic patients. Determine whether periodontal defect healing is clinically and microbiologically different between T2DM patients and non-diabetic patients; whether periodontal treatment and maintenance can lead to improvement of conditions and stability over time also for diabetic conditions.

Gender: All

Ages: 18 Years - 80 Years

Updated: 2026-01-28

1 state

Diabete Type 2
NOT YET RECRUITING

NCT07365358

Evaluate the Efficacy and Safety of Empagliflozin or Glimepiride Combination Therapy in Type 2 Diabetes Mellitus Patients

The purpose of this study is to evaluate the efficacy and safety of Empagliflozin or Glimepiride Combination Therapy in Type 2 Diabetes Mellitus Patients

Gender: All

Ages: 19 Years - Any

Updated: 2026-01-26

Diabete Type 2
NOT YET RECRUITING

NCT07344324

Study Evaluating the Safety and Feasibility of Endoscopic Duodenal Injections of Autologous Mesenchymal Stem Cells

Type 2 Diabetes Mellitus (T2DM) pathogenesis increasingly involves "diabetic duodenopathy," characterized by proximal intestinal immune and epithelial dysregulation. This study investigates the endoscopic delivery of adipose-derived mesenchymal stem cells (ADMSCs) into the duodenum and proximal jejunum as a disease-modifying therapy. By leveraging the paracrine immunomodulatory and regenerative effects of ADMSCs in close proximity to the pancreatico-enteroendocrine system, this targeted approach aims to restore insulin sensitivity and $\\beta$-cell function while minimizing systemic exposure. The clinical safety and feasibility of this novel delivery route remain to be established.

Gender: All

Ages: 25 Years - 70 Years

Updated: 2026-01-15

Diabete Type 2
Insulin Resistant Diabetes (Mellitus)
Obesity
RECRUITING

NCT07212075

Precision Subclassification of Mental Health in Diabetes: Digital Twins for Precision Mental Health to Track Subgroups

Mental conditions and disorders (e.g. distress, depressive, anxiety, and eating disorders) are more prevalent in people with diabetes (PWD) and associated with reduced quality of life and impaired glycaemic outcomes. Evidence supports a complex network between psychosocial factors and glycaemic control that can be highly variable between persons. It is assumed that subgroups exist that show different trajectories of glycaemia and mental health. Belonging to a particular subgroup may be linked with a higher risk of developing mental health problems compared to others. This suggests that it is possible to treat individuals in different subgroups in a manner that optimizes their treatment and can improve health outcomes. Accurate characterisation can inform more individualized care. This calls for a more personalised approach considering the idiosyncrasies of different subgroups. Over 3 years, the investigators have established the basis of a precision mental health approach for diabetes using n-of-1 analyses. By utilizing combined ecological momentary assessment (EMA: repeated daily sampling of psychosocial factors in everyday life) and continuous glucose monitoring (CGM), intensive longitudinal data per person could be collected. This enables the analysis of individual associations between glycaemic parameters and psychosocial variables and identification of individual sources of diabetes distress in each person. The objective of the present study is to use of the n-of-1 approach to identify subgroups of PWD who share common characteristics in the associations between glucose and psychosocial variables. The identified subgroups shall be used to develop a digital twin for precision mental health in diabetes. The digital twin serves as representation of a real person, allowing to make simulations and predictions of the course of mental health and glycaemia. These predictions can inform diabetes care and lead to more precise, personalised treatment decisions. To achieve this, a longitudinal panel including over 1,400 PWD who continuously complete EMA and questionnaire surveys and measure glucose levels using CGM was developed. Over 1000 clinical interviews to diagnose mental disorders have been conducted to identify major mental health conditions and map mental outcomes. To identify subgroups and develop the digital twin, the sampling will be expanded aiming at a total of 1,809 PWD. Incidence and remission of mental disorders will be determined via repeated interviews. The complex networks between clinical, metabolic, and psychosocial data will be analysed using machine learning, leading to new insights with the potential to shape future guidelines. These results will be used by the digital twin to predict courses of glycaemic control and mental health, translating the individual evidence into direct treatment suggestions.

Gender: All

Ages: 18 Years - 80 Years

Updated: 2025-12-04

1 state

Diabetes (DM)
Diabete Mellitus
Diabete Type 1
+17
ACTIVE NOT RECRUITING

NCT07250607

Extreme Phenotypes to Identify Susceptibility of Patients Living With Type 2 to Diabetes Related Complications

The goal of this observational study is to learn more about the diverse susceptibility to micro and macrovascular complications in individuals living with Type 2 Diabetes (T2D). The main questions of the study are: * Is the chronic exposure to hyperglycemia the only determinant of diverse susceptibility to diabetes related complications (DRC) across the T2D population? * Is it possible to develop a reliable tool to identify patients at different susceptibility to DRC? * Is it possible to predict DRC susceptibility through biomarkers in the field of inflammation, hormonal signaling or non-coding circulating nucleotides. People living with T2D and well screened for complications according to the international recommendations (American Diabetes Association/European Society for the study of Diabetes) will be included in the survey collecting information about chronic exposure to hyperglycemia (diabetes duration + glycemic control) and incidence and severity of each macro and microvascular complication. Based on the survey result, a clinical score will be proposed to distinguish patient at different susceptibility to complications. Then, patients with extreme phenotypes of susceptibility (i.e. those with highest susceptibility for their short exposure to hyperglycemia vs those with lowest susceptibility to complication for their long exposure to hyperglycemia) will be recruited to perform a blood drawn and investigate whether preidentified potential biomarkers could describe the diverse susceptibility to DRC by showing a significant gradient between groups.

Gender: All

Ages: 40 Years - 80 Years

Updated: 2025-11-26

3 states

Diabete Type 2
Diabetes Complications
NOT YET RECRUITING

NCT07213843

Combined Circulatory and Dietary Interventions for Neuropathy

The purpose of this study is to evaluate the effectiveness of three different interventions in improving neuropathy symptoms in individuals aged 35-85 with moderate to severe neuropathy. The study will compare three treatment groups: Intraneural Facilitation® (INF®) therapy alone, INF® therapy combined with Neuro vascular index (NVI) food-guided elimination (NVIf), and NVIf alone. The aim is to determine which treatment results in the greatest improvement in neuropathy symptoms, including quality of life, sensory and pain improvements, and functional outcomes.

Gender: All

Ages: 35 Years - 85 Years

Updated: 2025-10-09

1 state

Diabete Type 2
Neuropathy, Painful
ENROLLING BY INVITATION

NCT07190378

Predictive Factors and Monitoring Strategies in Steroid-Induced Diabetes

Glucocorticoids are widely used in the management of autoimmune, inflammatory and neoplastic conditions. However, they are associated with significant metabolic effects, including steroid-induced diabetes (SID). SID is typically diagnosed using general criteria for type 2 diabetes, which may be inadequate due to the unique glycemic profile often seen in SID, where postprandial hyperglycemia predominates. This research aims to explore the diagnostic value of CGM during steroid therapy and identify risk factors for SID This is a prospective observational study (n=250) enrolling adults initiating glucocorticoid therapy. Participants will undergo 14-day continuous glucose monitoring (CGM) to assess predictive factors and glycemic profile.

Gender: All

Ages: 18 Years - Any

Updated: 2025-10-01

1 state

Steroid-Induced Diabetes
Diabete Type 2
Steroid Induced Hyperglycemia
NOT YET RECRUITING

NCT07198516

The Improvement Effect of Henggliejin on Fatty Liver in Type 2 Diabetes Patients With Nonalcoholic Fatty Liver:

To evaluate the effect and safety of Henggliejin on fatty liver in type 2 diabetes patients with nonalcoholic fatty liver disease

Gender: All

Ages: 18 Years - 70 Years

Updated: 2025-09-30

NAFLD
Diabete Type 2
RECRUITING

NCT07093476

Efficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and Metformin

Phase 3 study to assess the Efficacy and Safety of CT-L02-301 in Type 2 Diabetes Patients with Insufficient Glycemic Control with Metformin and Alogliptin Combination Therapy.

Gender: All

Ages: 19 Years - Any

Updated: 2025-08-11

T2DM
Diabete Type 2
DM