Clinical Research Directory

Differentiating Heart Disease Between Adult-onset Autoimmune and Type 2 Diabetes

Background: The study of factors associated with diabetic heart disease (DHD), the leading cause of mortality in diabetes, represents an unmet need. Autoimmune diabetes in adults (AID) and type 2 diabetes (T2D) differ in pathophysiology, vascular complications, and autonomic impairment, with significant implications for DHD, which results from a complex interplay among coronary micro- and macro-vascular circulation, neuro-immune control, and myocardial damage. Objective: To characterize the complexity of DHD and its determinants by comparing AID and T2D. Methods: DHD will be studied in individuals with AID, T2D, and healthy controls matched for cardiovascular risk factors. Advanced echocardiography and cardiovascular magnetic resonance will allow high-quality assessment of the different components of DHD (such as cardiac geometry, performance, and contraction). To identify the determinants of DHD, cardiac study results will be correlated with autonomic dysfunction tests, markers of small fiber neuropathy, and laboratory assessments of metabolic alterations, cardiac autoimmunity, and the inflammasome. Furthermore, genetic susceptibility to autoimmune diabetes and pancreatic autoimmunity will also be evaluated and correlated with DHD

Study of the Safety and Efficacy of Pancreatic Endocrine Cells in Adult Patients With Type 1 Diabetes

This study will evaluate the safety, efficacy and durability of SR-02 administered to the omentum of patients of Type 1 diabetes with severe recurrent hypoglycemia. The study will also help establish the optimal treatment dose. Although this study is open to patients with all HLA or blood types, immunosuppression to prevent rejection will be required in this first in human study.

Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years

Overweight and obesity, as well as periodontitis, are common public health problems with increasing prevalence. Both conditions may be linked through shared mechanisms involving chronic low-grade systemic inflammation. Numerous studies have reported an association between elevated body mass index (BMI) and periodontitis, particularly among younger and working-age populations. However, data regarding Thai adults under the age of 60 remain limited. Therefore, this study aims to determine the prevalence of high BMI and periodontitis among Thai adults aged 18-59 years and to identify factors associated with these conditions. The findings may provide useful information for improving awareness and supporting the prevention of both periodontal and general health problems in this population.

Hypertension Treatment in Nigeria: Hypertension Diabetes Integration Study- Formative Aim 3

The purpose of the second phase of the Hypertension Treatment in Nigeria (HTN 2.0) Program is to build upon the success of the first phase of the HTN Program (2020-2023), which implemented the WHO HEARTS package across 60 primary healthcare centers (PHCs) in the Federal Capital Territory (FCT). This program demonstrated significant improvements in hypertension treatment and control. The focus of aim 3 will be evaluating diabetes management through the implementation of the HEARTS-D bundle in 10 PHCs across the FCT that previously participated in the initial HTN Program.

Effectiveness of a Multimodal Cognitive Rehabilitation Protocol Combined With Mechanical Periodontal Therapy in Diabetic Patients With Cognitive Impairment

Type 2 diabetes mellitus (T2DM) is strongly associated with an increased risk of cognitive impairment via multiple, converging pathways chronic hyperglycemia, insulin resistance, and vascular injury leading to deficits in memory, attention, and executive functions. Large-scale reviews and epidemiologic syntheses note high prevalence of mild cognitive impairment (MCI) in diabetes and underscore the need for targeted interventions that address metabolic and neurocognitive mechanisms simultaneously.

A Study of Fresh Produce and AI-Enabled Nutrition Support in Adults With Diabetes in Rural Appalachia

This pilot study evaluated a 12-week program for adults with type 2 diabetes and food insecurity living in rural Tennessee. Participants were randomly assigned to one of two groups. The program provided fresh fruits and vegetables delivered to participants' homes and nutrition support through text messages. The text messages provided information and support related to healthy eating, using and preparing fresh produce, meal planning, goal setting, and community resources. The study examined whether the program was feasible and acceptable to participants and explored changes in diabetes management, food security, eating behaviors, and health outcomes.

RESET-INSPIRE Study: Insulin Sensitivity & Population Intervention With Real-time Evaluation Using CGM

The RESET-INSPIRE study is designed to investigate individual variability in glucose response and insulin sensitivity, a key mechanism underlying metabolic-associated steatotic liver disease (MASLD) and cardiometabolic disorders. Building on findings from Project RESET, this study aims to develop and validate a continuous glucose monitoring (CGM)-based approach for assessing insulin sensitivity.

Effect of mHealth Intervention on Oral Health-Related Quality of Life Among Adult Patients With Chronic Systemic Diseases

This study evaluated whether an mHealth oral health education intervention could improve oral health-related quality of life among adults with chronic systemic diseases registered in specialized disease centers in Al-Ahsa, Saudi Arabia. Adults with type 1 diabetes mellitus, cardiovascular disease, chronic kidney disease, or hereditary blood disorders were included. Participants were assigned to either an intervention group or a control group. Both groups continued to receive routine care. The control group received a standardized printed oral health education leaflet, while the intervention group received an mHealth oral health education program consisting of five educational videos covering toothbrush and fluoride toothpaste selection, toothbrushing technique, dental flossing, tongue cleaning, and water flosser use. The educational materials were delivered electronically through a secure web-based platform, with links sent through WhatsApp at regular intervals during the 3-month intervention period. Oral health-related quality of life was assessed using the validated Arabic version of the 14-item Oral Health Impact Profile (OHIP-14) at baseline, 1 month, and 3 months. The main hypothesis was that participants receiving the mHealth intervention would show greater improvement in oral health-related quality of life over the 3-month study period compared with participants receiving the control condition.

A Cluster-Randomized Controlled Trial

The goal of this study is to learn if an AI-generated personalized health report combined with face-to-face guidance from cardiologists can help rural adults with high blood pressure control their blood pressure better and reduce heart attacks and strokes. It will also assess the safety and practicality of this approach. The main questions it aims to answer are: Does this intervention increase the proportion of patients who achieve blood pressure below 130/80 mmHg at 18 months? Does it lower the rate of major cardiovascular events (heart attack, stroke, heart failure hospitalisation, or cardiovascular death) over 48 months or longer? Does it improve medication adherence, blood pressure levels, and health knowledge, and is it cost-effective? Researchers will compare three groups of townships: one receiving the full AI-plus-cardiologist intervention, one receiving the same follow-up and education but without the AI report and cardiologist consultation, and one continuing with usual local care. Participants will: Attend regular clinic visits for blood pressure measurements, lab tests, and questionnaires. If in the intervention group, receive an AI-generated personalised health report and a face-to-face consultation with a cardiologist, plus home blood pressure monitoring guidance and health education. Be followed for 48 months or longer to track their blood pressure and any cardiovascular events. All medications used are standard, widely approved blood pressure drugs; side effects are mild and manageable, and participants will be closely monitored. Participation is voluntary, and all personal data will be kept confidential. The study has ethics approval, and informed consent will be obtained from all participants.

Feasibility & Implementation of a Plant-Based Weight-Loss Program in an Office-Based Setting

This prospective study aims to assess the feasibility and implementation of a plant-based, weight-loss program in an office setting. The study will also assess changes in body weight, blood pressure, plasma lipids, glycated hemoglobin, and body composition with a 12-week, plant-based, weight-loss program. These health benefits may illustrate feasibility to physicians and healthcare professionals elsewhere.

Duodenal pulsENDO as an Early Treatment for Type 2 DM

This study is designed to evaluate the efficacy and safety of endoscopic duodenal re-cellularization therapy using pulsed electric field in individuals with in patients with a recent diagnosis of type 2 diabetes mellitus (T2DM).

Hair Changes in Females With Type 2 Diabetes Clinical and Trichoscopic Examination

The aim of this thesis is to investigate the effect of diabetes mellitus on hair by assessing and comparing clinical and dermoscopic hair changes in diabetic patients versus age and sex-matched healthy controls.

Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds

Diabetic foot ulcer (DFU) is a leading cause of hospitalization, disability, and mortality among diabetic patients, imposing a substantial burden on both patients and national healthcare resources. Despite the availability of comprehensive multidisciplinary treatment approaches, the wound healing rate for DFU remains only approximately 50%. Therefore, the development of novel technologies for DFU wound management represents an urgent scientific priority.Our team has been dedicated to the DFU field for over 22 years and has established a well-maintained DFU follow-up cohort and a comprehensive biospecimen repository. In our preliminary work, we employed multi-omics approaches to analyze the microbial community structure and metabolite profiles of DFU wounds. Furthermore, we investigated the mechanisms of turmeric-derived nanoparticle aerogel (TAG) in DFU wound infection and tissue repair based on the wound microenvironment. These findings were published in Advanced Science in 2024.Building upon this foundation and utilizing a turmeric-derived hydrogel formulation, we plan to conduct a randomized, multi-center, parallel-controlled, prospective clinical study (N=54). This trial aims to evaluate the efficacy of TAG as an adjunct to standard care in promoting target ulcer healing and reducing recurrent infections in patients with Wagner grade 1 to 3 DFU, with the goal of optimizing clinical practice in DFU wound management.

Comparing Two Low-Carbohydrate Diets With a Standard Diet in Type 2 Diabetes

Type 2 diabetes is often accompanied by high blood triglycerides and excess weight, and diet plays a central role in managing these conditions together. The purpose of this study is to compare the effects of two moderate low-carbohydrate diets - one higher in protein and one higher in fat - against a standard diet, on blood sugar control, blood lipids (especially triglycerides), body weight, and blood pressure in adults with type 2 diabetes, hypertriglyceridemia, and overweight or obesity.

A Clinical Study to Evaluate the Safety and Efficacy of RGB-5088 in Patients With Type 2 Diabetes Mellitus

This Phase I clinical trial is a multi-center, single-arm, open-label study aimed at evaluating the safety and efficacy of RGB-5088 islet cell infusion in patients with Type 2 Diabetes Mellitus.

E-Health Literacy Intervention for Bangladeshi Migrants With Type 2 Diabetes in Italy

This study is testing a training program for people from the Bangladeshi community of Ancona in the Marche Region (Italy) who have type 2 diabetes. Many people in this group find it hard to understand health information, including how to use digital health tools. This is called low health literacy. Low health literacy can make it harder to manage diabetes well. The goal of this study is to find out if the training program improves health literacy and confidence in managing diabetes. About 50 adults with type 2 diabetes from the Bangladeshi community are taking part. They are followed by the diabetes clinic at the University Hospital of the Marche Region in Ancona. Before training started, patients, caregivers, and health workers helped design the program together. This made sure the training fit the community's needs and culture. Participants complete a training program with four short modules. The modules cover diabetes, health literacy, and digital skills for managing diabetes. Researchers measure health literacy, digital skills, and confidence in managing diabetes before training, right after training, and again after 1 month and 6 months. This shows whether the improvements last over time. This study is part of JACARDI, a European project working to reduce diabetes and heart disease across Europe.

Ultrasonic Enhancement Delivery of Phosphodiesterase Inhibitors Nanoparticles for Diabetic Management of the Foot

The enhancement of cGMP levels at the wound site has shown beneficial effects in wound healing. Thus, topical or systemic application of phosphodiesterase 5 (PDE5) inhibitors, for example, sildenafil (Viagra), which is well-known for its use in the treatment of erectile dysfunction, enhanced contraction, re-epithelialization, and tensile strength of rat wounds and reduced pressure ulcer size in a few patients. In addition, Nanofibers Specifically designed for topical drug delivery enable the sustained release of therapeutic molecules, such as growth factors. This targeted approach ensures optimal cell-to-cell interactions, proliferation, and vascularization, fostering effective and controlled wound healing. Diabetic foot is Diabetic foot ulcers (DFUs) are the most common complications associated with diabetes mellitus. DFUs are displayed as open sores or wounds on the bottom of the foot as a secondary complication of diabetes mellitus (DM). DFUs are associated with significant morbidity and mortality and can subsequently lead to hospitalization and lower limb amputation if not recognized and treated on time. An immense challenge to conventional treatments is caused by the chronic nature of diabetic foot syndrome, and it has led to the emergence of nanotechnology-based therapeutics.

Effectiveness and Utility of Telemonitoring in Improving the Glycaemic Control of Diabetes Mellitus Tunisian Patients

The study aims to evaluate the impact of a telemonitoring system on glycemic control in patients with diabetes in Tunisia. Participants in the intervention group will receive remote diabetes management through a dedicated mobile application and web platform, while the control group will receive standard diabetes care. The primary objective is to determine the effectiveness of telemonitoring in improving glycemic control, as assessed by changes in glycated hemoglobin (HbA1c) and blood glucose levels.

Cardiovascular-kidney-metabolic (CKM)-Guided Therapy for Patients After Acute Coronary Syndrome

Patients with a history of myocardial infarction are at significantly increased risk of recurrent cardiovascular events. Despite established clinical guidelines, secondary preventive care is often initiated too late, inadequate in intensity or incomplete in application. As a result, important opportunities to prevent serious outcomes are missed. The aim of this project is to investigate whether rapid, guideline-based treatment following myocardial infarction leads to improved patient outcomes. The study protocol is based on current clinical guidelines and targets key domains including diabetes, hypertension, and hypercholesterolemia. Outcomes of patients treated according to the study protocol will be compared to those receiving standard care. Primary endpoints include major adverse cardiac- and cerebrovascular events within a 24-month follow-up period. The investigators hypothesize that rapid, guideline-based intervention will result in improved risk factor management, leading to a reduction in cardiovascular events and mortality. For patients, this may translate into improved health, quality of life and life expectancy. This project aims to deliver a practical protocol for effective secondary prevention in clinical practice, which is expected to reduce healthcare utilization in the long term. With this initiative, the investigators seek to take a significant step toward improving post-myocardial infarction care and contributing to sustainable cardiovascular healthcare.

Application of Growth Factors Derived From Platelets to Accelerate Healing and Reduce Post-extraction Complications in Diabetic Individuals

To evaluate soft tissue closure in diabetic extraction sockets using digital scans. To compare healing between sockets treated with Advanced Platelet Rich Fibrin (A-PRF) vs. untreated control sites. To assess post-operative discomfort and patient satisfaction.

Assessing the Effectiveness of Large Language Model (LLM)-Enabled Nurse Treatment Planning in 2 Indian Districts

The goal of this clinical trial is to learn whether AI-enabled, nurse-led treatment planning can improve the quality of clinical reasoning and management compared with standard physician-led care in adult primary care patients (≥18 years) presenting with hypertension, diabetes mellitus, fever, breathlessness, or musculoskeletal pain in rural and semi-urban India. The main questions it aims to answer are: * Does a nurse + large language model (LLM) consultation achieve non-inferior clinical quality scores compared with a standard doctor consultation? * Is AI-assisted nurse-led care acceptable and satisfactory to patients in primary healthcare settings? Researchers will compare nurse + LLM-led consultations with physician-led standard-of-care consultations within the same participant to see if the AI-enabled nurse model delivers comparable or improved clinical reasoning and treatment planning. Participants will: * Receive two sequential consultations for the same visit (one with a nurse using an AI tool and one with a physician, order randomized). * Have both consultations audio recorded for blinded clinical quality assessment. * Complete a brief exit survey on communication, trust, and satisfaction after the AI-assisted nurse consultation.

Inflammation and Diabetes: Evaluating Antioxidant Levels

The goal of this observational, cross-sectional study is to evaluate the relationships between dietary total antioxidant capacity, systemic inflammatory response markers, and nutritional parameters in adult patients with Type 2 Diabetes (T2DM). Participants will be classified into controlled (HbA1c \< %7) and uncontrolled (HbA1c ≥ %7) diabetes groups based on their glycemic control. The main questions it aims to answer are: Does dietary antioxidant capacity affect systemic inflammation levels and metabolic parameters? Is there a relationship between nutritional risk status and inflammatory response in T2DM patients?

Nephroprotective Effects of Fig (Ficus Carica L.) Leaf Supplementation

Diabetic nephropathy is the result of diabetes complications. Excessive blood glucose levels affect several organs which include liver, heart, and kidneys.The aim of this study is to use the nephroprotective and metabolic effects of fig (Ficus carica L.) leaf supplementation with a low glycemic index diet in grade-II chronic kidney disease patients.

Amelioration of Lipid Profile Through Date Cider-vinegar Along With 5:2 Intermittent Fasting

A common metabolic abnormality in hyperglycemic individuals, dyslipidemia is strongly linked to an increased risk of cardiovascular illness. This study looked at how date cider vinegar and 5:2 intermittent fasting affected the lipid profile and metabolic indices of hyperglycemic patients