Clinical Research Directory

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.

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.

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).

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.

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.

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.

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

Effect of Tirzepatide on Diabetic Peripheral Sensorimotor Neuropathy

Tirzepatide is a dual agonist of GLP-1 Receptor and the GIP receptor, producing substantial improvement in glycaemic control, weight reduction and insulin sensitivity. Beyond its metabolic effects, incretin signalling has demonstrated neuroprotective and neurotropic properties, including activation of intracellular pathways that enhance neuronal survival and regeneration. Using tirzapatide for diabetic sensorimotor peripheral neuropathy and assessing with CCM / NCS and BDNF will represent three complementary aspects of nerve regeneration: metabolic control, structural nerve repair and neurotrophic signalling.

The Effect of SPU on Hormonal and Cardiometabolic Factors

The study examines the immediate effect of soleus pushup exercise on cardiometabolic and hormonal functions among hypothyroid patients.

Effect of Curd Cheese on Metabolic Health in Adults

This randomized controlled trial aims to evaluate the effects of a diet supplemented with curd cheese on anthropometric measurements, glycemia, and lipid profile in overweight adults. Participants aged 40-64 years with a BMI above 25 will be randomly assigned to an intervention group receiving 100 g of curd cheese at breakfast for 8 weeks or to a control group receiving a standard healthy diet without curd cheese. Primary outcomes include changes in fasting blood glucose and HbA1c, while secondary outcomes are changes in body composition, waist circumference, and lipid profile (HDL, LDL, triglycerides, total cholesterol).

Impact of Pilates Exercises on Diabetic Erectile Dysfunction.

Erectile dysfunction (ED) has a prevalence of 52.5% in diabetic male patients, as described in a meta-analysis of 145 studies, including 88,577 men with type 1 and type 2 diabetes. In men, ED can cause sexual dissatisfaction and distress, unsatisfactory relationships, and marital tension

Oral Health and Systemic Diseases: Survey of General Practitioners

This cross-sectional observational study aims to assess the level of knowledge, clinical practices, and professional attitudes of General Practitioners (GPs) regarding oral health and its relationship with major systemic diseases, with particular emphasis on periodontal disease. Data will be collected through an anonymous, self-administered digital questionnaire distributed nationwide to General Practitioners practicing in Italy. The questionnaire will investigate participants' knowledge of oral diseases, awareness of oral-systemic associations, early identification of oral manifestations, educational background, and interdisciplinary collaboration with dental professionals.

Clinical Information System Impact on Hospitalized Patients With Chronic Disease

This is a retrospective, observational study using routinely collected information collected by Alberta Health Services. The study will identify patients with chronic disease, defined by one or more of the following conditions; diabetes mellitus, heart failure, coronary artery disease, chronic kidney disease, or chronic lung disease. Adult residents of Alberta with a chronic disease of interest present upon hospital admission and who survive to hospital discharge will be included in the study cohort. The primary outcome will be the composite of hospital readmission or death within 30 days of discharge. Secondary outcomes will include components of the composite, length of stay, patient experiences related to their hospital to home transition of care, and processes of care. Multi-level interrupted time series analysis will be used to compare outcomes before versus after implementation of the Connect Care CIS.

The Role Intraoperative Salbutamol Inhaler in Preventing Atelectasis

Atelectasis is considered a common complication in the perioperative period, especially following surgeries under general anesthesia. Postoperative atelectasis could occur anytime during the perioperative period from intraoperative period to 24 hours postoperative and contribute to a variety of other complications, including hypoxemia and pneumonia. In the literature, several methods were utilized to combat this phenomenon, therefore, we investigate the role of intraoperative salbutamol in reducing the incidence of atelectasis. It is well known that salbutamol could be an adjunctive bronchodilator medication used in the intraoperative anesthetic regimens.