Clinical Research Directory

Evaluation of MTHFR and DNMT3B Gene Polymorphisms Along With Periodontal Clinical Parameters in Healthy Individuals and Individuals With Type 2 Diabetes and Periodontitis

Periodontitis is a chronic inflammatory disease that affects the tissues supporting the teeth and can lead to progressive tissue destruction. Type 2 diabetes mellitus is a metabolic disease characterized by persistently elevated blood glucose levels. These two conditions are closely related, and genetic factors may influence their development and severity. This observational study aims to evaluate the distribution of methylenetetrahydrofolate reductase (MTHFR) and DNA methyltransferase 3B (DNMT3B) gene polymorphisms in healthy individuals, individuals with periodontitis, individuals with type 2 diabetes mellitus, and individuals with both conditions. The study also aims to investigate the associations between these genetic variations and periodontal clinical parameters. The study includes 200 participants divided into four groups of 50 individuals each: healthy individuals, individuals with type 2 diabetes without periodontitis, individuals with periodontitis without type 2 diabetes, and individuals with both type 2 diabetes and periodontitis. Periodontal examinations include the assessment of plaque index, gingival index, probing pocket depth, clinical attachment loss, and gingival recession. Venous blood samples are collected for molecular analysis of MTHFR and DNMT3B gene polymorphisms. The findings may contribute to a better understanding of the potential role of genetic factors in periodontal disease and its relationship with type 2 diabetes mellitus.

Tolerability and Safety of Nano-Tocotrienols

The goal of this randomised controlled trial is to determine the long term safety and tolerability of nano-tocotrienols (50 - 400 mg/day for 6-months duration) to be used as a health supplement in both healthy individuals and those with Type 2 diabetes mellitus. The study will compare patients (both healthy and individuals with Type 2 diabetes mellitus) receiving placebo and those receiving nano-tocotrienols. They would then be followed up at 3 months and 6 months intervals to determine if there is any adverse events experienced with the supplement.

A Study of VCT220 Tablets in Adults With Type 2 Diabetes and Inadequate Blood Glucose Control

This study will evaluate whether VCT220 tablets improve blood glucose control in adults with type 2 diabetes whose blood glucose remains inadequately controlled with lifestyle intervention alone, metformin alone, or metformin combined with a sodium-glucose cotransporter 2 (SGLT2) inhibitor. The study will also assess safety, tolerability, and how VCT220 is processed by the body. Approximately 120 participants will be randomly assigned in equal proportions to VCT220 40 mg, 80 mg, 120 mg, or placebo, taken orally once daily for 16 weeks. Higher-dose groups will start at 40 mg and increase the dose in steps. Participation will last approximately 22 weeks, including screening, a placebo run-in period, treatment, and safety follow-up. The main assessment is the change in glycated hemoglobin (HbA1c) from baseline to Week 16.

Effect of Otago vs. Sensorimotor Training on Balance and Fall Risk in People With Diabetes

The purpose of this study is to compare the effects of the Otago Exercise Program versus Sensorimotor Training on dynamic postural stability and risk of fall in patients with type 2 diabetes mellitus. Participants will be randomly assigned into two equal intervention groups. One group will receive the Otago Exercise Program, while the other group will receive Sensorimotor Training. Both groups will participate in their respective exercise protocols for 8 weeks. Dynamic postural stability and the risk of falling will be assessed before and after the intervention period using standardized physical therapy evaluation tools.

Preoperative Gastric Volume and High-Risk Gastric Content in Patients With Type 2 Diabetes Mellitus

This prospective observational study will evaluate adult patients with type 2 diabetes mellitus who are scheduled for elective surgery. Immediately before preoperative gastric ultrasonography, capillary fasting blood glucose will be measured. Gastric contents will be assessed qualitatively in the supine and right lateral decubitus positions, and residual gastric volume will be estimated using the antral cross-sectional area measured in the right lateral decubitus position. The primary objective is to evaluate the association between fasting capillary blood glucose and the presence of a high-risk stomach. A high-risk stomach will be defined as the presence of solid gastric contents, Perlas Grade 2 gastric contents, or an estimated gastric volume greater than 1.5 mL/kg. Secondary objectives include determining the prevalence of a high-risk stomach and evaluating its associations with demographic characteristics, diabetes-related factors, comorbidities, fasting duration, medication use, gastroparesis-related symptoms, and routine laboratory parameters.

Proteome-Wide Association and LLM-Based Prioritization of Type 2 Diabetes Protein Targets

Type 2 diabetes is a common condition in which the body has difficulty controlling blood sugar. This study will use existing genetic, protein, and health data from prior research studies to identify blood proteins that may play a role in type 2 diabetes. The study will not recruit participants, provide treatment, or collect new samples. Researchers will use computer-based analyses to identify and prioritize protein targets for future laboratory and clinical research. The goal is to support the development of better approaches for understanding, preventing, and treating type 2 diabetes.

Nature Image Exposure in Type 2 Diabetes

Type 2 diabetes often requires repeated procedures, including insulin self-injection and self-monitoring of blood glucose. These procedures may cause pain and lead to fear of self-injection and blood glucose testing, which may negatively affect treatment adherence and diabetes self-management. Nature-based visual stimuli may serve as a simple, non-pharmacological distraction method by directing attention away from painful or fear-inducing procedures. This randomized controlled trial evaluated the effects of nature image exposure on pain, fear of self-injection, and fear of blood glucose testing in adults with type 2 diabetes. A total of 64 participants were randomly assigned to either the intervention group (n=32) or the control group (n=32). Participants in the intervention group viewed a standardized nature image displayed on a fixed wall-mounted screen for 3-5 minutes immediately before insulin self-injection and self-monitoring of blood glucose. Participants in the control group received standard care without nature image exposure. Outcomes were assessed using the Diabetes Fear of Injecting and Self-Testing Questionnaire and the Visual Analog Scale.

Preoperative Oral Carbohydrate Loading in Patients With Type 2 Diabetes Undergoing Gastrointestinal Surgery

This study is a single-center randomized controlled trial in adults with type 2 diabetes who are scheduled for elective gastrointestinal surgery. The study aims to find out whether drinking a carbohydrate-containing clear liquid before surgery can reduce early postoperative insulin resistance and improve blood glucose stability without increasing the risk of high or low blood glucose. Participants will be randomly assigned in a 1:1:1 ratio to one of three groups. The first group will receive standard enhanced recovery after surgery (ERAS) fasting and clear-fluid management without a carbohydrate-containing drink. The second group will drink 400 mL of a 12.5% maltodextrin carbohydrate solution, providing about 50 g of carbohydrate, approximately 2 hours before anesthesia. The third group will receive 500 mL of 10% glucose solution intravenously over approximately 2 hours before anesthesia. The intravenous glucose group is included mainly to help explore whether the route of carbohydrate administration affects the metabolic response. All participants will receive standard perioperative care. Blood glucose will be monitored during the perioperative period, including continuous glucose monitoring when available, with point-of-care blood glucose testing used to confirm clinically important high or low glucose readings and to guide treatment when necessary. The primary outcome is insulin resistance on the first day after surgery, measured using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), which is calculated from fasting blood glucose and fasting insulin concentrations. Secondary outcomes include perioperative glucose levels and glucose variability, time spent within, above, and below the target glucose range, insulin and C-peptide levels, postoperative nausea and vomiting, patient comfort, postoperative recovery, hospital stay, postoperative complications, and safety events such as hypoglycemia, severe hyperglycemia, reflux, or aspiration. The main comparison of interest is between the oral carbohydrate group and the standard ERAS group. The intravenous glucose group will be analyzed mainly as a mechanistic exploratory group.

Mulligan Mobilization With Movement Versus Conventional Physiotherapy on Ankle Range of Motion, Mobility, Pain, and Quality of Life in Patients With Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus (T2DM) is a major global health concern associated with chronic hyperglycemia, oxidative stress, and accumulation of advanced glycation end-products, which impair connective tissue function and commonly restrict ankle (tibiotalar) mobility. Reduced ankle range of motion, neuropathic pain, and gait instability significantly impair daily activities and quality of life in this population, and reduced ankle mobility is further associated with increased risk of diabetic foot ulceration. Conventional physiotherapy is widely used to address these impairments through exercise, stretching, and strengthening, but may not fully resolve mechanical joint restrictions. Mulligan's Mobilization with Movement (MWM) is a manual therapy technique in which a sustained glide is applied to the ankle during active weight-bearing movement, correcting positional faults and improving dorsiflexion range of motion. While MWM has shown benefit in non-diabetic ankle conditions, its effectiveness relative to conventional physiotherapy in patients with T2DM remains unclear. This study is a randomized controlled trial comparing the effects of Mulligan Mobilization with Movement (Group A) versus conventional physiotherapy (Group B) on pain intensity, ankle range of motion, functional mobility, and quality of life in adults aged 50-70 years with Type 2 Diabetes Mellitus of more than 5 years' duration. A total of 56 participants will be recruited using non-probability purposive sampling and randomly allocated by coin-toss method into two equal groups of 28. Both groups will receive baseline treatment (hot pack application and gentle active ankle movement) followed by their assigned protocol - Group A receiving MWM (sustained anteroposterior/posteroanterior glide to the distal tibia or fibula during active dorsiflexion or plantarflexion, 3 sets of 10 repetitions) and Group B receiving conventional physiotherapy (active/passive range-of-motion exercises, calf raises, and calf/Achilles stretching) - three sessions per week for six weeks. Outcomes will be assessed at baseline and following the six-week intervention period. Primary outcome measures include pain intensity (Numeric Pain Rating Scale), ankle range of motion (goniometer), functional mobility (Timed Up and Go test), and quality of life (SF-12 Health Survey). Data will be analyzed using IBM SPSS Statistics version 27, with normality assessed via the Shapiro-Wilk test and within- and between-group comparisons made using parametric or non-parametric tests as appropriate. This trial is expected to generate direct comparative evidence on whether Mulligan Mobilization with Movement offers superior outcomes to conventional physiotherapy for ankle-related impairments in patients with T2DM, helping physiotherapists select more targeted, evidence-based rehabilitation protocols for this population.

Community-based, eHealth Supported Type 2 Diabetes Care by Lay Village Health Workers in Rural Lesotho

This cluster-randomized intervention is embedded in the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID AO\_2022-00058, clinicaltrials.gov ID NCT05596773, Lesotho NH-REC ID 210-2022), a platform for the investigation of chronic diseases and their management in rural Lesotho that is maintained by local lay village health workers (VHWs). The overall objective of the ComBaCaL cohort study and nested TwiCs is to assess the impact of eHealthsupported, lay-led chronic disease control measures in rural Lesotho. In this DM TwiC, the effect, safety and feasibility of a community-based DM care package (which includes the offer of first-line oral antidiabetic and lipid-lowering treatment for uncomplicated DM by lay VHWs in comparison to facility-based care after community-based screening and diagnosis) will be evaluated.