Clinical Research Directory

Effects of SGLT2 Inhibition on Myocardial Insulin Sensitivity

A Phase III, single-centre, randomized, 2-arm, parallel-group, double blind, placebo-controlled study, consisting of a screening phase (Days -14 to -1), a 4-week double-blind, placebo-controlled treatment phase and a 4-week follow-up phase. Subjects: Type 2 diabetic patients and coronary artery diseases (CAD) not requiring revascularization or underwent percutaneous coronary intervention (PCI) but clinically stable at time of screening visit, with suboptimal glycaemic control (HbA1c 7.0-8.5%) on their current anti-hyperglycaemic regimen Subjects will be randomized in a 1:1 ratio to dapagliflozin or placebo. Subjects will undergo screening assessment in the 14-day period preceding administration of the first dose of study drug on Day 1. The primary Objective is to assess the effect of dapagliflozin on myocardial insulin sensitivity The Secondary Objective is to assess global heart function, and metabolic systemic effects of dapagliflozin, and glycemic control. The study aims to enroll patients with type 2 diabetes with suboptimal glycemic control, and with coronary artery diseases (CAD) not requiring revascularization or underwent percutaneous coronary intervention (PCI) but clinically stable, who have already undergone, under routine cardiological assessment, a positron emission tomography (PET) 13NH3 scan in order to assess the cardiovascular function. Thus, the study aims to assess whether the improvement in cardiac metabolism obtained with dapagliflozin is greater than that obtained with normal clinical practice (according to Standards of Care).

High Protein Effect on Body Composition and Sarcopenia Markers in Older Patients With Type 2 Diabetes Mellitus

This study will investigate the impact of dietary protein intake on progressive muscle loss and functionality (sarcopenia) in older adults with type 2 diabetes mellitus. Sarcopenia is known to have a bidirectional interaction with type 2 diabetes mellitus. Therefore in order to address this bidirectional complication we suggest that an increased intake of dietary protein at 1.5 gr/kg/day (current official recommendation is 0.8 gr/kg/day) could help to treat the sarcopenia, which in turn will help to ameliorate the type 2 diabetes mellitus progression.

SnapDandCGMinType2Diabetes

Study Title: The Effectiveness of an AI-powered Thai food analysis (SnapD) and Continuous Glucose Monitoring on Glycemic Control in Patients with Type 2 Diabetes and Overweight or Obesity: A Randomized Controlled Pilot Study Rationale: Effective dietary management is the cornerstone of treating Type 2 Diabetes (T2DM) and obesity. However, traditional manual food logging is often inaccurate and burdensome. While digital tools and Continuous Glucose Monitoring (CGM) have shown promise internationally, there is a lack of validated AI-powered tools specifically designed for Thai cuisine. This study introduces SnapD, an AI-powered platform (utilizing Gemini 2.5 Flash) designed to recognize Thai food, estimate nutritional values, and integrate with CGM data to provide personalized feedback. The primary goal of this pilot study is to evaluate the efficacy of the SnapD application, both as a standalone tool and in combination with CGM, compared to Standard of Care in improving glycemic control (HbA1c) over 8 weeks. Additionally, the study aims to assess the feasibility, participant adherence, and safety of these digital interventions to inform a future, fully powered randomized controlled trial. Study Design: This is an 8-week, randomized, open-label, parallel-group, superiority pilot study with a 1:1:1 allocation ratio. A total of 45 participants will be enrolled and assigned to one of three arms: 1. Intervention Arm 1: SnapD application + Real-time CGM + Diabetes Self-Management Education and Support (DSMES) 2. Intervention Arm 2: SnapD application standalone + DSMES 3. Control Arm: DSMES alone Inclusion Criteria Highlights: Adults (18-65 years) diagnosed with T2D with BMI \> 23 kg/m² (overweight/obesity) with HbA1c between 6.5% and 9.0% with Must possess a compatible smartphone/tablet Procedures: Baseline (Visit 1): All participants receive 20-30 minutes of DSMES. Intervention groups receive training on SnapD. Arm 1 receives a 15-day CGM sensor.During Study: Intervention arms log meals via SnapD (at least twice daily). Nutritionists conduct bi-weekly follow-up calls to address technical issues and provide support. End-of-Study (Week 8): Assessment of HbA1c, body weight, waist circumference, lipid profile, and patient-reported outcomes (self-care activities and user satisfaction) Primary Outcome: Mean change in HbA1c from baseline to 8 weeks Secondary Outcomes: Changes in Fasting Plasma Glucose (FPG), body weight, waist circumference, and lipid profiles, Diabetes self-management scores (SDSCA questionnaire), User satisfaction with the SnapD application, Incidence of adverse events (hypoglycemia/hyperglycemia). Significance: This study will provide preliminary evidence on the synergistic benefits of AI-driven nutritional feedback and CGM in a Thai-specific context, supporting the development of scalable, culturally adapted digital health technologies for diabetes management.

Behavioral Change Communication for Physical Activity Among Females With Type2 Diabetes Mellitus

The marked discrepancy between predicted and actual prevalence of Type2 diabetes Mellitus (DM) with the actual cases rising earlier than expected, underscore the continuing relevance of tailored awareness and management strategies including physical activity(PA) to combat growing diabetes pandemic. Research is needed to develop effective programs that promote PA among female patients.Design\& Method randomized controlled trial . 86 females 30 -65 years with type 2 DM attended Diabetic Clinic out patient at government tertiary care hospital,Kerala, south India from May to October 2006 including one week pilot study, participant selection, random allocation and intervention. Block randomized to intervention(43) and control(43) groups. Intervention-'Behavioral change communication model, including 30 mints 'PA promotion video',pamphlet and last week recall and report of PA using an interview schedule for 4 consecutive visits. measures- Total PA/day calculated in calorie from METs(metabolic equivalent score) , HbA1C, Total knowledge score, stage of change of behavior, the baseline PA under four domains in Metabolic Equivalent Task Score by interview using IPAQ(International Physiclal Activity Questionnaire) long form, body weight, occupation and source of water. Physical activity recommendations according to Centres for Disease Control and Prevention Atlanta guide lines- • Moderate intensity PA-30 mins./day(4-6.5 MET) for 5 days/week (brisk walk).Subjective assessment of moderate exercise - 1. talk test-One who is on a moderate intensity level should be able to carry on a conversation comfortable while engagement in the activity. 2. Vigorous intensity PA \>6.5METs-Person will not be able to carry out conversation. running, aerobics for 20 mins

Effort During Resistance Training in Type 2 Diabetes

In this study the primary aims are to investigate the effect of resistance exercise training with different degrees of effort on glycemic control and psychological variables in individuals living with type 2 diabetes mellitus. As a secondary aim, investigate adherence and dropout rates and reasons for dropping out and adhering or not to the protocols.

Clinical Study to Assess the Safety, Efficacy and In-Use Tolerability of Herbal-Based Sugar Support Effervescent Tablets in Type-2 Diabetes Mellitus Patients

This is a Proof-of-Science, exploratory, prospective, single-treatment, two-group, clinical safety, efficacy and tolerability study of herbal based Sugar support effervescent tablets on the patients with Type 2 Diabetes Mellitus.

"Effect of Omega-3 Supplementation as Add on Therapy on Glycemic Control and Lipid Profile in Type2 Diabetes Mellitus."

The goal of this clinical trial is to learn if Omega-3 works to control glycemic status, improve lipid profile in Type2 Diabetic patients. It will also learn about the safety of drug Omega-3. The main questions it aims to answer are: Does drug Omega-3 control glycemic status, improve lipid profile in Type2 Diabetic patients? What medical problems do participants have when taking drug Omega-3? Researchers will compare Omega-3 to a placebo(a look-alike substance that contains no drug)to see if Omega-3 works to treat Type 2 Diabetic patients. Participants will take Omega-3 or a placebo twice daily for 12 weeks. Baseline and 12 weeks after FPG, HbA1c,Serum Lipid profile, Omega-3 level will be monitored.

INcreasing the Uptake of DSMES Program and Addressing Social Needs in Low-Income VulneRablE Immigrants

The purpose of this study is to evaluate a multi-level approach to improve diabetes control via access to social service supports and online, culturally-tailored diabetes self-management education and support (DSMES) videos among a community of primarily Chinese and Latino/a immigrants. The study aims to assess patient uptake, provider adoption, and INSPIRE program acceptability, appropriateness, feasibility, fidelity, penetration/reach, and maintenance.

Behavioral Chronotype: Impact on Sleep and Metabolism

The purpose of this study is to examine how the timing of eating changes how the body makes and uses energy (metabolism). This study will also examine if metabolism changes with age.

A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Dulaglutide in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin

The aim of the study is to compare the efficacy and safety of two JY09 doses versus dulaglutide as add-on therapy to metformin in participants with type 2 diabetes mellitus (T2DM)

Diet and Progression of CKD in Patients With Type 2 Diabetes Mellitus

The aim of this study is to investigate the relationship between dietary patterns and the progression of chronic kidney disease (CKD) in patients with type 2 diabetes mellitus.

A Study to Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults: Fed State Study

To Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults after taking the drugs with food (fed state).

A Study to Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults

To Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults

A Study to Assess Effect of Glucocil® on Metabolic Health in Individuals With Prediabetes and Type 2 Diabetes Mellitus.

A randomized, double-blind, placebo-controlled study to assess the effect of Glucocil® on metabolic health in individuals with prediabetes and Type 2 Diabetes Mellitus.

Effects of a Health Intervention on Fear of Hypoglycemia

To examine the effects of a health Education Intervention based on the Behaviour Change Wheel (BCW) theory on fear of hypoglycemia and relevant outcomes of type 2 diabetic patients.

Effect of Henagliflozein on Hepatic Fat Content in Patients With T2DM and NAFLD

This study focuses on the effects of Henagliflozein on hepatic fat content in patients with type 2 diabetes mellitus (DM) and nonalcoholic fatty liver disease (NAFLD). Sponsored by Zhujiang Hospital of Southern Medical University, this study is a multi-center, randomized, controlled clinical trial, aiming at exploring the difference in the reduction of liver fat content in the subjects compared with the control group after 24 weeks of treatment. Subjects from different medical centers diagnosed with T2DM and NAFLD will be randomly assigned to the treatment or control group in a 1:1 ratio, and subsequently initiate the intervention period of 24 weeks. In this trial, patients will be treated with 10 mg of Henagliflozein + metformin and 5 mg of Linagliptin + metformin as control, and the dose of metformin will be customized at 500-1500mg according to their individual blood glucose level. The check-points are set at the 8th, 16th and 24th week of the follow-up after the treatment, and nutritionists are available to provide dietary and exercise guidance.

Nephroprotective Effect of Nicorandil in Type 2 Diabetes Mellitus

This study aims to evaluate the possible nephroprotective effect of nicorandil in patients with type 2 diabetes mellitus .