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About This Study

The planned study is a Randomized Controlled Monocentric Trial, which will provide evidence on whether early angiography in percutaneous transluminal angioplasty (PTA) readiness ("immediate" treatment, within 48h) has advantages over the "standard of care", i.e., an elective procedure ("elective PTA") for the treatment of diabetic foot ulcer (DFU). The primary study endpoint is to investigate the impact of the "early PTA" within 48 hours on wound-healing assessed by wound area changes after PTA using a 3D-camera with artificial intelligence (AI)-based wound-analysis-system. The secondary endpoint is the effect of early PTA on the combined occurrence of major adverse limb (MALE) and cardiac events (MACE) over 12 months post-angioplasty using time-to-event analysis. Data will be collected at baseline, 24 hours, 1, 2, 3, 6, and 12 months after PTA. Diabetic kidney disease, distal symmetric polyneuropathy, retinopathy, cardiomyopathy, laboratory analyses, clinical scores, AI-based fundus photography, echocardiography, duplex sonography, and pulse oscillography will be assessed. Explanatory variables for wound healing are wound microbiome changes using whole-genome sequencing and oxygen saturation of the wound environment measured using near-infrared spectroscopy. Altered microbiome composition in ulcers can lead to severe local and systemic infections and complications, including major amputations. Nevertheless, the specific significance of the wound microbiome composition in chronic ischaemic ulcers in type 2 diabetes and the impact of PTA on the wound microbiome in type 2 diabetes is unclear. The exact timing for treating peripheral arterial disease (PAD) by revascularization in DFU after initial diagnosis is unknown and has yet to be fully understood.

Design

Interventions / Regimen

• Procedure: Percutaneous transluminal angioplasty — Percutaneous transluminal angioplasty of the leg

Primary Outcomes

• Effect of PTA within 48h on changes of the wound area (Wound area difference from baseline to last visit)

About This Study

The goal of this clinical trial is to evaluate whether remote ischemic conditioning (RIC) is a safe and effective treatment for non-proliferative diabetic retinopathy (NPDR) in adults aged 40-80 years with type 2 diabetes. The study aims to address the limitations of current treatments for NPDR by using RIC, a technique involving repeated cycles of ischemia and hypoxia stimulation to activate protective mechanisms against retinal damage. The main questions it aims to answer are: Does RIC improve the Diabetic Retinopathy Severity Score (DRSS) after one year of treatment? Does RIC reduce the incidence of vision-threatening proliferative diabetic retinopathy (PDR)? What are the changes in retinal neurovascular unit parameters, visual acuity, and retinal oxygen saturation after RIC treatment? Participants will: Undergo RIC therapy using a specialized device on both upper limbs (or a placebo intervention for the control group) for 1 year. Complete 5 cycles of RIC or placebo treatment twice daily, 5 days per week. Receive routine care for diabetic retinopathy as per clinical guidelines. Key outcome measures: Primary outcome: Change in DRSS from baseline after one year. Secondary outcomes: Incidence of PDR, changes in visual acuity, retinal neurovascular unit measures, retinal oxygen saturation, and serum biomarkers (e.g., VEGF, CRP, IL-6). This randomized, double-blind, placebo-controlled trial aims to recruit 68 participants to ensure 60 complete the study, accounting for a 13% dropout rate. The findings are expected to provide insights into RIC as a novel intervention for NPDR, reducing blindness risk and supporting future large-scale trials.

Design

Interventions / Regimen

• Device: Remote Ischemic Conditioning Device — Participants in this group will use a remote ischemic conditioning device that applies five cycles of 5-minute inflation at 200 mmHg followed by 5-minute deflation on both arms, twice daily, for at least five days per week over one year. The device is designed to enhance retinal oxygenation and reduce hypoxia-related damage.
• Device: Sham Remote Ischemic Conditioning Device — Participants in this group will use the same remote ischemic conditioning device set to an inflation pressure of 60 mmHg to simulate the treatment. This placebo intervention follows the same timing and cycle frequency as the active intervention group.

Primary Outcomes

• Change in Diabetic Retinopathy Severity Score (DRSS) (Baseline and 1 year after intervention)

About This Study

A cohort study on patients with type 2 diabetes to investigate possible biomarkers as predictors of chronic heart failure.

Design

Primary Outcomes

• Chronic Heart Failure (During 5 year follow up)

About This Study

The overall aim of the study is to observe the change of long-term metabolic control in patients with type 2 diabetes who have access to a digital intervention tool as compared with randomized controls during one year. The tool is based on self-affirmation theory and has large emphasis on self-reflection to enable sustainable lifestyle changes. Users get access to expert-written information about relevant health topics and interact with an LLM to promote reflection on the information.

Design

Interventions / Regimen

• Behavioral: Lifestyle tool — Regular use of the digital Lifestyle tool

Primary Outcomes

• Change of long-term blood glucose concentration measured as glycated hemoglobin at 1 year (1 year)

About This Study

This multicenter randomized controlled trial will evaluate whether an AI-assisted intensive lifestyle intervention can improve weight and glycemic management in adults with obesity and newly diagnosed type 2 diabetes, compared with tirzepatide treatment and standard lifestyle management. Eligible participants will be adults aged 18 to 65 years with a body mass index of 28 to less than 40 kg/m² and newly diagnosed type 2 diabetes who have not used glucose-lowering medications in the past 3 months. Participants will be randomly assigned to one of three groups: an AI-assisted intensive lifestyle intervention group, a tirzepatide treatment group, or a standard lifestyle management control group. The intervention period will last 52 weeks, followed by a 12-week post-intervention follow-up period. The main outcome is the percentage change in body weight at week 52. The study will also assess glycemic control, body composition, continuous glucose monitoring metrics, safety, and other metabolic outcomes.

Design

Interventions / Regimen

• Behavioral: AI-Assisted Intensive Lifestyle Intervention — An intensive lifestyle intervention supported by an AI-based platform and nutritionist follow-up, including individualized dietary guidance, lifestyle behavior support, and weight management counseling.
• Drug: Tirzepatide — Tirzepatide will be administered by subcutaneous injection once weekly according to the protocol-defined dose titration and tolerability assessment.
• Behavioral: Standard Lifestyle Management — Standardized lifestyle management and health education, including general dietary, physical activity, and weight management advice according to the study protocol.

Primary Outcomes

• Percent Change in Body Weight From Baseline to Week 52 (Baseline to Week 52)

About This Study

This prospective observational study aims to evaluate ocular structural and microvascular changes in adults with obesity who are receiving semaglutide or tirzepatide as part of routine clinical care. Participants with and without type 2 diabetes mellitus will be included. Participants will undergo ophthalmologic examinations at baseline and during follow-up. Changes in optic nerve head parameters, retinal thickness, retinal and choroidal microvascular parameters, and choroidal thickness will be assessed using optical coherence tomography (OCT), optical coherence tomography angiography (OCT-A), and other routine ophthalmologic examination methods. The study will compare ocular measurements obtained at baseline and during follow-up to investigate changes associated with semaglutide or tirzepatide treatment over a period of up to 18 months.

Design

Interventions / Regimen

• Drug: Semaglutide — Semaglutide is prescribed as part of routine clinical care. Treatment is not assigned by the study protocol. Ocular structural and vascular parameters are evaluated before treatment and during follow-up.
• Drug: Tirzepatide — Tirzepatide is prescribed as part of routine clinical care. Treatment is not assigned by the study protocol. Ocular structural and vascular parameters are evaluated before treatment and during follow-up.

Primary Outcomes

• Change in Retinal Nerve Fiber Layer Thickness (Baseline to up to 18 months)
• Change in Retinal Thickness (Baseline to up to 18 months)
• Change in Superficial Retinal Vessel Density (Baseline to 18 months)
• Change in Deep Retinal Vessel Density (Baseline to 18 months)
• Change in Foveal Avascular Zone Area (Baseline to 18 months)
• Change in Choriocapillaris Flow Deficit Percentage (Baseline to 18 months)

About This Study

This behavioral intervention study aims to assess physical activity levels and sedentary behavior among individuals with diabetes. It will compare the effectiveness of standard interventions against informational sessions on the benefits of physical activity for achieving changes in behavior and improving quality of life while reducing reliance on healthcare services. Participants will be divided into 3 groups: one receiving standard care from the diabetology service; one attending three theoretical motor counseling sessions; another engaging in three theoretical motor counseling sessions plus practical counseling supervised by kinesiologist. The primary objective is to evaluate physical activity levels at 6 and 12 months post-intervention. Secondary objectives include assessing sedentary time, health status, anthropometric measurements, blood pressure, barriers to engaging in physical activity, motivation levels, dietary habits, readiness for lifestyle changes, perceived quality of life, and functional capacities.

Design

Interventions / Regimen

• Behavioral: Theoretical Counseling on Physical Activity (TCPA) — Participant wil be involved in: * Routine assessments: Anthropometric (weight, height, waist circumference) and hematobiochemical parameters (e.g., glycemic and lipid profiles), and systolic and diastolic blood pressure. * General information + administration of the IPAQ, PACE, Barriers, Mediterranean Diet, and Quality of Life questionnaires. * Body Composition Assessment: BMI, fat mass (FM), fat free mass (FFM), muscle mass, total body water (TBW) and basal metabolism rate (BMR). * Non-diagnostic assessment of functional abilities: submaximal tests of strength, muscular endurance, and flexibility. * Only 3 sessions (1 per month) of TCPA: the Kinesiologist will inform the patient about the guidelines and the various types of PA, as well as their dose-dependent effects.
• Behavioral: Standard Care + Theoretical Counseling on Physical Activity (TCPA) + Practical Counseling on Physical Activity (PCPA) — Participant wil be involved in: * Routine assessments: Anthropometric (weight, height, waist circumference) and hematobiochemical parameters (e.g., glycemic and lipid profiles), and systolic and diastolic blood pressure. * General information + administration of the IPAQ, PACE, Barriers, Mediterranean Diet, and Quality of Life questionnaires. * Body Composition Assessment: BMI, fat mass (FM), fat free mass (FFM), muscle mass, total body water (TBW) and basal metabolism rate (BMR). * Non-diagnostic assessment of functional abilities: submaximal tests of strength, muscular endurance, and flexibility. * Only 3 sessions (1 per month) of TCPA: the Kinesiologist will inform the patient about the guidelines and the various types of PA, as well as their dose-dependent effects. * PCPA: supervised mixed physical activity program (cardiovascular + resistance) lasting 3 months, with 2 sessions per week.

Primary Outcomes

• Total weekly physical activity time (At the time of enrollment and follow-up (6 and 12 months).)

About This Study

To examine the effects of twice daily whey protein consumption on blood glucose and insulin in pre-diabetic and diabetic individuals

Design

Interventions / Regimen

• Dietary Supplement: Whey Protein Isolate Crossover — This crossover intervention includes 1 week of whey protein isolate supplementation and 1 week of placebo supplementation.
• Dietary Supplement: Placebo — 1 week of Non-whey protein Placebo supplement

Primary Outcomes

• Whole body protein turnover (7 days)
• Oral Glucose Tolerance Test (7 days)
• Blood glucose (7 days)

About This Study

Individuals with lactase non-persistence (LNP; determined by a functional variant in the LCT gene \[rs4988235, GG genotype\]) are susceptible to lactose intolerance in adulthood due to deficiency of lactase, the enzyme which digests milk lactose sugars. However, many LNP individuals still drink ≥1 cup of milk daily. Recent analysis in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) found that consumption of 1 serving (cup) of milk/day was associated with \~30% lower risk of type 2 diabetes among LNP individuals, but not among individuals with lactase persistence (LP). This beneficial effect might be partially explained by favorable alterations in gut microbiota and related metabolites associated with higher milk consumption among LNP individuals. Based on these observational study findings, the investigator team proposes to conduct a randomized, controlled trial of lactose-containing vs. lactose-free milk in LNP individuals with pre-diabetes, to comprehensively investigate the effects of milk intake on the gut microbiome and glycemic outcomes.

Design

Interventions / Regimen

• Dietary Supplement: Lactose-Containing Milk — Participants will be asked to drink regular milk (1% or 2%) for 12 weeks as follows: * Weeks 1-4: ½ cup milk per day * Weeks 5-8: 1 cup milk per day * Weeks 9-12: 2 cups milk per day Participants will continue drinking 2 cups milk/day for 2 weeks after the 12-week follow-up visit.
• Dietary Supplement: Lactose-Free Milk — Participants will be asked to drink 1% or 2% lactose-free milk for 12 weeks as follows: * Weeks 1-4: ½ cup milk per day * Weeks 5-8: 1 cup milk per day * Weeks 9-12: 2 cups milk per day Participants will continue drinking 2 cups milk/day for 2 weeks after the 12-week follow-up visit.

Primary Outcomes

• Gastrointestinal symptoms (Daily From Screening visit to Week 12)
• Change in Expired Breath Hydrogen (From Baseline to Week 12)
• Change in gut microbiome features - Relative Abundance of Species (From Baseline to Week 12)
• Change in gut microbiome features - Functional Pathway Relative Abundance (From Baseline to Week 12)
• Change in gut microbiome features - Metabolomics (From Baseline to Week 12)
• Change in glycemic outcomes - Fasting glucose (From Baseline to Week 12)
• Change in glycemic outcomes - Hemoglobin A1c (HbA1c) (From Baseline to Week 12)
• Change in glycemic outcomes - Continuous Glucose Monitoring (CGM) mean glucose (From Screening visit to Week 14 visit)

About This Study

The goal of this clinical trial is to learn if propolis administration works to change the level of Low Density Lipoprotein (LDL) and High Density Lipoprotein cholesterol (HDL) in diabetic type 2 patients. The main questions it aims to answer are: \- Is giving 1 drops/ 10kg/ times, twice daily for 8 weeks will change the level of LDL and HDL level in diabetic type 2 patients compared to placebo? Researchers will compare propolis to a placebo (a look-alike substance that contains no drug) to see if propolis works to change LDL and HDL cholesterol level. Participants will: * Take propolis or a placebo, 2 times daily with given dose (1 drops/10 kg/times) every day for 2 months * Visit the sub-district health centre once every 2 weeks for checkups * Get their blood checked before and after intervention

Design

Interventions / Regimen

• Drug: Propolis drops — The intervention given is propolis drops that are approved by Indonesian Food and Drug Authority
• Other: Placebo — The given placebo are look-alike substance with no effect

Primary Outcomes

• Low Density Lipoprotein (8 weeks)
• High Density Lipoprotein (8 weeks)

About This Study

The purpose of this study is to identify the risk of non-alcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes in clinical practice and to evaluate the clinical usefulness of Dapagliflozin/Pioglitazone combination therapy

Design

Primary Outcomes

• Percentage of subjects who correspond to high risk score (≥8) by evaluating simple NAFLD score (Baseline (visit 1))

About This Study

The goal of this clinical trial is to increase Type 2 Diabetes Mellitus knowledge and awareness among patients who present to the Emergency Department with hyperglycemia. The main questions it aims to answer are: * How do patients view their risk of developing type 2 diabetes based on their demographics and behaviors? * Does giving patient education increase patient knowledge, leading to healthier behaviors? Researchers will assess if the educational intervention increases diabetes knowledge and positive health behaviors among Emergency Department hyperglycemic patients. Participants will: * Receive the educational packet (intervention) alongside standard Emergency Care. * Take pre-survey at time of Emergency Department visit and post- survey two weeks later.

Design

Interventions / Regimen

• Behavioral: Educational Intervention — Utilizing the Health Belief model, educational materials detailing diabetes risk factors to address perceived susceptibility, diabetes severity and complications to address perceived severity, and PCP follow-up information and medication assistance programs to address perceived barriers will be provided.

Primary Outcomes

• Diabetes Knowledge (Initial Emergency Department presentation to follow-up survey (2 weeks later))