Clinical Research Directory

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.

Monitoring of the Sympathetic/Vagal Balance Through Multiparametric Analysis of Heart Rate Variability (HRV)

The autonomic nervous system (ANS) plays a crucial role in cardiovascular regulation by modulating heart rate in response to endogenous and environmental stimuli. Heart rate variability (HRV) analysis has been widely used as a non-invasive tool to assess autonomic function and the balance between sympathetic and parasympathetic activity. Although the physiological interpretation of some HRV parameters remains debated-particularly the low-frequency (LF) spectral component as an index of sympathetic activation-HRV remains an important method for evaluating autonomic cardiovascular control. Reduced HRV has been associated with adverse outcomes in several pathological conditions and physiologically declines with aging, mainly due to progressive neuronal loss at central and spinal levels. Among conditions characterized by autonomic dysfunction, cardiovascular autonomic neuropathy (CAN) represents a common complication of diabetes mellitus (DM) and metabolic syndrome. CAN, defined as impairment of autonomic control of the cardiovascular system, develops early in the disease course and is associated with increased mortality and a higher risk of cardiovascular and renal complications. Sodium-glucose cotransporter 2 inhibitors (SGLT2i), initially developed as glucose-lowering agents, have demonstrated significant cardiovascular and renal protective effects beyond glycemic control. Growing evidence suggests that these drugs exert sympathoinhibitory effects that may be beneficial not only in diabetic patients but also in conditions characterized by sympathetic overactivity. Preclinical and clinical studies have shown that SGLT2i influence autonomic regulation, including sympathetic control of renal function, with reported improvements in 24-hour blood pressure regulation and HRV parameters. Large randomized trials have further confirmed the cardioprotective effects of SGLT2i therapy. Studies such as EMBODY, EMPEROR-Reduced, and EMPEROR-Preserved have demonstrated improvements in HRV indices and significant reductions in cardiovascular death and hospitalization for heart failure, irrespective of diabetic status. Despite these findings, the mechanisms underlying these benefits remain incompletely understood. While reduced sympathetic activity has been proposed as a key mechanism, emerging evidence suggests that SGLT2i may also enhance vagal modulation. Therefore, the present study aims to investigate, in a larger population, the effects of SGLT2i therapy on sympathovagal balance using both spectral HRV parameters and additional indices, including the parasympathetic nervous system index (PNSi), sympathetic nervous system index (SNSi), and the Baevsky Stress Index.

EffectiVenEss of a Rehabilitation Treatment With Nordic Walking in obEse or oveRweight Patients

Nordic Walking (NW) is a biomechanically correct walking technique that originated in Finland in the 1930s as an off-season training method for cross-country skiers. In the NW, the use of special sticks is combined with "conventional" walking: this involves a greater caloric expenditure, with an energy consumption higher by 20-30% compared to walking without sticks, and also toning of the upper part of the body, in particular triceps, shoulders and back, and the involvement of about 90% of the body's muscles, while maintaining a reduced load on ligaments and joints (Baek \& Ha, 2021). The NW acts simultaneously and effectively on different components of fitness: coordination, endurance, strength, and mobility. It does not require sudden accelerations and is based on a technique that is easy to learn (with the help of an instructor), especially as regards maintaining correct posture. Finally, in addition to the cardiovascular benefits, NW has also been shown to effectively reduce the risk of falls in the elderly. The study is a single-center, randomized controlled trial (RCT), with a three-parallel-arm design, open-label. The primary objective is to evaluate the efficacy (in terms of cardiovascular performance), safety, and adherence (in terms of dropout rate) to the exercise prescription after 6 and 12 months follow-up of a 3-month NW intervention compared with standard rehabilitation training (SR, 3 months) in obese/overweight diabetic patients with cardiovascular (CV) complications. The study will enroll in parallel a control group that can access only generic cardiological counseling with a prescription for unsupervised home exercise.

Study Evaluating the Safety and Feasibility of Endoscopic Duodenal Injections of Autologous Mesenchymal Stem Cells

Type 2 Diabetes Mellitus (T2DM) pathogenesis increasingly involves "diabetic duodenopathy," characterized by proximal intestinal immune and epithelial dysregulation. This study investigates the endoscopic delivery of adipose-derived mesenchymal stem cells (ADMSCs) into the duodenum and proximal jejunum as a disease-modifying therapy. By leveraging the paracrine immunomodulatory and regenerative effects of ADMSCs in close proximity to the pancreatico-enteroendocrine system, this targeted approach aims to restore insulin sensitivity and $\\beta$-cell function while minimizing systemic exposure. The clinical safety and feasibility of this novel delivery route remain to be established.

PATHS-T2D: A Recall-by-Genotype Study of Physiologic and Pharmacologic Responses

This research study aims to learn about how the body responds to food through different genetic pathways and how these responses may change during a short course of orforglipron. Orforglipron is an oral glucagon-like peptide-1 (GLP-1) receptor agonist that was approved by the U.S. Food and Drug Administration (FDA) on April 1, 2026, for long-term weight management. In longer studies, it has helped people lose weight and improve blood sugar, blood pressure, and cholesterol. By taking part, participants will receive detailed metabolic testing and may receive study results with additional information about their blood sugar and metabolic health.

Metformin in Elderly Patients With Type 2 Diabetes and Muscle Strength, Muscle Mass, and Physical Function: Positive or Negative Correlation?

With the accelerating aging process in China, sarcopenia has drawn increasing attention. Sarcopenia is an age-related geriatric syndrome characterized by reductions in muscle mass, muscle strength, and/or physical function. Sarcopenia has a high prevalence, often insidious onset, and broad impacts on physiological functions. According to the 2019 report from the Asian Working Group for Sarcopenia (AWGS), sarcopenia prevalence among elderly Asians ranged from 5.5% to 25.7%, with males exhibiting higher rates (5.1% to 21.0%) than females (4.1% to 16.3%). Particularly among patients with diabetes, sarcopenia incidence was significantly elevated, with a prevalence of 14.8% reported in Chinese diabetic populations. Sarcopenia exerts numerous adverse effects. Sarcopenia is strongly associated with adverse cardiovascular events and increased mortality. Sarcopenia is linked to cancer and significantly elevates the risk of various postoperative complications in patients with gastrointestinal malignancies, including dysphagia, cognitive impairment, fractures, falls, hospitalization, and all-cause mortality. Sarcopenia and diabetes frequently coexist within the same individual, leading to multiple adverse outcomes. Sarcopenia results in declining in function flexibility and responsiveness in diabetic patients, causing gait alterations and impaired balance, limiting daily activities, and is closely linked to risks of falls, fractures, depression, frailty, and mortality. Thus, it is critically important to treat sarcopenia alongside diabetes and avoid detrimental effects of hypoglycemic drugs on muscle. Metformin lowers blood glucose by increasing muscle glucose uptake, inhibiting hepatic glucose output and gluconeogenesis, and promoting glucose excretion into the intestinal lumen; it also reduces the risk of diabetic cardiovascular disease, diabetic retinopathy, nephropathy, and neuropathy. There remains controversy in current studies regarding metformin's impact on sarcopenia. Some studies indicate that metformin may have potential beneficial effects on grip strength, skeletal muscle mass, and gait speed. Nordklint AK reported that after 18 months of metformin intervention in patients with type 2 diabetes, bone mineral content and density were improved. Qaisar R conducted a 16-week metformin trial on older men, finding improvements in grip strength and gait speed with statistical significance (P \< 0.05). Klimova AV found that a 6-month metformin intervention improved physical function in patients. Lyu Q's murine study demonstrated that 5 months of metformin treatment conferred benefits and recovery effects on the gastrocnemius muscle in sarcopenia models. Conversely, some studies indicate no impact of metformin on muscle mass, grip strength, or gait speed. Qaisar R reported no improvement in body composition or gait speed after 4 months of metformin use. Laksmi PW found no significant difference in grip strength between groups after a 16-week metformin intervention. Koshizaka M reported that after 24 weeks of intervention with ipragliflozin or metformin in patients with type 2 diabetes, metformin had no significant effect on muscle mass. Previous studies have also elucidated mechanisms underlying metformin's effects on muscle. According to Kang MJ, metformin induced myostatin expression in skeletal muscle cells via the Adenosine5'-monophosphate-activated protein kinase (AMPK)-FoxO3a-HDAC6 pathway, thereby impairing muscle function. Other studies found that metformin reduced expression of mTORC1-related genes in muscles of elderly individuals with impaired glucose tolerance, potentially leading to decreased muscle protein synthesis or increased autophagy. Therefore, this study enrolled elderly patients with type 2 diabetes and employed a cross-sectional design with propensity score matching to elucidate the association between metformin and muscle strength, muscle mass, and physical function, providing evidence for rational clinical use of hypoglycemic drugs.

Safety, Tolerability and Efficacy of Semaglutide Depot in Subjects With Type-2 Diabetes Mellitus

Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is an approved and well-established therapy for type 2 diabetes mellitus (T2DM), providing both robust glycemic control and weight reduction. Semaglutide Depot, is a long-acting formulation of semaglutide, designed for once every four weeks administration, intended to reduce treatment burden, and improve adherence supporting sustained glycemic control over time. This Phase I/Ila dose escalation study design to evaluate the safety, tolerability, pharmacokinetics and efficacy of Semaglutide Depot in adults with T2DM.

Digital Intervention Promoting Physical Activity Among Obese People (DIPPAO)

Overweight and obesity are today considered among the most important health risks facing humanity with more than one in two adults overweight or obese in western countries. In addition, Type 2 diabetes mellitus (T2DM) is a common comorbidity associated with overweight and obesity and counts for 5% of the French population under 65 years of age and 15% in people over 65 years old. Despite the accumulation of scientific evidence supporting the benefits of physical activity, obese and diabetic people remain insufficiently active and current programs struggle to engage and sustain physical activity of patients over long periods of time. It is therefore urgent to develop interventions that can effectively change individuals' behavior. In this context, "e-health" interventions and gamification appear to be a particularly promising avenue to improve physical activity and reduce attrition rates of current programs. This clinical trial aim to test the effectiveness of a digital intervention based on gamification and teamwork in comparison to a supervised physical activity program. The investigators hypothesized that the intervention will be efficient by the development of a self-determined motivation through the process of gamification on the one hand. On the other hand, through the in-group collaboration with other people who share the same stigmatized criteria that will help participants to overcome weight stigmas, acting generally as physical activity barriers.

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?

Nutrition Intervention Optimization to Better Utilize Resources and Support Health

Not having enough food for each person in a household, also called food insecurity, makes it hard to eat a nutritious diet, maintain a healthy weight, and manage diabetes risk. Food banks and pantries provide direct food assistance that can mitigate food insecurity among people with lower income, however, people that utilize these organizations face time, resource, and physical constraints that limit their ability to consistently select and cook healthier meals and the organizations face budget constraints that limit their bandwidth for implementing nutrition programs. This research will test four innovative nutrition programs (nutritious prepared meals, medically tailored groceries in the form of meal kits, culinary medicine, motivational text messages) to identify which are the most effective for supporting healthy eating and food security and the most cost effective for organizations to implement, as an effort to reduce diabetes risk, improve diabetes self-management, and diminish health disparities.

Type 2 Diabetes Mellitus and Downhill Aerobic Exercise Training

The purpose of this study is to compare the effects of an 8-week supervised downhill walking training program, prescribed based on the 6-minute walk test, on functional capacity, peripheral muscle strength, and cardiovascular responses in individuals with type 2 diabetes mellitus, as compared to a level walking training program. Participants who agree to take part in the study will be randomly assigned to either the downhill or the level-ground walking group. Both groups will undergo a 6-minute walk test (6MWT) at the beginning of the study, and participants will then undergo an 8-week walking training program-conducted twice a week on a treadmill under the supervision of a physical therapist-in which their walking speed is determined based on their average speed during the 6MWT and gradually increased, with the duration of the sessions also being extended. Participants will do the following: * They will participate in walking training sessions at a center twice a week for 8 weeks, under the supervision of a physical therapist. * Once a week for 8 weeks, they will walk the same distance they walked with their supervisor that week as a homework assignment. * They will come to the facility where they conducted their exercise sessions for evaluations at the beginning of the program and after the 8th week.

Normast3 for Adults With Diabetic Polyneuropathy

The goal of this clinical trial is to find out if a new supplement called Normast® 3 can help reduce nerve pain and improve nerve function in adults with diabetic polyneuropathy (DPN). DPN is a common complication of diabetes that damages nerves, often causing burning, tingling, or stabbing pain, as well as problems with the autonomic nervous system, which controls things like sweating and heart rate. The main questions this study aims to answer are: Does taking Normast® 3 lower daily pain levels after 12 weeks of treatment? Does it improve the function of small nerve fibers and the autonomic nervous system compared with a placebo (a look-alike tablet with no active ingredients)? Study design This is a randomized, double-blind, placebo-controlled clinical trial. This means participants are randomly assigned to receive either Normast® 3 or placebo, and neither participants nor researchers will know who is receiving which treatment until the study ends. Who can take part About 40 adults aged 18 to 80 who have diabetic polyneuropathy affecting both small and large nerve fibers will be enrolled. Participants must have stable diabetes treatment for at least 3 months and be able to take oral medication. People with other nerve diseases, major psychiatric conditions, or serious health problems will not be able to take part. What participants will do Take Normast® 3 or placebo tablets twice a day for 12 weeks while continuing their usual treatments Complete pain and symptom questionnaires Have neurological examinations including quantitative sensory testing, heart and blood pressure tests, the dynamic sweat test, and small skin biopsies to look at intraepidermal nerve fibers Return for follow-up visits at 12 weeks (end of treatment) and 24 weeks (long-term follow-up) Safety and follow-up Researchers will check participants' safety through blood and urine tests and by monitoring any side effects. Participants can stop the study at any time. Where the study takes place This study is being conducted at the Department of Human Neuroscience, Sapienza University of Rome (Italy).

Evaluate the Effect of Remote Exercise Intervention on Blood Glucose Control and Physical Fitness in T2DM Patients

The intervention group received 12 weeks of continuous remote intervention combined with health education. The control group only received 12 weeks of continuous health education, and the content and frequency were the same as those of the management group. Both groups received instruction at the beginning of the intervention. The intervention group was given priority to continuous walking/running combined with aerobic exercise and swimming. Five to seven sessions per week for 45 minutes each session. Acclimatizations were performed at an intensity of 40%-49% reserve oxygen uptake (VO2R) from weeks 1 to 4, and exercise was performed at an intensity of 50%-59% VO2R from weeks 5 to 12. 5 minutes each of preparation and grooming activities (including joint movement and stretching) for each exercise. Combined with incremental load resistance exercise 2-3 times a week, 8 movements, 2-3 groups each time, repeated 8-10 times/group, with a 2-min rest between groups. The heart rate, RPE (12-13, "fairly easy" to "somewhat laborious") and exercise bracelet were used to monitor the intensity and amount of exercise. The exercise intervention was usually delivered 1-2 h after a meal. The daily medical supervision in the process of management implementation was carried out by trained sports managers through the doctor terminal of "exercise assistant" to collect and monitor the data of the study subjects.

Pocket-X Gel Non-surgical Periodontal Therapy

Evaluate from a clinical and microbiological point of view the effect of an adjunctive therapy based on a thermal-gelling device Pocket-X® Gel (Hyaluronic acid, Poloxamer, 2-Phenoxyethanol, Octedine HCL, Water), in the non-surgical treatment of periodontal defects, in a population of patients with T2DM compared to non-diabetic patients. Determine whether periodontal defect healing is clinically and microbiologically different between T2DM patients and non-diabetic patients; whether periodontal treatment and maintenance can lead to improvement of conditions and stability over time also for diabetic conditions.

Effect of Diode Laser, Gudmar and Vinegar in Diabetic Patients During Root Canal Treatment

Methodology Patient with diabetes 2 with informed consent -convenience sampling over a one year period.The tooth isolated with a rubber dam and the correct disinfection procedures will be used. researcher will do the Access preparation Working length -electronic apex locator (Dentsply Propex II) as well as a radiographic approach. After the canals will be obturated using ZOE sealer and gutta percha and post endodontic restoration is done using composite restoration. Patient is kept on follow up for 7days, 15 days, 30 days ,45 days and 60 days Clinical outcome is measure using periapical radiograph (RVG) Pain is measured using visual analog scale to mark the pain intensity. Data will be analysed statistically To enlarge the root canals (ISO size 20 file) A sterile paper point inside the root canal for one minute until the apex of the root canal is reached Using T.E Buffer, samples will be delivered to the School Of Basic Life Sciences, Sharda University. The samples will be subjected to traditional PCR analysis for the detection of Peptostreptococcus spp. in the root canal. Grouping Following instrumentation, 5% NaOCl and 17% EDTA irrigation will be done. Control group (n=15) The final irrigant will be saline Group 1 (n=15) Irrigation using 5% apple cider vinegar done The final irrigant will be saline Group 2 (n=15) Diode laser is used for disinfection in the presence of saline Group 3 (n=15) Gymnema Sylvestre Mother Tincture Q 1000 CH solution is used for disinfection in the presence of saline Group 4 (n=15) Diode laser is used for disinfection in the presence of 5% apple cider vinegar. The final irrigant will be saline Group 5 (n=15) Diode laser is used for disinfection in the presence of Gymnema Sylvestre Mother Tincture Q 1000 CH solution. The final irrigant will be saline After cleaning and shaping, samples will be collected and sent through T.E. Buffer to the School Of Basic Life Sciences, Sharda University. The samples will be subjected to traditional PCR analysis for the detection of Peptostreptococcus spp. in the root canal.

Culturally Tailored Diabetes Education on Self-Management of Adult Hispanic Males With Type 2 Diabetes Mellitus

Diabetes mellitus (DM) is a global public health concern. In the United States, adult Hispanic males are particularly vulnerable to type 2 diabetes mellitus and are more likely to develop complications and subsequently die from it, compared to non-Hispanic White males. Evidence suggests good self-management behaviors can potentially prevent disease-related complications and improve clinical outcomes. The American Diabetes Association and Association of Diabetes Care and Education Specialists have endorsed diabetes self-management education as a necessary component of care for all individuals living with the disease. However, adult Hispanic males with type 2 diabetes mellitus living in the Middle Atlantic Region of the U.S., especially those who are underserved, typically lack access to formal diabetes self-management education (DSME). Further, the majority have never participated in such educational activities. A large body of evidence suggests DSME can effectively improve self-management behaviors in diverse populations around the globe. The purpose of the proposed study is to examine the effect of culturally tailored diabetes education on self-management behaviors of adult Hispanic males, aged 18-64 years, with type 2 diabetes mellitus living in the Middle Atlantic Region of the U.S. This study can shed more light on the effectiveness of community-based, culturally tailored diabetes educational activities in this vulnerable population and guide future efforts towards enhancing self-management.

Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of HL1113-R1 and HL1113-R2 in Healthy Adult Volunteers

This clinical trial is a two-arm, open-label, single-sequence, multiple oral dosings, cross-over design clinical trial to evaluate the safety and pharmacokinetic characteristics of HL1113-R1 and HL1113-R2 in healthy adult volunteers

Clinical Trial to Evaluate the Pharmacokinetics and Safety Between the Single Administration of HL1113 and the Concomitant Administration of HL1113R1 and HL1113R2 for Healthy Subjects in Fasting State

This clinical trial is a randomized, open-label, single oral dose, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the single administration of HL1113 and the concomitant administration of HL1113R1 and HL1113R2 for healthy subjects in fasting state

A Study to Compare the Pharmacokinetics and Safety of the ATB-U101 and ATB-U1011+ATB-U1012 and ATB-1011+ATB-1012 in Healthy Caucasian Participants

The goal of this Phase 1 clinical trial is to compare the pharmacokinetics and safety of a fixed-dose combination tablet (ATB-U101) versus co-administration of its individual components in healthy Caucasian adult volunteers. The main questions it aims to answer are: * Is the Cmax of Olmesartan and Dapagliflozin bioequivalent across the three treatment regimens? * Is the AUClast of Olmesartan and Dapagliflozin bioequivalent across the three treatment regimens? Researchers will compare ATB-U101 (fixed-dose combination, 40 mg/10 mg) against two reference co-administrations - ATB-1011+ATB-1012 (Korean-approved Olmetec + Forxiga) and ATB-U1011+ATB-U1012 (US-approved Benicar + Farxiga) - to see if the 90% confidence intervals of the geometric mean ratios for the primary PK parameters fall within the bioequivalence range of 80.00-125.00%. Participants will: * Be admitted to the clinical trial center three times (Days 1, 8, and 15), each separated by a 7-day washout period * Receive a single oral dose of one assigned treatment per period under fasting conditions (minimum 10 hours) with 240 mL of water, in a randomized crossover sequence * Have blood samples collected at up to 18 timepoints per period (up to 48 hours post-dose) for PK analysis * Undergo safety assessments including vital signs, ECG, physical examination, and laboratory tests throughout the study, with a final follow-up visit around Day 21-24

SGLT-2 Inhibitors in the Treatment of Ascites

The goal of this observational study is to test the efficacy of glyphozines (SGLT-2 inhibitors) in the control of ascites in patients with liver cirrhosis in class A6-B9, according to the Child-Pugh classification, and type 2 diabetes mellitus. The investigators will compare patients belonging to the intervention group (A), who will be given SGLT-2 inhibitors according to diabetology indications in addition to standard medical therapy for 6, with patients of the control group (B), who will, instead, continue with the standard medical therapy for 6 months. Standard medical therapy will include dietary sodium restriction, treatment with diuretics (furosemide and spironolactone), hypoglycemic therapy (metformin, insulin, or both) and other supportive care. The main questions aims of this study are: 1. Compare the efficacy and safety of a therapeutic approach based on the administration of SGLT-2 inhibitors in addition to optimal medical therapy (MRA and loop diuretic) compared to traditional diuretic therapy only, in cirrhotic patients with saline retention and diabetes. 2. Demonstrate better control of the glycemic profile in cirrhotic diabetic patients using SGLT-2 inhibitors.

Artichoke By-products Rich in Hydroxycinnamic Acids and Mediterranean Diet for Type 2 Diabetes Prevention.

The ARTI-UP study evaluates whether daily consumption of a supplement made from artichoke by-products, rich in hydroxycinnamic acids (HCAs), in combination with an energy-restricted Mediterranean diet (erMeDiet), can improve glycaemic control, reduce insulin resistance and contribute to weight loss in subjects with overweight or obesity. In addition, it seeks to understand the biological mechanisms involved using omic techniques and to establish predictive biomarkers that will enable progress towards personalised nutrition strategies.

A Bridging Study of Efsubaglutide Alfa in Healthy Adults in Brazil

This is a Phase I, randomized, double-blind, placebo-controlled, single-dose study in healthy adult participants in Brazil to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of YN-011. Participants will be randomized to receive a single subcutaneous dose of YN-011 1 mg, YN-011 3 mg, or matching placebo. The study includes screening, approximately 2 days of study-site confinement from the day before dosing to 24 hours after dosing, and outpatient follow-up for 4 weeks. Assessments include safety monitoring, PK blood sampling, PD evaluations, and immunogenicity testing.

Investigation of Gastric Emptying by Gastric Ultrasonography in Diabetic Patients Treated With GLP-1 Receptors

Treatment with semaglutide slows down gastric emptying , food remains in the stomach for a longer period of time. This slowing has important implications for anesthesia management. At present, we do not know the optimal duration for discontinuing this medication before surgery and anesthesia to ensure an empty stomach. This is an observational research project, conducted exclusively at the Geneva University Hospitals (HUG). To answer the research question, participation of 38 individuals will be required. The duration of participation for each person is 7 days. To recruit the necessary number of participants, approximately 1.5 years will be needed. This project is being carried out in accordance with Swiss legal requirements and recognized international guidelines. The competent ethics committee has reviewed and approved this project. The project will last 7 day during which the participants will need to come 3 times at the hospital to make gastric ultrasounds. On these days the participants will be asked to have a breakfast between 7 and 8 am including a minimum of bread and/or cereals and/or proteins. After that the participants will be asked to fast for 6 hours for solide food and 2 hours for liquids. If the participants smokes, they must for 12h before the exam. At 2Pm an anesthesiologist will welcome the participant to make the exam at the hospital to evaluate the gastric volume after what the participants will be able to get a small collation and go back home.

Non-invasive Tests for Non-alcoholic Steato-hepatitis

The main objective is to study and validate a new approach for NASH and liver fibrosis diagnosis and personalized follow-up based on monocyte biomarkers and plasma metabolites. The investigators will assess if PLIN2 and RAB14 can be used not only to identify subjects with NASH and advanced fibrosis but also for monitoring the effect of treatment alone or in combination with other metabolic parameters