Clinical Research Directory

Preserving Muscle Mass During Incretin-Induced Weight Loss

Treatment with incretin-based obesity medications leads to clinically meaningful weight loss and reduced cardiometabolic risk. However, the weight lost includes not only adipose tissue but also skeletal muscle, which may impair physical function and metabolic health. Resistance training is an effective strategy to maintain or increase skeletal muscle mass during weight loss, but its effects during treatment with incretin-based obesity medications have not been studied. This study will investigate whether unilateral resistance training during incretin-based receptor agonist treatment can preserve or improve skeletal muscle volume. The study will also examine whether training affects muscle strength and fatigue tolerance, body composition, cardiac structure and function, and molecular profiles in skeletal muscle, adipose tissue and blood. Participants will be women with obesity who are about to start treatment with an incretin-based receptor agonist as part of routine clinical care. During the 13-week intervention, participants will perform supervised unilateral resistance training twice weekly, training one leg while the other leg serves as an internal control. Assessments before treatment start and after 13 weeks include whole-body and cardiac magnetic resonance imaging, blood sampling, skeletal muscle and adipose tissue biopsies, knee-extensor strength and fatigue tests, and questionnaires. An additional intermediate sampling of blood and tissue (week 4-6) will be collected only in participants who consent to an extra visit.

FABP4 Response After Roux-en-Y Gastric Bypass

This retrospective observational cohort study examined serum fatty acid-binding protein 4 (FABP4) dynamics in 28 adults who underwent Roux-en-Y gastric bypass (RYGB), followed at baseline, 3 months, and 6 months. Anthropometric, metabolic, and inflammatory parameters were assessed alongside FABP4, fasting GLP-1, and PYY. Patients were classified as FABP4 responders (decrease from baseline to 6 months) or rebound/non-responders. The study investigated whether FABP4 trajectory after RYGB is associated with the magnitude of weight loss, systemic inflammation, and fasting incretin change.

Predictive Value of Nutritional and Inflammatory Indices for Postoperative Complications After Bariatric Surgery

Bariatric surgery is an effective treatment for severe obesity, but postoperative complications remain an important cause of morbidity. Several nutritional and inflammatory biomarkers derived from routine preoperative blood tests have been proposed as predictors of postoperative outcomes; however, their comparative value in bariatric surgery has not been fully established. This single-center retrospective cohort study will evaluate the ability of preoperative nutritional and inflammatory indices, including the Prognostic Nutritional Index (PNI), Neutrophil-to-Lymphocyte Ratio (NLR), Platelet-to-Lymphocyte Ratio (PLR), Systemic Immune-Inflammation Index (SII), Systemic Inflammation Response Index (SIRI), and C-reactive Protein-to-Albumin Ratio (CAR), to predict 30-day postoperative complications following bariatric surgery. The study aims to identify the most clinically useful biomarker for preoperative risk stratification and optimization of perioperative care.

Digital Follow-Up and Nursing Education in Bariatric Surgery Patients

This randomized controlled experimental study aims to evaluate the effect of a PHP-MySQL database-based digital follow-up system combined with structured nursing education on quality of life, body mass index (BMI), and exercise habits in patients undergoing bariatric surgery. Although bariatric surgery is an effective treatment for morbid obesity, long-term success depends largely on adherence to lifestyle modifications, including regular physical activity and sustained behavioral change. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive structured nursing education along with an 8-week digitally monitored exercise program starting at postoperative month four. The control group will receive standard postoperative care. Outcomes will be assessed using the Moorehead-Ardelt Quality of Life Questionnaire II (MA-II), BMI measurements, and the International Physical Activity Questionnaire (IPAQ). The study aims to provide evidence for integrating digital health technologies and structured nursing interventions into postoperative bariatric care.

Perioperative Respiratory Function in Sleeve Gastrectomy

This retrospective single-center cohort study aims to evaluate the effects of two intraoperative ventilation strategies on perioperative oxygenation and respiratory outcomes in obese patients undergoing laparoscopic sleeve gastrectomy. Patients were managed using standardized anesthetic and ventilatory protocols with volume-controlled ventilation and fixed inspired oxygen fraction (FiO₂ 45%). The study compares conventional ventilation with PEEP 5 cmH₂O versus a protective ventilation strategy consisting of PEEP 8 cmH₂O combined with repeated recruitment maneuvers performed after pneumoperitoneum establishment and before extubation. Perioperative oxygenation is assessed using serial PaO₂/FiO₂ measurements obtained immediately after intubation, after pneumoperitoneum establishment, and after extubation. Secondary outcomes include perioperative arterial blood gas variables, postoperative spirometric parameters, lactate levels, ICU admission, and hospital length of stay. The study aims to determine whether escalation of intraoperative ventilatory support provides incremental respiratory benefit in contemporary bariatric anesthesia practice.

Ultrasound vs Clinical Parameters for Difficult Airway Prediction in Obesity

Obesity is associated with anatomical changes in the upper airway that increase the risk of difficult laryngoscopy and difficult mask ventilation during anesthesia. Conventional airway assessment parameters such as Mallampati score, neck circumference, and STOP-BANG scale are widely used but have limited predictive accuracy in obese patients. Airway ultrasonography has emerged as a promising non-invasive tool for difficult airway prediction; however, ultrasonographic criteria have not yet been standardized. This prospective observational study aims to evaluate the utility of airway ultrasonography in predicting difficult airway in adult obese patients (BMI \>30 kg/m²) scheduled for elective surgery under general anesthesia. Ultrasonographic measurements will include the distance from skin to hyoid bone (DSHB) at the level of the hyoid bone, the anterior neck soft tissue thickness at the thyrohyoid membrane level, and the hyomental distance ratio (HMDR). These parameters will be compared with conventional airway assessment tools and correlated with intraoperative Cormack-Lehane laryngoscopy grade and Han Scale mask ventilation score to determine their predictive value for difficult airway.

The OB-WELL Project, a Randomized Controlled Trial of an Internet-Based Self-Help System for Psychological Support in Obesity

Objective: This study aims to evaluate the feasibility and effectiveness of the OB-WELL program, an internet-based self-help intervention grounded in the principles of Cognitive Behavioral Therapy (CBT) and Brief Strategic Therapy (BST), designed to promote psychological well-being among individuals with obesity from the general Italian population. Methods: A three-arm randomized controlled trial with individual-level random allocation will be conducted to compare two active intervention formats - CBT and BST - with a waiting list (WL) control condition. The intervention will last six weeks and will consist of five online self-help modules followed by one individual synchronous session. Selected psychological outcomes will be assessed at baseline and immediately post-intervention (after 6 weeks). Participants in the experimental groups will also complete follow-up assessments at 3, 6, and 12 months after treatment termination. Expected results and conclusions: Both active interventions are expected to show greater improvements immediately post-treatment compared to the waitlist (WL) condition, and these effects are anticipated to be maintained over time. It is further hypothesized that the BST condition will demonstrate greater stability of psychological outcomes at follow-up compared to CBT.