Weight Loss

Researchers are investigating how a lifestyle program combining a Mediterranean diet, reduced calorie intake, and physical activity might help middle-aged adults aged 30 to 50 with metabolic syndrome lose weight and maintain that weight loss. Metabolic syndrome includes conditions like high blood sugar, high blood pressure, abdominal obesity, and abnormal cholesterol levels, which increase the risk of heart disease, diabetes, and some cancers. This trial seeks to understand whether this multifactorial intervention can improve heart and metabolic health and what social or demographic barriers affect adherence to lifestyle changes. Participants will be randomly assigned to one of two groups. The intervention group will follow an energy-reduced Mediterranean diet with a 25% calorie restriction combined with a physical activity program based on WHO guidelines. This group will attend monthly individual and group sessions for six months aiming to lose 5-10% of their initial weight. The control group will receive usual care with general healthy lifestyle recommendations from primary healthcare providers. After six months of intervention, all participants will be followed for an additional six months to assess weight loss maintenance. During the study, researchers will collect data on participants’ demographics, body measurements, diet, clinical health, and laboratory tests. They will assess the percentage of weight loss at 6 months and weight loss maintenance at 12 months. The study will also evaluate participants’ adherence to the program and identify factors that help or hinder long-term lifestyle changes. The total study participation lasts one year, including a follow-up after the intervention ends.

Researchers are evaluating whether taking tirzepatide before bariatric surgery can improve outcomes for adults with obesity and related health conditions. This Phase 4 study focuses on patients scheduled for sleeve gastrectomy or gastric bypass surgery. The goal is to see if preoperative tirzepatide reduces inflammation and improves weight loss, metabolic health, and surgical recovery compared to patients not using the drug. Participants will be assigned to either a group that receives tirzepatide injections once weekly for three months before surgery or a standard care group that receives dietary and lifestyle education. Those taking tirzepatide will start with a 2.5 mg subcutaneous injection once a week and may have their dose increased following package instructions during monthly clinic visits. All participants will continue with their planned bariatric surgery and follow-up care as usual. Throughout the study, participants will visit the endocrine clinic monthly for drug prescriptions and side effect monitoring. They will keep diaries to track drug use and any side effects. Researchers will measure changes in inflammatory markers such as CRP, IL-6, TNF, leptin, adiponectin, and RAAS from baseline to three months after starting the drug, and RNA sequencing will be performed at surgery. The study will also assess weight loss, metabolic and inflammatory improvements, comorbidity resolution, and 30-day postoperative complications.

This research focuses on patients with obesity and gastroesophageal reflux disease (GERD) who are candidates for bariatric surgery. It evaluates a revisional surgical technique using magnetic assistance to convert from sleeve gastrectomy to Roux-en-Y gastric bypass (RYGB) combined with hiatoplasty. RYGB is considered a strong option for significant weight loss and resolving comorbidities, and this study aims to address long-term GERD issues following previous surgeries. The procedure is performed by an experienced bariatric surgeon using a single-port approach with magnetic tools to assist in various steps. These steps include liver retraction, division of the omentum, hiatal hernia repair, creation of the gastric pouch, and anastomosis construction. Magnetic assistance is also used to close defects and complete the surgery efficiently. The operation includes routine leak testing and measures specific intestinal limb lengths. Participants will undergo this magnetic-assisted surgical procedure and be closely monitored for complications within 30 days, device malfunctions during surgery, and total surgical time. The study includes assessments of surgical outcomes and safety to ensure proper evaluation of this revisional technique. Participant involvement includes preoperative evaluation and postoperative follow-up within the first month to track results and any adverse events.

Researchers are evaluating a six-month virtually delivered dietary education program called PEDALL to prevent overweight and obesity in children and adolescents undergoing maintenance chemotherapy for acute lymphoblastic leukemia (ALL). This study focuses on participants who are healthy weight at baseline and aims to assess the program's effectiveness compared to standard nutrition care. The research also considers key genetic and sociodemographic risk factors that may affect weight gain during ALL treatment. Participants will be randomly assigned to either the PEDALL intervention group or the standard of care group. The PEDALL group receives 26 contact hours of specialized nutrition education and counseling delivered virtually over six months. The standard of care group receives nutrition education according to their institution's usual practices. The intervention targets English and Spanish-speaking families and starts within the first month of the maintenance phase of ALL therapy. During the study, researchers will monitor participants for weight changes and evaluate the development of overweight or obesity over a 3.5-year period. Assessments include tracking body mass index (BMI) and collecting demographic and genetic information to understand factors influencing intervention success. The goal is to improve weight maintenance during therapy, potentially reducing treatment-related toxicities and long-term nutrition-related health issues in ALL survivors.

Type 2 diabetes and obesity are complex diseases influenced by interactions between genes and the environment. This research aims to better understand how different physical traits affect gene activity in tissues involved in glucose and fat metabolism. The study focuses on the link between obesity and diabetes, sometimes called "diabesity," by examining genetic factors and biological pathways in humans and animal models. Participants who require abdominal surgery, such as bariatric surgery or gallbladder removal, will provide biological tissue samples. The study includes people with varying body mass indexes (BMI) and glucose levels, with groups ranging from severely obese with diabetes to lean individuals without diabetes. Researchers will use advanced genetic and bioinformatics techniques to analyze these samples and explore gene expression patterns. During the study, participants will be assessed before surgery, and tissue samples will be collected during the procedures. Researchers will study how physical and metabolic characteristics influence gene behavior related to diabetes and obesity. The main outcome is to analyze gene expression in tissues involved in glucose metabolism at the start of the study. The research involves participants aged 18 to 65 and monitors their biological data to improve understanding of these intertwined conditions.

Cervical cancer is the fourth most common cancer in women worldwide and often leads to serious nutritional problems, including cancer-related malnutrition and cachexia. About 31% of patients experience these issues, which contribute significantly to mortality. The disease and its treatment, especially concurrent chemoradiotherapy (CCRT), worsen muscle and fat loss through tumor factors and inflammation. This weight loss during CCRT is linked to increased risk of death. Researchers are studying nanocrystalline megestrol acetate (MA), a drug that may help by stimulating appetite and reducing inflammation. This nanocrystalline form has better absorption and faster effects than traditional MA. The trial compares nanocrystalline MA (625 mg daily) combined with CCRT versus CCRT alone in patients with locally advanced cervical cancer. Treatment lasts up to 8 weeks or until the disease progresses. Participants will be monitored for changes in body mass index (BMI) over the treatment period. Additional assessments include nutritional status, inflammatory markers, and quality of life. The study aims to determine if nanocrystalline MA can improve weight and reduce muscle loss during cancer treatment. The total treatment and observation period is up to 8 weeks.

Researchers are evaluating the safety, tolerability, and pharmacokinetics of a single dose of Semaglutide Nasal Spray compared with placebo and Semaglutide Injection in adults who are overweight or obese. This phase I study focuses on adults aged 18 to 65 years with a body mass index (BMI) between 27.0 and 35.0 kg/m². Participants must have stable weight with no significant recent changes and no plans for conception during and shortly after the study. The study compares three treatments: Semaglutide Nasal Spray (WL1006), placebo, and Semaglutide Injection (Wegovy®). Participants receive a single dose, and the study monitors how the drug is processed in the body over 36 days. This includes measuring drug concentration levels, elimination rates, and bioavailability. Safety is also assessed through monitoring adverse events, vital signs, blood tests, and ECGs throughout the study period. Participants will undergo multiple assessments from Day 1 to Day 36 after administration, including physical exams, blood and urine tests, vital signs measurements, and ECGs. Researchers will track treatment-emergent adverse events and monitor laboratory values such as blood counts and biochemical markers. The study also includes thyroid function and virology tests. Participation involves close monitoring to evaluate both the drug’s effects and its safety profile over the course of more than a month.

Researchers are studying patients with diabetic kidney disease (DKD) to understand how intensive weight loss treatments might affect kidney health and to develop a model predicting kidney improvement after weight loss. This study focuses on people aged 18 to 65 years who have DKD and are either overweight or have abdominal obesity. The goal is to evaluate the effects of weight loss on the progression of their kidney disease. Participants will receive either bariatric surgery, including laparoscopic sleeve gastrectomy or laparoscopic gastric bypass, chosen based on beta-cell function, or non-surgical treatment involving diet management, exercise, metformin, GLP-1 receptor agonists, and other weight loss medications. These treatments aim to achieve intensive weight loss to study their impact on kidney health. During the study, researchers will monitor total weight loss at 1, 3, 6, and 12 months after intervention. They will assess kidney function and other health measures to understand treatment effects. The study involves regular follow-ups to track patient progress, with a focus on safety and treatment outcomes over one year.

Researchers are evaluating two different methods to increase fruit consumption among Swedish students aged 7 to 19 years. This study, part of a European project focused on childhood obesity prevention, aims to improve healthy eating habits by providing fruit in schools and testing whether adding an awareness campaign increases fruit intake and affects snacking behaviors. The study focuses on understanding which approach better supports healthy dietary habits in school settings. The intervention involves placing fruit stands with two types of fruit in central areas of participating schools, where students can freely take fruit during school hours. Digital scales built into the stands track the amount of fruit taken by weighing the fruit at multiple times throughout the day. In some schools, an additional awareness campaign with posters and messages is used alongside the fruit stands to encourage fruit consumption. Students use a mobile app to photograph and document all meals and snacks before, during, and after the intervention periods. Participants will be involved in three data collection periods: before the fruit stands are introduced, during the early intervention while fruit stands are available, and after the intervention to assess lasting changes. Researchers collect data through app entries, scale readings, and photographs to monitor fruit uptake, eating patterns, and potential food waste. The main outcome measured is the change in fruit consumption from enrollment until 10 weeks after. The study also evaluates the feasibility of digital monitoring and aims to support future strategies for promoting fruit consumption in schools.

Native American employees of Twin Arrows Casino are being studied to evaluate a culturally relevant, micronutrient-dense plant-rich (mNDPR) dietary intervention aimed at reducing obesity and related diseases. This research addresses the higher risks of obesity and diabetes faced by Native Americans and tests whether this specific nutrition program can improve health outcomes and reduce healthcare costs over one year. The study uses a randomized controlled design with a wait-list control group to compare results. Participants are randomly assigned to either an experimental group receiving a 12-week mNDPR nutrition intervention or a wait-list control group that receives the same intervention after 12 weeks. The intervention is led by Native American Masters of Public Health students trained as Lifestyle Coaches who conduct weekly group sessions tailored to accommodate different work shifts. The initial session lasts 2 hours followed by weekly 1-hour coaching sessions using motivational interviewing and nutrition education based on the mNDPR protocol, which emphasizes plant-based, micronutrient-rich foods with specific calorie breakdowns. Participants have health and wellness assessments at baseline and week 13. The experimental group also completes a 24-hour diet recall at week 26 to assess long-term diet changes, while the wait-list control completes health measures at week 26. Healthcare cost data for both groups are collected at week 52. The main outcome measured is change in Hemoglobin A1c after 13 and 26 weeks, along with other health markers and wellness indicators throughout the study.