Weight Loss

Researchers are investigating whether a multifactorial lifestyle intervention involving a Mediterranean diet with reduced calories and increased physical activity can help middle-aged adults (30-50 years) with metabolic syndrome lose weight and maintain that weight loss over time. The study also aims to understand the social and demographic challenges people face in sticking to these healthy habits and to examine the lifestyle patterns of this group. Participants will be randomly assigned to one of two groups. One group will follow general lifestyle recommendations from primary healthcare providers, while the other will receive an intensive program that includes monthly individual and group sessions over 6 months to encourage a Mediterranean diet with 25% fewer calories and physical activity based on WHO guidelines. The goal for the intervention group is to reduce their initial weight by 5-10% within 6 months and maintain this loss after 12 months. Throughout the study, participants will undergo assessments including measurements of weight, waist size, blood sugar, triglycerides, and glycated hemoglobin to monitor changes in their health. Data on demographics, diet, clinical parameters, and laboratory tests will be collected. After the 6-month intervention, a follow-up at 12 months will evaluate how well participants maintain their lifestyle changes. The study emphasizes tracking adherence and identifying factors that help or hinder long-term weight loss maintenance.

Researchers are evaluating whether taking tirzepatide before bariatric surgery can improve health outcomes for people with obesity and related medical conditions. This study aims to see if tirzepatide reduces inflammation in tissues and blood before surgery and how these changes relate to weight loss, metabolic improvements, and fewer complications after surgery. The trial is a Phase 4 interventional study comparing patients who take tirzepatide with those who do not before their planned surgery. Participants who are assigned to the tirzepatide group will self-inject 2.5 mg of tirzepatide once weekly for three months before surgery, following dose escalation instructions if needed. Both groups will receive education on dietary and lifestyle changes. During the three months before surgery, participants will visit the endocrine clinic monthly for drug prescription and side effect monitoring. The study continues through the surgery and post-surgery follow-up periods. Throughout the study, participants will keep a diary of drug use and side effects, and researchers will measure inflammatory markers such as C-reactive protein, interleukin 6, tumor necrosis factor, leptin, adiponectin, and RAAS at baseline, three months after drug use, and several times after surgery. Weight, blood pressure, blood sugar, cholesterol, and surgical complications will also be tracked up to one year after surgery. Participant involvement includes regular clinic visits, lab tests, and monitoring to assess the impact of tirzepatide on surgical outcomes and inflammation.

Researchers are evaluating a magnetic-assisted surgical technique for revisional bariatric surgery, specifically converting sleeve gastrectomy to Roux-en-Y gastric bypass (RYGB) combined with hiatoplasty. This approach addresses long-term problems such as gastroesophageal reflux disease (GERD) in patients who have undergone laparoscopic gastric sleeve (LGS) surgery. The study aims to assess the surgical procedure and its outcomes in patients who are candidates for bariatric surgery with obesity. The surgery is performed using magnetic assistance to improve visualization and manipulation during key steps. It involves placing a single port in the umbilicus and an additional trocar, using magnets for liver retraction, dividing the omentum, repairing hiatal hernia, creating the gastric pouch, measuring and connecting intestinal limbs, and closing defects. A methylene blue leak test is done to check for leaks, and the entire Roux-en-Y gastric bypass is completed with magnet-assisted maneuvers. Participants undergo this bariatric procedure with magnetic assistance and are monitored for complications within 30 days, device malfunction within 1-2 hours post-procedure, and surgical time within 30 days. The study includes evaluations of surgical field exposure, anastomosis construction, and hernia repair. The total participation timeline includes the surgical procedure and follow-up assessments up to 30 days after surgery.

Researchers are evaluating the effectiveness of a six-month virtually-delivered dietary education program called PEDALL to prevent overweight and obesity during maintenance chemotherapy in children and adolescents with acute lymphoblastic leukemia (ALL). The study focuses on English and Spanish speaking families and considers key genetic and sociodemographic risk factors that may affect weight gain during treatment. Participants will be randomly assigned to one of two groups: the PEDALL intervention group or the standard of care (SOC) group. The PEDALL group will receive 26 contact hours of specialized nutrition education through weekly one-hour virtual sessions over six months. The SOC group will receive printed educational materials and nutritional care according to their institution's usual practices. During the study, participants and their caregivers will engage in nutrition education and counseling sessions. Researchers will assess weight status, body mass index trajectories, lifestyle behaviors, and the influence of genetic and sociodemographic factors over time. The main goal is to prevent unhealthy weight gain during maintenance chemotherapy and improve long-term health outcomes for childhood ALL survivors. The study will last up to 3.5 years for primary outcomes, with additional follow-up extending to four years.

Researchers are investigating the relationship between obesity and type 2 diabetes, conditions influenced by both genetic and environmental factors. This study aims to better understand how different genetic variations affect gene expression in tissues involved in glucose and lipid metabolism, which may contribute to what is called "diabesity," a combined condition of diabetes and obesity. The study uses advanced genomic techniques and bioinformatics to analyze these factors in both humans and animal models. Participants in this observational study are grouped based on their body mass index (BMI) and diabetes or glucose intolerance status. Groups include individuals with BMI ≥ 35 kg/m2 with diabetes, glucose intolerance, or without diabetes, as well as those with BMI < 27 kg/m2 and BMI between 27 and 35 kg/m2 without diabetes. Samples are collected during abdominal surgeries such as bariatric surgery or cholecystectomy to study gene expression and metabolic pathways. During the study, researchers collect biological samples at baseline and follow participants over several years to assess changes in gene expression and insulin resistance. They also evaluate clinical and biological features before and after bariatric surgery at 1, 2, and 5 years. The primary measurement focuses on gene expression in tissues related to glucose metabolism. This long-term observation helps to understand the genetic and phenotypic factors influencing obesity and diabetes, with participation lasting up to 5 years.

Locally advanced cervical cancer is a common cancer in women worldwide and often leads to serious nutritional problems like malnutrition and cachexia. This condition worsens during concurrent chemoradiotherapy (CCRT), especially due to treatments like platinum-based drugs, which cause muscle loss and weight loss, increasing mortality risk. Researchers are studying nanocrystalline megestrol acetate (MA), a drug that may help stimulate appetite and reduce inflammation, aiming to improve nutritional status and treatment outcomes in these patients. This clinical trial compares two groups of patients with locally advanced cervical cancer undergoing CCRT: one group will receive nanocrystalline megestrol acetate oral suspension at 625 mg daily for up to 8 weeks, and the other will receive CCRT alone. The nanocrystalline form of MA has better absorption and faster onset of effect than traditional forms, potentially leading to improved weight gain and reduced muscle wasting. The study will measure body mass index (BMI), appetite, lean body mass, treatment completion, and side effects related to radiotherapy. Participants will be monitored for changes in BMI during the 8-week treatment period, alongside assessments of appetite using a specific scale, survival rates, and inflammatory markers. Regular lab tests will evaluate organ function and safety. The trial will also track adverse events and quality of life. The total participation duration for each patient is up to 8 weeks of treatment, with ongoing assessments to understand the drug's impact on nutrition and cancer treatment tolerance.

Researchers are evaluating the safety, tolerability, and how the body processes Semaglutide Nasal Spray compared to a placebo and a known injection in adults who are overweight or obese. This Phase I clinical trial aims to better understand the effects of the nasal spray formulation of Semaglutide in this population. The study is sponsored by Shanghai World Leader Pharmaceutical Co., Ltd. and focuses on adults aged 18 to 65 years with specific body mass index ranges. Participants will receive either the Semaglutide Nasal Spray, placebo, or a Semaglutide injection (Wegovy®) in different randomized groups. The study involves a single-dose administration and includes several cohorts receiving various combinations of the nasal spray and placebo or the injection. Treatments are given once, and the study monitors the participants for up to 36 days after administration to assess drug levels and effects. During the study, participants will undergo various evaluations including blood tests, vital signs monitoring, physical examinations, electrocardiograms (ECGs), and urine analyses from Day 1 to Day 36. Researchers will measure how much of the drug reaches the blood, how long it stays, and any side effects that occur. Antibody levels against the drug will also be checked up to Day 29. Participants will be closely monitored for any safety concerns throughout the study period.

Researchers are evaluating the effects of intensive weight loss treatment on renal outcomes in patients with diabetic kidney disease (DKD), particularly focusing on those with rapidly progressing diabetic nephropathy. The study aims to establish a patient group receiving such treatments and to develop a prediction model for kidney health improvements following weight loss. Participants are divided into two groups: one receiving bariatric surgery, which includes laparoscopic sleeve gastrectomy or laparoscopic gastric bypass based on beta-cell function, and another group receiving non-surgical therapy comprising diet management, exercise, metformin, GLP-1 receptor agonists, and other weight loss medications. The study monitors outcomes at 1, 3, 6, and 12 months after intervention. During the study, participants will have regular assessments measuring total weight loss, kidney function markers such as serum creatinine and glomerular filtration rate, various blood glucose parameters, waist and hip circumference, urinary microalbumin, other urine tests, and medication status. These evaluations help track the impact of the treatments on kidney health and metabolic control over the course of one year.

Researchers are evaluating two approaches to increase fruit consumption among students in Swedish schools. The study is part of a Europe-wide project aiming to promote healthier eating habits and prevent childhood obesity by improving fruit availability in school settings. It compares providing free fruit stands alone versus fruit stands combined with a health-awareness campaign to see which better supports healthy eating. Participating schools are randomly assigned to either have fruit stands offering two types of fruit during school hours or fruit stands plus an educational campaign promoting healthy eating. Digital scales in the fruit stands monitor fruit uptake, while school staff record these measurements. Students use a mobile app to photograph and log all their meals and snacks before, during, and after the intervention to track fruit intake and eating patterns. Students contribute data during three periods: before the fruit stands are introduced, immediately after their introduction, and after the intervention ends to assess lasting effects. Researchers analyze changes in fruit consumption and eating behaviors, as well as monitor food waste using weight-based digital tracking. The study aims to identify effective strategies for promoting fruit intake in schools and supports broader efforts to encourage healthy diets among children and adolescents.

This research aims to evaluate a culturally relevant micronutrient-dense plant-rich (mNDPR) dietary intervention designed to reduce obesity and related disease risks among Native American employees of Twin Arrows Casino. Native Americans face higher rates of obesity and Type II diabetes compared to non-Hispanic Whites. The study involves a randomized controlled trial to assess improvements in physical health measures, wellness, and healthcare costs over one year. Participants will be randomly assigned to either an experimental group receiving a 12-week mNDPR nutrition program or a wait-list control group. The intervention includes a 2-hour initial group session followed by weekly 1-hour coaching sessions led by trained Native American Masters of Public Health students using Motivational Interviewing. Sessions provide nutrition education, cooking demonstrations, workplace dining tours, and social support. The wait-list control group will maintain usual eating habits during the first 12 weeks before receiving the same intervention. Participants will undergo health and wellness assessments at baseline and after 13 weeks, with additional diet recall at week 26 for the experimental group and follow-up measures for the control group. Healthcare utilization will be reviewed at 52 weeks. Researchers will measure changes in Hemoglobin A1c, fasting glucose, insulin, blood lipids, inflammatory markers, blood pressure, and wellness indicators like anxiety and sleep quality. Adherence to the diet will be monitored weekly, alongside attendance and self-monitoring of diet compliance.