Obesity Clinical Trials

The main purpose of this Phase 2 double blind, placebo controlled crossover clinical study is to demonstrate the efficacy and safety of CXA-10 in obese adult asthmatics. Obesity induces a chronic systemic inflammatory state characterized by impaired adipokine signaling, pro-inflammatory cytokine responses, inflammatory cell activation and enhanced generation of oxidative inflammatory mediators. This impacts the lung, increasing the severity of asthma and its exacerbations. This research will evaluate how a synthetic nitro-fatty acid (CXA-10, 10-nitro-octadec-9-enoic acid) suppresses the systemic and airway inflammation that contributes to the obese asthmatic phenotype. Current data support the pleiotropic signaling actions of CXA-10 to induce adaptive signaling actions that beneficially modulate adipokine and cytokine expression and inhibit systemic and pulmonary inflammation. The investigators hypothesize that CXA-10 induced signaling responses will alleviate obesity-related airway hyperreactivity in obese adult asthmatics. Read Less

The purpose is to optimize the EMPOWER program by integrating strategies to reduce food cravings, a critical yet often overlooked factor for long-term success in weight management. The objective of this study is to determine the efficacy of craving coping strategies on weight loss outcomes by conducting a randomized controlled trial. Participants will be randomized to receive one of the two strategies to manage food cravings. Read Less

Reduction in food reinforcement appears to be a principal way by which bariatric surgery lowers energy intake to promote weight loss and other health improvements. However, surgical modulation of mechanisms that influence food reinforcement is variable with some patients appearing more resistant to these effects than others. This "resistant" phenotype, characterized by high levels of hedonic hunger (i.e., eating for pleasure in the absence of hunger) and disinhibition (i.e., susceptibility to cues that promote overeating), can undermine surgical efficacy. Bariatric surgery patients who demonstrate this high-risk eating phenotype may benefit from strategies that can directly target neural mechanisms of food reinforcement. Repetitive transcranial magnetic stimulation (rTMS), a noninvasive procedure that delivers magnetic pulses to stimulate or inhibit nerve cells in the brain, has successfully been used to target dysregulated brain reward circuitry to diminish the reinforcing properties of addictive drugs, such as cocaine. rTMS might have a similar effect on people who have a strong drive to eat in response to the reward of palatable foods. No study has directly examined how rTMS impacts the reinforcing value of food and related brain reward processing among people who find food highly reinforcing. The reinforcing value of food can be measured by comparing how much work a person will choose to do to access that food versus an alternative reinforcer (i.e., relative-reinforcing value of food \[RRV\]). In this study, we aim to: (1) determine whether rTMS reduces the RRV relative to money; and (2) measure acute rTMS-induced modulation of reward processing with electroencephalography (EEG). Preoperative bariatric patients (n=10) will attend 2 study sessions, at least 1-week apart, with RRV and reward measures completed while EEG is collected before and after a rTMS session. With condition blinding and counterbalancing, participants will be randomized to active rTMS on one day and sham rTMS on the other day. Participants will arrive fasted in the morning, receive a standardized breakfast, complete the RRV and reward tasks during EEG before rTMS (pre-rTMS EEG), receive rTMS, then complete the RRV and reward tasks during EEG after rTMS (post-rTMS EEG). During the active condition, rTMS will be applied to the dorsolateral prefrontal cortex because this region is functionally and structurally connected to the striatum, an area necessary for reward processes. These procedures will allow for comparison of pre- to post-test rTMS changes in behavioral (RRV) and neural modulation (EEG) of food reward between the active and sham conditions. Read Less

The overall objective of the study is to examine the effect of an 8-hour time-restricted eating intervention on lipid levels and body composition in peri- and recently postmenopausal women with untreated dyslipidemia. Read Less

Patient Power is a patient research network and database (registry) to collect prospective information about demographics, self-reported diagnoses and medications, and willingness to participate in research from participants with rheumatoid arthritis (RA), spondyloarthritis (SpA), other musculoskeletal conditions, chronic neurological conditions like migraine, chronic pulmonary conditions like Chronic Obstructive Pulmonary Disease (COPD), asthma, autoimmune dermatological conditions such as psoriasis, and other chronic inflammatory or immune-mediated conditions. In addition, since patients with chronic conditions often have other co-morbidities like cardiovascular health and obesity-related metabolic disorders, these conditions will also be included. Participants will provide information from their smartphones or personal computers. The information will be used by researchers and clinicians to help patients and their providers make better, more informed decisions about treatment of chronic conditions. Read Less

Several methods for closure of trocar wounds are known in laparoscopic surgery including mostly transcutaneous or subcuticular suture or adhesive paper tape. Studies comparing laparoscopic incision closure in bariatric population are limited .This is a prospective study that will be conducted in a single tertiary medical center. s obese population comprise most of our surgical candidates, and due to the aforementioned, the aim of our study is to compare the outcomes of both techniques in obese women. Read Less

The purpose of this research study is to understand why certain HIV medication regimens (called anti-retroviral or ARV medications) cause more weight gain than others. In this research, the investigators will compare micro-RNA profiles of people who take Symtuza(darunavir(D)/cobicistat(C)/emtricitabine(F)/tenofovir alafenamide (TAF))\[D/C/F/TAF\] with those who take Biktarvy(bictegravir(B)/emtricitabine(F)/tenofovir alafenamide (TAF))\[B/F/TAF\] and try to correlate this with the change in body weight and BMI over a course of 48 weeks. The investigators will also attempt to monitor the calorie intake of the participants in the two groups and correlate it with treatment-induced weight gain. Micro-RNAs are small molecules that are produced naturally in the human body, and which are responsible for modifying the expressions of genes. They have the potential to be used in diagnostic and therapeutic medicine and their putative role has been explored in many diseases across many clinical trials. By doing this research, the investigators hope to learn more about their role in HIV disease and its correlation with treatment-induced weight gain. Read Less

This study will test whether metformin administration can ameliorate androgen (male hormone) overproduction in overweight pubertal girls with androgen excess. The investigators hypothesize that improvement in insulin sensitivity by 12 weeks of metformin administration will improve androgen levels after adrenal stimulation testing with adrenocorticotropic hormone (ACTH) or ovarian stimulation testing with recombinant human chorionic gonadotropin (rhCG). Read Less

Whether 12 weeks of spironolactone can reduce androgen production from ovaries and adrenal glands of girls with obesity and androgen excess Read Less

This study is for older children, adolescents, and young adults with B-cell Acute Lymphoblastic Leukemia (B-ALL). Higher amounts of body fat is associated with resistance to chemotherapy in patients with B-ALL. Chemotherapy during the first month causes large gains in body fat in most people, even those who start chemotherapy at a healthy weight. This study is being done to find out if caloric restriction achieved by a personalized nutritional menu and exercise plan during routine chemotherapy can make the patient's ALL more sensitive to chemotherapy and also reduce the amount of body fat gained during treatment. The goals of this study are to help make chemotherapy more effective in treating the patient's leukemia as demonstrated by fewer patients with leukemia minimal residual disease (MRD) while also trying to reduce the amount of body fat that chemotherapy causes the patient to gain in the first month. Read Less

This project evaluates the effectiveness of an evidence-based intervention (HEALTH-P2) to prevent excessive weight gain from pregnancy through 12 months postpartum when disseminated and implemented in real-world settings, through Parents as Teachers. To enhance the impact of HEALTH-P2, the study also evaluates implementation outcomes from the training curriculum (implementation strategy) and external validity when HEALTH-P2 is implemented within this national home visiting organization. This partnership has potential for significant impact on obesity and chronic diseases such as cardiovascular disease and diabetes. Read Less

Men in the United States have an exceptionally high prevalence of overweight and obesity, i.e., 71.3%, and 42% of men are currently attempting weight loss. However, men are dramatically underrepresented in weight loss programs. Attempts to modestly adapt standard weight loss programs have seen only minimal success. Mobile applications (mHealth apps) have attractive features, but have low male enrollment and poor efficacy as conventionally delivered. A gamified mHealth program offers the possibility of engaging men and enhancing efficacy given that (1) video gaming is highly appealing to men; (2) gamification features (e.g., digital rewards for attaining "streaks" and milestones, competition) are known enhance enjoyment and motivation and facilitate desired behaviors; and (3) "neurotraining" video games featuring repetitive action mechanics, adaptive difficulty, and feedback can train inhibitory control, a basic brain capacity to inhibit intrinsically-generated approach responses that is strongly linked to body mass and the consumption of high-calorie foods. This project evaluates long-term engagement and outcomes of a professionally-designed, game-based weight loss program. As such, 228 overweight men will be randomized to: (1) a 12-month mHealth weight loss program that includes digital self-monitoring, simplified and self-selected dietary targets, physical activity and a control (sham) non-game neurotraining, or (2) a fully-gamified version of this same program, comprised of a behavior change program featuring team-based competition, digital reinforcers for attainment of streaks and milestones, and an integrated neurotraining video game. Aims include evaluating the efficacy of the gamified program in terms of weight loss, diet and physical activity at 12 months, as well as evaluating hypothesized mediators (inhibitory control and engagement), (enjoyment and compliance) and moderators (baseline frequency of video game play and implicit preferences for Inhibitory Control Training-targeted foods). Read Less