Obesity Clinical Trials

October 2013 - February 2017
The study will examine the role of adipose tissue in vitamin D physiology, particularly its role as a depot. the study is randomized double blind and placebo controlled. Sponsor: University of Tromso

October 2013 - April 2018
The investigators overall hypothesis is that exacerbation of endoplasmic reticulum (ER) stress in the liver is associated with significant alterations in phosphatidylcholines that drive the NASH phenotype in obese humans. The investigators plan to examine this hypothesis in a well-characterized cohort of obese subjects that are scheduled for bariatric surgery. Methyl-D9-choline chloride will be infused before and after a 2-week high fructose or glucose feeding to determine the biosynthesis and kinetics of secretory lipoprotein phospholipids. It is proposed that phospholipid metabolism play an important role in the pathogenesis or etiology of fatty liver in non-alcoholic conditions through mechanisms that invoke ER and oxidative stress responses. Sponsor: Vanderbilt University

September 2013 -
With the increasing rates of child obesity and diabetes, innovative programs are needed that capture children's attention and permit behavior change messages to get through. Serious video games with their immersive stories offer one such promising alternative. "Escape from Diab" and "Nanoswarm: Invasion from Inner Space" are two video games guided in their design by four behavior change theories that were targeted at increasing fruit, vegetable and water intakes, and lowering sedentary behaviors, and have been shown to change these children's diet and physical activity practices in a pilot study with a relatively low risk sample. In light of this preliminary success, it is important to test the efficacy of these interventions on diabetes risks (i.e. fasting insulin) with higher risk children (which should increase the effect) and with a larger sample to learn how the games change behaviors using mediating variable analyses. A study with 444 high risk (85%tile<BMI<99%tile) 10 to 12 year old children is proposed. Children will be randomly assigned to treatment or control groups. The control group will be a wait-list control and receive the intervention at the end of the second post assessment. Video games are a promising low cost approach to intervention since the games have already been developed, and can be broadly disseminated by simply reproducing and distributing their DVDs. No study has appeared that tested the effects of theory based video games on diet and physical activity that was adequately powered to investigate mediating variables. Conducting the mediating variable analyses will inform the design of future video games and enhance their ability to promote health behavior change. While using video games for health promotion is controversial, this study will establish whether video games efficaciously change diabetes risks (especially insulin, diet and physical activity) among children. Sponsor: Baylor College of Medicine

September 2013 -
Gestational diabetes mellitus (DM) is one of the most frequent complications in pregnant patients with polycystic ovary syndrome (PCOS) in 20-40% of cases and ~40% of patients with gestational DM are likely to have underlying polycystic ovarian morphology. A recent meta-analysis demonstrated a significantly higher risk of developing gestational DM [odds ratio (OR) 2.94; 95% confidence interval (CI): 1.70-5.08] in the PCOS population. Metformin is an oral biguanide insulin sensitizer used for treating type-2 DM and recently introduced to treat PCOS. At the moment, preliminary data seem to reassure regarding the use of metformin in PCOS patients showing benefits for maternal and fetal outcomes, without serious adverse events. Furthermore, well-designed randomized, controlled trials (RCTs) on this issue are lacking, thus it is not possible to either suggest or advice against the use of metformin during pregnancy for reducing gestational DM risk. To this regard, PCOS represents an intriguing model of "high-risk patients" to evaluate the efficacy of metformin for preventing DM development. The present protocol firstly will evaluate the effects of metformin administration in reducing incidence of gestational DM in high-risk patients, such as pregnant PCOS patients. Sponsor: University Magna Graecia

August 2013 - August 2017
In this study, we will test the central hypothesis that enhancement of vitamin D status in obese and overweight children will improve their vascular health and their cardiovascular disease (CVD) and metabolic syndrome risk profile. Sponsor: University of Pittsburgh

June 2013 - April 2018
Obesity is an important risk factor for osteoporosis and fractures. With the growing prevalence of obesity in the U.S., understanding the pathophysiology of bone loss in this population is of importance to public health. Growth hormone (GH) is a critical mediator of bone homeostasis and is markedly reduced in obesity. Our preliminary data suggest an important role for the GH/insulin-like growth factor 1 (IGF-1) system in the pathogenesis of bone loss in obesity. The development of novel imaging techniques provides an opportunity to investigate the effects of GH on skeletal structure and strength, which will provide insights into the pathogenesis of obesity related bone loss. Understanding the pathophysiology of bone loss in obesity may help identify new treatment targets for this important complication. The investigator hypothesizes that low-dose GH administration for 18 months will increase bone mineral density (BMD), microarchitecture and strength. These effects will be mediated by effects on body composition, a decrease in the bone marrow fat/osteoblast differentiation factor Pref-1 with decreases in bone marrow fat, and effects on inflammatory cytokines, serum lipoproteins and vitamin D. Importantly, elucidating the effects of GH on skeletal physiology has the potential to lay the basis for development of osteoporosis therapies that manipulate GH/IGF-1 axis cellular and downstream targets. Sponsor: Massachusetts General Hospital

June 2013 - December 2016
This study will examine whether hesperidin, a major component of citrus fruits, affects how the body responds to insulin in healthy and obese people. Laboratory studies suggest that hesperidin treatment lowers blood pressure, lowers blood sugar and increases blood flow. This study will see if hesperidin improves insulin resistance or insulin's effects on blood flow in people with insulin resistance. Healthy normal weight or overweight people between 21 and 65 years of age may be eligible for this study. Participants are randomly assigned to take hesperidin or a placebo (inactive dummy pill ) for a 4-week treatment phase. Sponsor: University of Maryland

June 2013 - December 2015
The aim of this study is to find out the safety and efficacy of Laparoscopic Greater Curvature Plication (LGCP) procedure. This study procedure is an alternative restrictive weight loss surgery that has the potential to reduce the complications associated with gastric banding and sleeve gastrectomy by creating a small sized stomach without the use of an implant and without cutting stomach. Sponsor: New York University School of Medicine

June 2013 - October 2014
The purpose of this study is to evaluate efficacy of orlistat 60 mg compared to placebo on weight loss and abdominal adiposity in obese adults treatment. Sponsor: EMS

June 2013 - June 2015
Obesity is becoming more common and disproportionately affects the younger generation, the poor and certain ethnic groups. Nearly 50% of reproductive aged women are obese or overweight. Obesity during pregnancy leads to higher rates of hypertensive disorders, stillbirth, less successful breastfeeding, obesity in their offspring, postpartum depression, and higher weight retention postpartum. Dietary counseling can prevent excessive maternal weight gain and is more effective than activity-based interventions. The two objectives of this study are 1) to use community-based techniques to improve dietary counseling for high risk women and 2) to randomize obese women to dietary counseling at Truman Medical Center and measure their success. The hypothesis is that dietary interventions can successfully be tailored for high risk women and that excessive weight gain during pregnancy can be avoided. Sponsor: University of Missouri, Kansas City