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Obesity, Morbid clinical trials

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NCT ID: NCT02142660 Completed - Severe Obesity Clinical Trials

Sprayshield as Adhesion Barrier System for Obese Patients

Sprayshield
Start date: January 2012
Phase: N/A
Study type: Observational

The application of SprayShield during a laparoscopic band removal (first surgical step) will be evaluated to see if the postoperative adhesions between the stomach, the left liver and the diaphragm are not severe, facilitating the surgical surgical step of a gastric bypass or a sleeve gastrectomy.

NCT ID: NCT02137330 Completed - Clinical trials for Glycemic Intolerance

Obalon in Children With Severe Obesity

Obalon
Start date: January 2014
Phase: Phase 3
Study type: Interventional

The ongoing global rise in the prevalence of overweight and obesity among all ages and among all ethnic groups, figures into a real epidemic phenomenon. This is accompanied by a higher incidence in serious health risks, already present at an early age, "switching-on" the engine towards obesity-related co-morbid diseases and morbid obesity. Weight loss is the only way to avoid systemic and cardiovascular complications of obesity. Weight loss devices have been recently introduced in bariatric surgery, also in children. They mostly require invasive procedures to be applied. Mini-invasive devices would be needed to obtain weight loss in the pediatric population, since the early age of involved patients. Obalon intragastric balloons, are swallowable devices. They are filled with liquid or air, and have been used to induce weight loss in obese adults. The investigators aimed to perform a pilot study in pediatrics, and monitor weight loss, metabolic and cardiovascular parameters modifications, after up-to-3 Obalon® Gastric Balloons placement.

NCT ID: NCT02124993 Completed - Severe Obesity Clinical Trials

The Effect of Sleeve Gastrectomy on Food Preference

FPQ
Start date: April 2013
Phase: N/A
Study type: Observational

This is a questionnaire asking about the sleeve gastrectomy surgery and how has it altered food preferences before and after surgery.

NCT ID: NCT02122029 Completed - Morbid Obesity Clinical Trials

Lifestyle vs.Surgery for Morbid Obesity Treatment

Start date: February 2003
Phase: Phase 3
Study type: Interventional

The purpose of the current study is to determine whether an intensive lifestyle intervention was as effective as surgery to treat morbid obesity nine years post-intervention.

NCT ID: NCT02121808 Completed - Morbid Obesity Clinical Trials

EPO2-PV: Evaluation of Pre-Oxygenation Conditions in Morbidly Obese Volunteer: Effect of Position and Ventilation Mode

EPO2-PV
Start date: April 2014
Phase: N/A
Study type: Interventional

The risk of complications associated with airway management in obese patients is significant. The results of pre-oxygenation allow a prolonged non-hypoxic apnea time for the clinician. The increase in FRC and non-hypoxic apnea time is correlated. The best condition to accomplish the pre-oxygenation in morbidly obese patient is still undetermined in medical literature. This study is designed to evaluate the effect of different positions combined with different ventilation modes during the pre-oxygenation phase of anesthesia's induction. EPO2: PV will evaluate the effect of different combinations of positions and ventilation modes on pulmonary volumes (mainly functional residual capacity) in a morbidly obese volunteer.

NCT ID: NCT02113696 Completed - Morbid Obesity Clinical Trials

Intake of Omega 3 in Morbidly Obese Patients

Start date: May 2014
Phase: N/A
Study type: Interventional

Ingestion of capsules of omega 3 EPA and DHA, with 1.8 g of EPA and 1.2 g DHA for morbidly obese patients, will improve the inflammatory status? C-reactive protein? Weight?

NCT ID: NCT02072395 Completed - Morbid Obesity Clinical Trials

Gastric Plication and Banding

GP and Band
Start date: February 2012
Phase: Phase 2
Study type: Interventional

The purpose of the study is to assess the efficacy of a hybrid laparoscopic surgical procedure for treatment of morbid obesity, Gastric Plication (G)) and Gastric Banding.

NCT ID: NCT02070237 Completed - Obesity Clinical Trials

Comparing Anti-XA Levels in Post-Cesarean Patients Undergoing Enoxaparin Thromboprophylaxis

Start date: August 2013
Phase: Phase 1
Study type: Interventional

Pregnant and recently postpartum women are at significantly higher risk of developing a blood clot in their arms or legs known as a deep venous thrombosis (DVT) and/or a blood clot in their lungs known as a pulmonary embolism (PE) compared to their non pregnant counterparts. It is estimated that this risk increases anywhere from 4 to 50 times higher in pregnant versus non-pregnant women and further increases almost 11 fold in the post partum period. This risk is almost doubled when the patient undergoes cesarean delivery. In 2011, the American College of Obstetricians and Gynecologists (ACOG) issued updated guidelines stating that for patients undergoing cesarean delivery with additional risk factors for clot or thromboembolism, protective (prophylactic) treatment with low molecular weight heparin (LMWH) a type of blood thinner should be considered. However, no specific guidelines about which risk factors should be considered, or what medication doses should be used were provided. The American College of Chest Physicians (ACCP) Evidence-Based Clinical Practice Guidelines published in 2012 delineated who should be given prophylaxis based on various risk factors, however acknowledged that the recommendations were based on weak quality evidence. ACOG endorses either once or twice a day dosing for high risk patients after delivery and states that adjustments for obese women should be made on a case by case basis. However, there are limited studies on the dosing of LMWH in specific subpopulations including post operative patients, pregnant patients and obese patients. All of these studies have urged further investigation of the correct dosing for these high risk subjects due to changes associated with pregnancy and the level of medication in the blood that may put these patients at higher risk of venous thromboembolism. Many previous studies have shown that women in these high risk categories do not achieve protective levels of the medication measured with a laboratory test; anti Xa level. The investigators hypothesize that due to their dual risk, obese post-operative recently pregnant women may not be adequately protected with the daily fixed dose and might need more frequent dosing to protect them. The objective of this study is to assess what proportion of women achieve the desired anti Xa level with the fixed daily dose versus twice daily weight based dosing (0.5 mg/kg).

NCT ID: NCT02067585 Completed - Morbid Obesity Clinical Trials

An Analysis of Lipid and Glucose Metabolism Following Bariatric Surgery

Start date: February 2010
Phase: N/A
Study type: Interventional

Bariatric surgery induce remarkable weight loss and improvement or resolution of type 2 diabetes. Obesity is the primary risk factor for type 2 diabetes, and 90% of all type 2 diabetics are obese. Type 2 diabetes resolves post-operatively in 84-98% after bypass and 48-68% after restrictive procedures. Obesity leads to elevated plasma free fatty acids and subsequently to excessive accumulation of triglyceride in peripheral tissues, which is an independent risk factor for insulin resistance and type 2 diabetes. Bariatric surgery is associated with dramatic decrease in plasma free fatty acids and other lipids. This study will clarify the relationship of changes in fatty acid and other lipid metabolism to improved insulin sensitivity after different bariatric procedures ('restrictive' - laparoscopic adjustable gastric band and 'hybrid' - laparoscopic roux-en-y gastric bypass) and compare them with non-surgical obese patients. This will allow the investigators to refine indications for these procedures especially in patients with type 2 diabetes. The investigators will analyze whether surgical bypass of the upper small bowel plays a critical role in the resolution of type 2 diabetes and improvement in lipid metabolism. The investigators will achieve this by comparing gastric banding and gastric bypass in a collaborative research study involving obesity surgeons, physicians and lipid researchers.

NCT ID: NCT02049944 Completed - Obesity Clinical Trials

Increased Cefazolin During Cesarean Delivery in Obese Population

Start date: August 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether an increased prophylactic dose (3 grams) of cefazolin at the time of cesarean delivery has superior coverage in adipose tissue than the current established dosing of 2 grams. The tissue and serum concentration values, when using an increased prophylactic dose, can then be compared to our pilot study assays in hopes of determining an optimal dosing for the obese and morbidly obese populations undergoing cesarean delivery. A previous study performed at University of California, Irvine (UCI) and Long Beach Memorial Medical Center/Miller Children's Hospital (LBMMC) showed that the standard dose of antibiotics (2 grams of cefazolin) did not provide adequate coverage for all organisms in the obese and extremely obese populations. The purpose of this research study is to evaluate whether in increased dose of antibiotics given before cesarean delivery (3 grams of cefazolin) will reach adequate levels in adipose (fat cells underneath the skin) and serum (blood) samples. In addition, researchers hope to evaluate if/how the mother's weight has an effect on the levels of antibiotics in the tissues (a group of similar cells). This follow up study (prior study HS# 2009-7015 at UCI) will enroll obese (Body Mass Index (BMI) of 30-40) and morbidly obese (BMI >40) women to receive an increased dose of prophylactic cefazolin at time of scheduled cesarean delivery at both UCI and LBMMC. Researchers hope to enroll a total of 35 women overall.