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Obesity, Morbid clinical trials

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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.

NCT ID: NCT02037516 Completed - Morbid Obesity Clinical Trials

Does Residual Muscular Weakness Lead to an Increase in Respiratory Complications in Bariatric Patients?

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

The purpose of this study is to determine if residual weakness after weight loss surgery leads to an increased risk of respiratory complications in the postoperative period.

NCT ID: NCT02035397 Active, not recruiting - Obesity, Morbid Clinical Trials

Intragastric Injections of Botox for the Treatment of Obesity

Start date: February 2014
Phase: Phase 2
Study type: Interventional

One possible angle for treating obesity could be slowing down the gastric emptying time. By prolonging the gastric emptying time, the person would ideally experience increased sensation of satiety, and in the long run reduce food intake. If such a treatment provides a clinically significant weight loss, this could be an alternative for surgical procedures, avoiding the risk for perioperative complications as well as complications in the long run. There are now several pilot studies documenting that intragastric treatment with botulinum toxin A (BTA) can be effective, although the treatment perspective is short and do not include repeated injections. However, they demonstrate that BTA-injections are safe for the patient. The treatment is administered by endoscopy.

NCT ID: NCT02033577 Recruiting - Severe Obesity Clinical Trials

Effects of Long Biliopancreatic Limb Versus Long Alimentary Limb in Superobesity, a Randomized Study

BMI>50
Start date: August 2011
Phase: N/A
Study type: Interventional

Surgical bypassing of a longer section of the small bowel (when doing a gastric bypass operation) gives better results on body weight in the superobese. We do not yet know whether it is beneficial to exclude more of the proximal small bowel or more of the distal. Side effects of bypassing can also be different. Study aims at clarifying possible differences in effects and side-effects of these two surgical-technical variations.

NCT ID: NCT02033265 Completed - Obesity Clinical Trials

Ultrasound-Guided Axillary Brachial Plexus Block: Influence of Obesity

Start date: September 2013
Phase:
Study type: Observational

Axillary brachial plexus block (freezing the nerves in armpit) is commonly performed as a primary anesthetic technique for the elbow/ forearm or hand surgery. These nerves are identified using ultrasound and nerve stimulator (by stimulating the nerves using a small current through the needle). Axillary brachial plexus block has been shown to result in better pain relief, less nausea, vomiting and early discharge from hospital. The use of these nerve blocks have also shown to decrease the duration of hospital stay, decreased side effects of opioids painkillers and better satisfaction scores over the conventional use of intravenous and oral pain medications. These beneficial effects are particularly useful for patients who are overweight or obese. A study by Hauouz et al published in Anesthesia and Analgesia in July 2010 suggests that the success rate of brachial plexus block is lower for obese and overweight patients. However, ultrasound guidance was not used for performing axillary brachial plexus block in this study. We propose that with usage of ultrasound guidance the success rate of brachial plexus block will be similar in obese and non-obese patients. In this study, we want to compare the success rate of axillary brachial plexus block for obese and non-obese patient groups. We would also like to look at performance time, complications and patient satisfaction for our study population.

NCT ID: NCT02029677 Active, not recruiting - Morbid Obesity Clinical Trials

Appetite Suppression / Hormone Study Control Group

Start date: September 2008
Phase:
Study type: Observational

The purpose of this research study is to determine how changes in levels of obesity-related hormones in the gastrointestinal tract following Laparoscopic Adjustable Gastric Banding (LAGB) surgery may lead to a decrease in appetite and weight loss. Learning exactly how the Lap Band works may help us to develop new, less invasive treatments for morbid obesity. This knowledge may also lead to the development of preventive, cost-effective treatment strategies. As a control subject, participants will provide a comparison for changes in these hormones with medical weight loss compared to weight loss after LAGB surgery.

NCT ID: NCT02024542 Recruiting - Morbid Obesity Clinical Trials

Metabolic Responses to Bariatric Surgery

Start date: February 2011
Phase:
Study type: Observational

Research the genetic and biomechanical markers of human adipose tissue on patients with morbid obesity. Additional tissue/fluid collection is also gathered during the time of surgery.