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Obesity, Morbid clinical trials

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NCT ID: NCT04132531 Completed - Obesity, Morbid Clinical Trials

Effect of Weight Loss Surgery on Stem Cells.

Start date: May 1, 2018
Phase:
Study type: Observational

Obesity and diabetes are linked to increased risk for health problems such as heart attack, stroke, and death. At the cellular level, obesity and diabetes increase levels of harmful inflammatory cells (M1 macrophages) and decreases levels of protective stem cells (circulating progenitor cells) in the blood. Bariatric (weight loss) surgery is an effective treatment that leads to significant weight loss and improved health in patients with obesity. However, it is unknown if weight loss surgery also replenishes healthy stem cells and decreases inflammatory cells in the body. Therefore, the purpose of this research study is to compare levels of these stem and inflammatory cells before and after bariatric surgery, and to compare to a control group of healthy normal weight participants. The investigators anticipate that inflammatory cell levels will be reduced and stem cell levels and function will be restored after bariatric surgery, similar to levels of healthy normal weight individuals.

NCT ID: NCT04129801 Completed - Severe Obesity Clinical Trials

Muscle Strength in Severe Obese Patients in the Postoperative of Bariatric Surgery

Start date: May 5, 2017
Phase:
Study type: Observational

Excessive fat mass (FM) contributes to changes in the strength and endurance of skeletal muscles. Mid-thigh muscle mass is approximately 2.5 times that of fat mass, but individuals who are obese have increased intra- (fat within muscle cells) and intermuscular fat (fat between muscle cells), establishing a negative influence on strength generation capacity and functional independence. The functional capacity of a skeletal muscle can be assessed based on the muscle's ability to produce strength. The relevance of this study is to identify/analyze the changes in segmental body composition (BC) which might better determine the association between fat free mass (FFM) of the lower limbs and maximum voluntary contraction (MVC), 36 months after bariatric surgery. This study was elaborated and will be performed at the Clinical Hospital in the Medical School of the University of Sao Paulo (HCFMUSP). The patients involved will receive the Informed Consent Form. The sample, consists of 155 adults selected at the ambulatory of the Bariatric and Metabolic Surgery Unit of the Department of Gastroenterology of HCFMUSP in the periods: preoperative, 6 and 36 months after surgery. Patients of both sexes, above 18 years of age, will undergo bariatric surgery performed at the institution. Adult patients over 60 years old, undergoing revision surgery and other surgical techniques will be excluded. Anthropometric variables will be obtained on the same day as the evaluation of BC by trained evaluators. The BC will be measured by In Body 230. BMI (kg/m2) shall be determined by dividing body weight (kg) by height (m) squared. Evaluation of Body Composition and Muscle Strength will be held between 8:00 am and 10:00 am in the Laboratory of Exercise and Movement Studies at the Institute of Orthopedics and Traumatology of FMUSP. BC measurements as FM (% and kg), FFM (% and kg), will be obtained by the indirect noninvasive method of electrical bioimpedance. The dynamometer will be used to evaluate muscle strength extension (Ext) and flexion (Flex) MVC torques for both legs will be carried. The MVC assessed variables should be absolute Ext and Flex torques (Nm), Ext and Flex torques relative to the body weight (Nm/Bw) and Ext and Flex torques relative to FFM (Nm/FFM).

NCT ID: NCT04128735 Completed - Morbid Obesity Clinical Trials

Diastolic Dysfunction in Morbidly Obese Patients Undergo Bariatric Surgery

Start date: October 30, 2019
Phase:
Study type: Observational

Morbidly obese patients are at risk for diastolic cardiac dysfunction, which can lead to adverse event, such as, diastolic heart failure postoperatively. Preoperative screening by transthoracic echocardiogram is difficult due to anatomical challenge, therefore the prevalence of this problem may be underestimated. The investigator would like to perform transesophageal echocardiogram in this group of patients after anesthesia induction to demonstrate the true prevalence of this syndrome.

NCT ID: NCT04118582 Completed - Severe Obesity Clinical Trials

Resting Metabolic Rate is a Predictor of Weight Regain?

Start date: June 1, 2015
Phase:
Study type: Observational [Patient Registry]

he increasing prevalence of obesity in developed countries has also reached Brazil in the last two decades. Conventional treatments are not efficient to sustained weight loss and in some cases, weight reduction in individuals refractory to these methods. Bariatric surgery has been considered as the most efficient long-term treatment. However, numerous studies have reported weight regain in approximately 20% of patients, from the second year of surgery. The objective of this study is to analyze the changes in resting metabolic rate and body composition before, 6 and 36 months after weight loss and its relation to late weight regain. 48 adults of both sexes, above 18 years, will undergo bypass performed the ambulatory of the Bariatric and Metabolic Surgery Unit of the Department of Gastroenterology of HCFMUSP. Patients over 60 years, undergoing revision surgery and other surgical techniques will be excluded. The body weight (kg) will be measured by In Body 230. BMI (kg/m2) shall be determined by dividing body weight (kg) by height (m) squared. Excess weight (kg): difference in preoperative weight versus ideal weight considered for weight for BMI 25kg/m2. Weight loss (kg): pre-surgery weight difference in relation to the lowest weight reached after 18 months. Percentage of excess of weight loss is difference of weight loss in relation to overweight, used as an indicator of success of surgery. Fat mass (%, kg) and fat-free mass (%, kg) will be obtained by electrical bioimpedance 230, 2.0. For resting metabolic rate, the values of VO2 and VCO2 will be collected by indirect calorimetry using Ultima CPX metabolic analyzer. The daily energy expenditure (kcal/day) will be calculated by the Weir equation. keywords: obesity, resting metabolic rate, body composition analysis, bariatric surgery.

NCT ID: NCT04109664 Completed - Clinical trials for Bariatric Surgery Candidate

The Role of Extended Antral Resection on Weight Loss and Metabolic Response After Sleeve Gastrectomy

Start date: January 2016
Phase:
Study type: Observational

Aim: The impact of extended antral resection (AR) after laparoscopic sleeve gastrectomy (LSG) on weight loss changes and metabolic response is still not clearly elucidated with conflicting results. The investigator's retrospective cohort study aimed to determine whether AR is superior to antral preservation (AP) regarding weight loss and resolution of co-morbidities. Methods: Patients were divided into two groups according to the distance of gastric division as AR group (2cm from pylorus) and AP group (6cm from pylorus). Postoperative excess weight loss percentile (%EWL) and total body weight loss percentiles (%TBWL) at the end of first, 6th and 12 months were compared. Secondly, metabolic parameters and complications were compared.

NCT ID: NCT04106661 Completed - Morbid Obesity Clinical Trials

Tai Chi as Physical Activity for Women With Morbid Obesity

Start date: September 2, 2016
Phase: N/A
Study type: Interventional

This study investigated the use of Tai Chi as a feasible form of physical activity for women with morbid obesity utilizing an instructional digital video disc (DVD). Two groups of women with morbid obesity (body mass index of >40) were placed into the Tai Chi intervention group or the control group. Initial function was assessed with a series of tests and then repeated after 8 weeks. During the 8 weeks, the Tai Chi intervention group met once a week for 45 minutes to participate in a group exercise class. The control group was asked to continue their regular activity. At the end of the 8 weeks, both groups were reassessed with the same tests from the start of the study. The investigators hypothesized that the Tai Chi group would show more improvement in their functional scores for strength, balance and quality of life than the control group.

NCT ID: NCT04095104 Completed - Obesity, Morbid Clinical Trials

Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds

Start date: January 15, 2020
Phase: Phase 2
Study type: Interventional

The goal of this pilot study is to establish the feasibility and initial efficacy of the combination of phentermine and topiramate for adolescents and young adults who require additional risk reduction after bariatric surgery. This study will use a randomized, placebo-controlled, double-blinded design to evaluate an adjunctive 12-week intervention of phentermine + topiramate + standard of care vs. placebos + standard of care 6 months after bariatric surgery, among 12 to 24 year olds who don't achieve expected weight loss or who remain severely obese (n=10 total).

NCT ID: NCT04090840 Completed - Obesity Clinical Trials

Lifestyle Intervention Feasibility for Arrhythmia and Symptoms With Intermittent Fasting (LIFE AS IF)

LIFE AS IF
Start date: August 1, 2019
Phase: N/A
Study type: Interventional

BACKGROUND AND RATIONALE Two out of three Americans are overweight and obesity is associated with hypertension, sleep apnea, atrial fibrillation. Metabolic syndrome with centripetal obesity is also a precursor to insulin resistance and the development of Type II diabetes mellitus. While multiple strategies for weight reduction are often recommended in physician visits, calculating calories and energy expenditure is often inconvenient and does not promote compliance. Intermittent fasting, or time-restricted eating, is a methods to limit caloric intake by fasting for 16 hours to promote ketosis and suppress insulin secretion. Weight loss and reduction in body fat has been observed with brief periods of intervention as time-restricted eating results in reduction in overall caloric intake. Prospective feasibility studies and randomized comparative trials with intermittent fasting are lacking. The investigators recommend caloric restriction in all of our patients that suffer from arrhythmias and BMI >30. However, they have not systematically measured compliance and the efficacy of lifestyle interventions. Lifestyle counseling and weight loss has been shown to decrease the progression and burden of symptomatic atrial fibrillation. Intermittent fasting can result in consistent reductions in body fat and weight without specific lifestyle counseling. The aim of the present observation cohort study is to assess the feasibility of recommending intermittent fasting in an arrhythmia clinic with regard to compliance and efficacy. The investigators hypothesize that compliance and adherence to a 16/8 intermittent fasting regimen will be >25% and result in weight loss, compared to the 6 month trend prior to the intervention. This pilot study will serve as the basis to power the first randomized trial comparing intermittent fasting with other types of dietary counseling for arrhythmia outcomes. OBJECTIVES To prospectively assess compliance to prescribed intermittent fasting, measured by adherence and change in weight at 6 months.

NCT ID: NCT04073056 Completed - Morbid Obesity Clinical Trials

Efficacy Of Quadratus Lumborum II Block For Laparoscopic Sleeve Gastrectomy

Start date: August 1, 2018
Phase: Phase 4
Study type: Interventional

The QL 2 block is a novel fascial plane block recently described by Blanco and colleagues in which local anesthetic is deposited adjacent to the antero-lateral aspect of the quadratus lumborum muscle. This results in posterior spread of local anesthetic through the middle layer of the thoraco-lumbar fascia, which theoretically communicates with the paravertebral space resulting in potentially longer-lasting and denser analgesia than wound infiltration. The QL 2 block derives from the TAP block, which is also a fascial plane block that is commonly used to treat pain following surgery involving the anterior abdominal wall. However, the QL block's more posterior location has recently been shown to provide a longer lasting and more profound analgesic effect than the TAP block, possibly by communicating with the paravertebral space. Although the TAP has been shown to be effective in a variety of surgical procedures involving an anterior abdominal wall incision including laparoscopic bariatric surgery the QL 2 block has until now, not been studied in the context of bariatric surgery.

NCT ID: NCT04063488 Completed - Clinical trials for Congenital Leptin Deficiency (Disorder)

The Effects of Metreleptin in Congenital Leptin Deficiency

Start date: June 20, 2019
Phase:
Study type: Observational

This study has been designed to 1) provide access to metreleptin to the only two individuals in the US known to have congenital leptin deficiency (CLD) and 2) explore a variety of unanswered questions about leptin physiology in general and metreleptin therapy in CLD specifically. The primary study endpoints include the following measures: body composition, measures of hepatic steatosis, measures of insulin sensitivity, and measures of sleep architecture. Secondary study endpoints include assessment of clock gene expression, body temperature, thyroid function, gonadal function, cognitive function, eating behavior, physical activity, mood, quality of life, and body image.