Active clinical trials for "Obesity, Morbid"

The purpose of the study is comparatively analyze the advantages and disadvantages of banded versus unbanded laparoscopic Roux-en-Y gastric bypass (RYGB). The outcome variables of the general study included morbidity, maximal weight loss, and late weight regain.

Objectives: To evaluate the effects of the technique of Breath Stacking (BS) in the distribution of ventilation in the chest in women with morbid obesity. Methods: Randomized clinical trial, blinded, and controlled with 32 women (BMI ≥ 40kg/m2), separated into two groups: control (GC) with n = 16 and 41.94 ± 9.38 years and group Breath Stacking (GBS) , n = 16 and 40.38 ± 10.16 years. Optoelectronic plethysmography (POE) was used to assess lung ventilation. For the BS technique was used to mask the expiratory branch occluded and Wright spirometer. GBS held three techniques with an interval of three minutes. The GC used the same circuit without the occlusion of the expiratory branch. Results: GBS was found to be higher in the contribution of tidal volume (VT) into the chest circumference (p = 0.04) and decrease in abdominal compartment (p = 0.03), whereas the CG showed no difference in distribution. Spirometric variables: FEV1 (%), FVC (%), FEV1/FVC (%), VC and CI showed no difference before and after the technical BS and GBS in the GC. Conclusions: The technique BS altered the distribution pattern of regional ventilation, resulting in greater contribution in lung volume in the lower rib cage, corresponding to activity of the diaphragm, with redistribution of volume between compartments.

Super Obesity, i.e. a BMI above 50, is difficult to treat. Normal gastric bypass surgery is not always enough for proper weight control. Bypassing a longer segment of the gut may be more beneficial. Which part to bypass is not clear. The investigators want to compare the effects between preventing a 60 cm proximal (oral) portion of the jejunum from food contact with the effects when preventing a 200 cm part of the jejunum from contact with bile and pancreatic juice. Endpoints are quality of life, gastrointestinal function, and weight development.

Gastric bypass surgery is the gold standard in bariatric surgery and is a successful method to reduce weight in morbidly obese subjects. Patients qualified for gastric bypass surgery are routinely pre-treated with a low calorie diet in order to reduce liver volume and to facilitate the approach of the gastro-oesophageal junction. Pre-treatment with omega-3 fatty acids has similar effects on liver volume, but a prospective comparison of both treatments has not been performed yet. Morbidly obese patients respond differently to surgical stress, due to a number of factors. First, obesity is associated with a low-grade inflammatory state induced by an increased amount of macrophages in adipose tissue. This state is associated with higher levels of pro-inflammatory cytokines in serum and with a less adequate immune response to infections. Second, obesity is associated with an altered cortisol metabolism possibly related to adrenal insufficiency. This could play an important role in the altered response to surgical stress and postoperative complications in obese subjects. Third, obesity is associated with altered erythrocyte function, including decreased erythrocyte deformability and increased aggregation, factors contributing to an impaired microcirculation. This study has a number of different aims. First, we will compare pre-treatment with the standard low calorie diet with omega-3 fatty acids on liver volume in patients qualified for gastric bypass surgery because of morbid obesity. Second, we will investigate the effect of omega-3 fatty acids on immune function, the low-inflammatory state of adipose tissue, the stress response of obese subjects before and erythrocyte function. Third, we will investigate the effect of gastric bypass surgery by comparing values before surgery with values on the first postoperative day and 6 months after surgery regarding to immunological parameters, stress response and erythrocyte function.

This study is a pilot project to investigate any effect on these markers in conjunction with lifestyle changes / conservative treatment. Useful and significant information in this pilot project is intended to be used as background for further research on this issue in connection with a doctorate. What is the effect of two years of outpatient treatment for lifestyle change for weight markers, waist, BMI, HbA1c, HDL and LDL cholesterol, triglycerides and uric acid in adults with morbid obesity?

The purpose of this study is to collect data prospectively on the safety and efficacy of the Laparoscopic Gastric Plication operation for patients with Severe or Morbid Obesity. The 95% confidence interval for average percentage of weight loss and body mass index will be computed at 6 months, one year and then annually. Analysis of comorbid conditions changes, quality of life and adverse events will be performed. With 50 subjects in the study, limited power is expected and no formal hypothesis testing will be performed.

The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents.

Obesity and obesity-related diseases have reached epidemic proportions in Western countries (1-3). Laparoscopic-adjustable silicone gastric banding (LASGB) is a purely restrictive operation that determine effective weight loss without inducing malabsorption (4-6). However, also after LASGB body weight loss is almost invariably associated with Free Fat Mass (FFM) loss, and the relevance of the FFM contribution to total energy expenditure is well-known (7-8). Different endocrine axes are reported to affect FFM. We previously reported that low levels of DHEA-S, an adrenal steroid with controversial anti-adipogenic and anti-atherogenic effects, are increased after the massive and sustainable weight loss induced by LASGB in severely obese premenopausal women and correlated with the higher post-operative FFM (9-10). It is also well known that GH/IGF-I axis exerts relevant effects on FFM and that reduced GH levels might increase Fat Mass (FM) and reduce FFM (11,12). Morbidly obese patients have a reduced GH secretion, generally reversible after weight loss (13-14). In a recent study currently in press, we reported that a persistent deficiency in the GH/IGF-I axis in very obese females is associated to lower decrease in FM after LASGB. Low IGF-I plasma levels have also been reported to be independent prognostic factors of liver steatosis and non-alcoholic steatohepatitis in morbidly obese patients (15) and ultrasound- measured hepatic left lobe volume might represent a reliable tool for the evaluation of liver involvement in obesity (16). GH deficiency (GHD) in adult patients is associated with an increase in FM and a parallel decrease in FFM (17). The severity of GDH is correlated to cardiovascular risk, body composition abnormalities and bone loss, and decreased left ventricular ejection fraction (18-20). GH therapy has been demonstrated to be effective in normalizing body composition, with beneficial effects up to a 2-years follow-up period (21-24). GH therapy has also been reported to be effective in sparing FFM during weight loss in obese patients and metabolic syndrome (25,26). However, these studies have some limitations due to the duration of the treatment and the lack of a preliminary evaluation of the GH/IGF-I axis secretory status in obese patients before the GH therapy. At present there are no data on the evaluation of the GH/IGF-I status before and after bariatric surgery and the effectiveness of recombinant GH treatment in very severe obese patients.

The purpose of the study is to evaluate the long term safety of the Swedish Adjustable Gastric Band (SAGB) in subjects with an SAGB in place. Specifically it is designed to determine the re-operation rate (band revision, band replacement and explants resulting from serious adverse device-related event {SADE}) of gastric banding at 4 and 5 year post implant.

The purpose of the trial is to determine whether a preoperative lifestyle intervention (targeting diet, exercise, and preparation for surgery) will favorably impact obesity-related parameters prior to bariatric surgery and improve short-term postoperative outcomes.