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Obesity, Morbid clinical trials

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NCT ID: NCT01536197 Completed - Morbid Obesity Clinical Trials

Taste Perception Pre and Post Bariatric Surgery

RBtaste
Start date: September 2009
Phase: N/A
Study type: Observational

The investigators wish to study the effects of three forms of bariatric surgery, gastric bypass lap banding, and sleeve gastrectomy. The surgery is not part of the clinical trial. If your insurance does not cover the procedure, then the patient is responsible for payment of the surgical process. The investigators are doing pre and post surgery testing to provide a better understanding of the effect of bariatric surgery-induced weight-loss on taste perception.

NCT ID: NCT01536002 Completed - Obesity, Morbid Clinical Trials

Pharmacokinetics of Propofol in Morbidly Obese Patients

Start date: June 7, 2011
Phase: Phase 4
Study type: Interventional

The objectives of this study are - To determine PK of propofol in bariatric patients - To identify the physiological variables that induce propofol PK changes in bariatric patients, when compared to a normal-weight population. - To define context-sensitive half-time profiles for propofol in bariatric patients.

NCT ID: NCT01525472 Completed - Morbid Obesity Clinical Trials

Accelerated Aging of the Cells of Visceral Adipose Tissue in Morbid Obese Subjects

SENAPID
Start date: February 13, 2012
Phase:
Study type: Observational

Numerous epidemiological studies clearly showed the relationship between the excessive growth of visceral adipose tissue and risk of developing insulin resistance, type 2 diabetes and other cardiovascular risk factors. However, the mechanisms contributing to the deleterious role of visceral adipose tissue remain to be elucidated. Several observations suggest that adipose tissue depots exhibit distinct metabolic and secretory capacities according to their locations. We have recently shown that visceral fat depots display higher immuno-inflammatory cells infiltration than that of subcutaneous fat. In addition, the endothelial cells of visceral compared to subcutaneous adipose tissues express a pro-inflammatory phenotype and several markers related to aging. Finally, we have shown that visceral adipocyte-derived secretions promote the endothelial cell senescence in an extent higher than subcutaneous adipocyte-derived products. These data suggest that senescence 1) might be a phenomenon related to the location and therefore the microenvironment of adipose tissue and 2) might be responsible for an abnormal activation of proinflammatory response, favouring the development of metabolic and secretory dysfunction of adipose tissue in obesity. Our working hypothesis, based on these observations, is that the visceral adipose tissue provides a microenvironment that promotes accelerated aging. This senescence may be responsible for the establishment of an inflammatory reaction, alteration of the metabolic activity and adipocyte differentiation capacity of progenitor cells leading to the development of obesity associated diseases. The proposed project is a descriptive cross-sectional pathophysiological study .The aims are 1) to better define the process of senescence in human adipose tissue, 2) to precise the mechanisms and 3) to analyse the cellular and functional consequences of aging on inflammation, adipose tissue development and metabolism. 200 morbidly obese candidates for bariatric surgery will be studied. The collection of clinical and laboratory data and the collection of biological samples (plasma, blood cells and subcutaneous and visceral adipose tissues) will be made at the inclusion and during surgery (obesity center, Hôpital Louis Mourier). Analyses of adipose tissue will be performed at INSERM U1048 and will focus on in vitro approaches of the cells of the adipose tissues (mature adipocytes, endothelial cells, progenitor cells and immuno-inflammatory cells). This project will permit to better understand the pathogenicity associated with the excessive growth of visceral adipose tissue and may reveal new therapeutic targets to limit obesity-associated pathologies.

NCT ID: NCT01519726 Completed - Morbid Obesity Clinical Trials

CYP3A4 Metabolism Before and After Surgery Induced Weight Loss Using Midazolam as Model Drug

MEMO
Start date: December 2011
Phase: Phase 4
Study type: Interventional

Before and during bariatric surgery patients are given oral and i.v. midazolam, respectively and blood samples are drawn to establish midazolam time-concentration profiles. After 0.5-2 years, and substantial weight loss, oral and i.v. midazolam are administered once more and blood samples are taken again.

NCT ID: NCT01518023 Completed - Colorectal Cancer Clinical Trials

Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy

Start date: January 2011
Phase: N/A
Study type: Observational

There is evidence that gastrointestinal operations for non weight-losing purposes are beneficial for diabetes mellitus. Aiming to analyze such hypothesis, patients submitted to gastric bypass for morbid obesity, gastrectomy for gastric cancer and colectomy for colo-rectal cancer will be compared. The end point will be changes in fasting blood glucose and hemoglobin A1c concentration.

NCT ID: NCT01514799 Completed - Weight Loss Clinical Trials

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

Start date: August 29, 2011
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT01504685 Completed - Morbid Obesity Clinical Trials

Long-Term Results of a Randomized Trial Comparing Banded-versus-Standard Laparoscopic Roux-en-Y Gastric Bypass

Start date: May 2003
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT01473186 Completed - Morbid Obesity Clinical Trials

Study of Menstrual Irregularities and Endometrial Pathology in Women Undergoing Bariatric Surgery

Start date: January 2011
Phase: N/A
Study type: Observational

Objectives: Given the profound impact of obesity on the genesis of endometrial cancer, this study proposes to prospectively evaluate the baseline prevalence of menstrual irregularities and endometrial pathology in morbidly obese women and discover risk stratification markers that can potentially identify the highest risk women who might benefit from targeted cancer prevention strategies in a future clinical trial. - Specific Aim 1: To assess the prevalence of menstrual irregularities and to correlate gynecologic and menstrual history with the perceived personal risk and severity of gynecologic cancers in a population of female bariatric surgery candidates. - Specific Aim 2: To determine the prevalence of endometrial hyperplasia and cancer in morbidly obese women undergoing bariatric surgery. - Specific Aim 3: To obtain adipose, endometrium, and blood samples (before and after) bariatric surgery to assess baseline hormone levels and adipocyte-derived factors and to correlate with presence of menstrual irregularities, endometrial hyperplasia or cancer, and with postsurgical weight changes. Methods: - Specific Aim 1: After informed consent is obtained, a survey and medical history of prospective bariatric surgery patients will be performed at the University of Virginia. - Specific Aim 2: For those women who undergo bariatric surgery, study investigators will perform endometrial biopsies at the time of bariatric surgery on participants to determine the status of the endometrial lining and the potential presence of endometrial cancer and its precursors. - Specific Aim 3: At the time of surgery, blood, adipose, and endometrial tissue samples will collected for evaluation of adipocyte-related factors and correlation with clinical endpoints. Blood will also be collected at 6 and 12 months after surgery. Anticipated results: This study will identify the prevalence and correlation of menstrual irregularities with endometrial abnormalities and cancer in morbidly obese women as well as define their perceived risk of developing cancer. Serum biomarkers in obese women with and without endometrial cancer/precancer would be evaluated for correlation and potential applicability for endometrial cancer screening in this high-risk population. Most importantly, this study may provide evidence as to whether screening (via endometrial biopsy or other serum markers) is warranted in asymptomatic, morbidly obese women and suggest potential preventive and risk reduction mechanisms.

NCT ID: NCT01447524 Completed - Clinical trials for Type 2 Diabetes Mellitus

Caloric Restriction and Insulin Secretion

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

Caloric restriction in obese diabetic patients quickly improves glucose control, independently from weight loss. However, the early effects of a very-low calorie diet (VLCD) on insulin sensitivity and insulin secretion in morbidly obese patients with type 2 diabetes are still unclear. The objective of this study was to investigate the relative contributions of insulin sensitivity and/or secretion to the improvement in glucose metabolism, after one week of caloric restriction, in severely obese diabetic patients. For this purpose, hyperglycemic clamps were performed in 14 severely obese (BMI> 40 kg/m2) patients with type 2 diabetes in good glucose control (HbA1c <7.5%), before and after 7 days on VLCD 400 kcal/day.

NCT ID: NCT01447316 Completed - Obesity, Morbid Clinical Trials

Bariatric Surgery on Short Term Weight Loss- Related Changes in Gait

Start date: August 2009
Phase: N/A
Study type: Observational

This is a short term study of the effects of bariatric surgery on body composition, gait parameters during walking, lower extremity joint pain and quality of life (QOL) in morbidly obese patients who are already scheduled for a bariatric surgical procedure.