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Autonomic Nervous System Function Following Bariatric Surgery

Purpose: In the proposed study, the investigators will explore three specific aims. First, the investigators will examine cross-sectionally the association of obesity on sympathetic, parasympathetic, and sympathetic/ parasympathetic nerve fiber balance. In addition, the investigators will determine the relationship of the ANS and osteocalcin. Osteocalcin will be measured before and after a mixed meal tolerance test. In the second specific aim, the investigators will prospectively follow-up these individuals (n=30) following bariatric surgery. The effect of weight loss on measures of the ANS and osteocalcin will be examined six months following surgery with participants serving as their own control, pre- and post-surgical intervention. Thirdly, the investigators will address whether the effect of weight loss on the ANS and osteocalcin differ between those who had a history of diabetes at baseline versus those with no history of diabetes.
Sponsor: Christiana Care Health Services
Collaborator: American Society for Metabolic and Bariatric Surgery
Information provided by: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT00948545

Effects of Bariatric Surgery on Insulin

Purpose: This study, conducted at the NIH Clinical Research Unit (CRU) at the Phoenix Indian Medical Center, will compare the effects of two methods of bariatric surgery, the adjustable BAND and Roux-en-Y gastric bypass, on insulin. Bariatric surgery is a treatment for achieving and maintaining weight loss. The study will look at how this surgery might improve how insulin (a hormone important for regulating blood sugar levels) is made and works in the body and the possible role of changes in other hormones produced by the gut (stomach and intestines).

People between 18 and 50 years of age who are scheduled to have either laparoscopic adjustable BAND or Roux-en-Y gastric bypass surgery may be eligible for this study. Candidates are screened 4 to 6 weeks before their surgery with a medical history, blood tests, and an oral glucose tolerance test for diabetes.
Participants spend four days at the CRU or two days overnight and an out-patient visit approximately 4 to 6 weeks before their surgery and again 3 to 6 weeks after their surgery. They return for a 4 to 6 hour visit at the CRU at six months, one and two years after surgery, and for half-day outpatient visits at three, four, and five years after surgery for the following procedures:
•    Blood and urine tests, including a pregnancy test for women (4-day and 2-day admissions and years, 3, 4, and 5)
•    DEXA, an x-ray scan to determine body fat content (4-day and 2-day admissions and years, 3, 4, and 5)
•    MRI scan to measure fat tissue in the abdomen (4-day and 2-day admissions and Years, 3, 4, and 5)
•    Intravenous (IV) glucose tolerance test for risk of obesity and diabetes. A sugar solution is given through a needle in a vein of one arm and blood samples are drawn through another needle in a vein in the other arm (4-day admissions)
•    Meal test to measure blood sugar and insulin and gut hormone levels after a meal. After an IV line is placed in an arm vein, the subject eats breakfast over 20 minutes. Blood samples are collected halfway through the meal, at the end of the meal, and at 15, 30, 60, 90, 120, and 180 minutes after completing the meal. Subjects fill out questionnaires on feelings of hunger and fullness before, during, and after the meal test (4-day and 2-day admissions)
•    Glucose clamp test to measure the effect on the body of insulin given through a vein. An I.V line is placed in a vein in the arm and in a vein of the hand on the other side of the body. While insulin is infused through one IV, blood sugar levels are checked every five minutes and a sugar solution is given into a vein as needed. A radioactive sugar is also infused very slowly over four hours to determine how much sugar the body produces by itself (4-day admissions)
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00535600

Prevention of Coronary Heart Disease in Morbidly Obese Patients (SphCor)

Purpose: The changes in risks of developing coronary heart disease in patients with morbid obesity after different weight loss interventions have not been extensively studied. The objective of this study is to investigate whether an intensive lifestyle intervention program in a tertiary care clinic (Spesialsykehuset for Rehabilitering) is comparable with bariatric surgery in decreasing the risk of cardiovascular disease in these patients.
Sponsor: The Hospital of Vestfold Collaborator: Rikshospitalet HF
Information provided by: The Hospital of Vestfold
ClinicalTrials.gov Identifier: NCT00626964

Oxygenation and Pulmonary Function in Morbidly Obese Patients Undergoing Bariatric Surgery

Purpose: This is a randomized controlled study in which patients with morbid obesity undergoing bariatric surgery will be recruited in the preoperative clinic. Patients will be randomized into two groups to receive oxygen with BoussignacTM continuous positive airway pressure (CPAP) or conventional Venturi mask postoperatively immediately after extubation. The objective of the study is to examine if BoussignacTM CPAP results in improved oxygenation versus Venturi face mask when it is applied immediately after extubation in patients with morbid obesity post bariatric surgery.
Sponsor: University Health Network, Toronto
Information provided by: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01002599

PET Imaging and Bariatric Surgery

Purpose: The purpose of this study is to look at certain areas of the brain that are related to addictive behaviors, such as overeating. These areas are called “dopamine type 2 receptors” (DRD2) and other studies have shown that people with obesity have less of these. We propose that low DRD2 availability seen in subjects with morbid obesity will change with weight loss associated with bariatric surgery.
Sponsor: Vanderbilt University
Information provided by: Vanderbilt University
ClinicalTrials.gov Identifier: NCT00801827

Effect of Macrocomposition on Nonalcoholic Fatty Liver Disease (NAFLD) in Bariatric Surgery Candidates

Purpose: Nonalcoholic liver disease (NAFLD) is known to be caused by deposition of fat in the liver. The impact of NAFLD on bariatric surgery is of great concern. Enlarged fatty livers increase the operative complications of bariatric surgery, and weight loss prior to bariatric surgery has been shown to reduce complications of surgery. Most bariatric surgery programs use a conventional low-fat, calorie-restricted diet during the preparation phase for surgery. The investigators will compare the effects of the low-carbohydrate versus the low-fat diets on weight loss, reduction in liver fat content, and liver size. These results will provide new clinical insights into the optimal dietary intervention to make bariatric surgery safe and effective for the increasing numbers of patients opting for this aggressive therapy for morbid obesity. Patients approved for bariatric surgery by the University of Michigan Bariatric Surgery multidisciplinary committee will be randomly assigned to either a 1000 to 1200 calorie low-fat or low carbohydrate, eight-week study diet. All the food for this study will be provided for free by the study team. Participants will be required to meet with the study team weekly to pick up study food and for a nutritional consult. These visits will occur in the eight weeks preceding the patient’s bariatric surgery procedure. During the bariatric surgery, a liver biopsy will be performed to assess the impact of the study diet on liver fat content.
Sponsor: University of Michigan Collaborator: National Institutes of Health (NIH)
Information provided by: University of Michigan
ClinicalTrials.gov Identifier: NCT00887393

Thromboprophylaxis and Bariatric Surgery

Purpose: This trial is an assessment of the efficacy of three thromboprophylaxis regimens in two types of bariatric surgery—gastric banding and gastric bypass—on anti-Xa activity levels.

The study includes two groups of 150 patients scheduled for gastric banding or gastric bypass.

Assessment of anti-Xa levels before and four hours after the injections from Day 0 to 2 in order to determine the best prophylactic regimen allowing expected values ranged between 0.3 and 0.5IU/mL.
Sponsor: University Hospital, Strasbourg, France
Collaborators: French State
Sanofi-Aventis
Information provided by: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00444652

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