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Weight Loss clinical trials

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NCT ID: NCT00431925 Not yet recruiting - Clinical trials for Head and Neck Cancer

Can Cytokines Predict the Severity of Acute Mucositis and the Need for Gastrostomy Tubes (PEG)?

Start date: n/a
Phase: N/A
Study type: Observational

Mucositis and xerostomia are the most common complications of head and neck (H&N) irradiation, and the combination of chemotherapy and radiation therapy is associated with a significantly higher rate of complications. Mucositis usually develops during the second or third week of a course of standard radiotherapy, and the pain it causes peaks between the third and last week of treatment. The pain then persists for at least one month following the completion of therapy, and may be so overwhelming that it prevents patients from swallowing food and fluids. The patient is therefore at a risk to develop malnutrition, and must be treated vigorously. In this respect, the use of gastrostomy tubes (PEG) has been shown to be beneficial. Completion of the full course of irradiation, without interruption, is important for achieving best possible results in cancer of the H&N. It is therefore essential to identify and refer patients at risk to receive effective and timely nutritional intervention. Since mucositis represents a clinical continuum which differs between patients, it is difficult to assess before-hand which patients will be at risk. There is no simple laboratory tool available, which could predict which patients are susceptible to develop severe mucositis and dysphagia, and eventually will require a feeding gastrostomy. The first phase of mucositis, inflammation, results in the production of pro-inflammatory cytokines such as interleukin-1 (IL-1) and tumor necrosis factor-alpha (TNF-α). In general, the inflammatory cytokines IL-1, interleukin-6 (IL-6) and TNF-α are elevated in inflammatory conditions and are found in increased levels in blood and tissue fluid during inflammation, while anti-inflammatory cytokines are produced in a decreased manner. The main purpose of this study is to find the best indicators and prognosticators of mucositis occurring in the healthy oral tissues of H&N cancer patients receiving treatment, and to understand the cytokines balance mechanism of action. Assuming there is a correlation between high cytokines levels during inflammation and the severity of radiation induced mucositis, finding these prognostic factors may help us predict during the first part of the treatment the need for PEG, placing it prior to the complications associated with severe mucositis on one hand, and avoiding unnecessary procedures on the other hand.

NCT ID: NCT00421616 Not yet recruiting - Overweight Clinical Trials

Effectiveness of High Protein Diets in Promoting Weight Loss in Overweight and Obese Subjects.

Start date: February 2007
Phase: N/A
Study type: Interventional

Several studies have reported greater weight loss when following high meat-protein diets but limited studies have studied high plant-based protein diets. Thus we aim to investigate the effect of high protein diets in weight management and also to investigate the superior protein source in achieving this effect. In addition, we aim to develop dietary intervention strategies that are realistic and sustainable.

NCT ID: NCT00415974 Completed - Obesity Clinical Trials

PACE-PC: Primary Care Management of Adolescent Obesity

Start date: February 2008
Phase: N/A
Study type: Interventional

This 12-month randomized controlled trial, sponsored by NIH/NCI, aims to reduce BMI in obese adolescents (ages 11 -13) by intervening on physical activity and nutrition behaviors within primary care settings. PACE-PC is a theory-based stepped care program that enables pediatricians and primary care providers to intervene with obese adolescents to improve their anthropometric, metabolic, physiological, behavioral, and quality of life outcomes over a one-year period. The program integrates clinician counseling, health educator counseling, and phone and mail contact. It supports tailoring to the needs of obese adolescents and family members and promotes improved diet and physical activity behaviors, weight loss, and ultimately weight loss maintenance. Participants will be randomly assigned to the Enhanced Usual Care or the PACE-PC stepped care condition. The Enhanced Standard Care condition includes an initial visit and counseling by a physician, 3 visits with a health educator, and materials on how to improve weight related behaviors. The PACE-PC Stepped Care condition includes 3 steps (each lasting 4 months), with the first step being the most intensive: Step 1 includes: a physician visit, monthly health educator visits, biweekly phone counseling, and weekly dissemination of nutrition and physical activity information Step 2 includes: a health educator visits every other month, biweekly phone counseling, and weekly dissemination of nutrition and physical activity information Step 3 includes: monthly phone counseling and weekly dissemination of nutrition and physical activity information Participants randomized to the PACE-PC condition will be enrolled in Step 1 (the most intensive) for the first 4 months. Depending upon response at the end of Step 1, for the next 4 months adolescents will be triaged to Step 2 (less intensive) or will repeat Step 1. At 8 months, again based upon treatment response, triage will occur to either Step 3 (least intensive) or repetition of the previous step.

NCT ID: NCT00394667 Completed - Obesity Clinical Trials

Effect of Tesofensine on Weight Reduction in Patients With Obesity.

Start date: September 2006
Phase: Phase 2
Study type: Interventional

Purpose: To evaluate the efficacy on weight reduction, metabolic parameters and safety of tesofensine versus placebo in obese patients

NCT ID: NCT00394212 Terminated - Obesity Clinical Trials

Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass

Start date: November 2006
Phase: Phase 3
Study type: Interventional

It is estimated that up to 20% of patients who have Roux-en-Y Gastric Bypass (RYGB) surgery will not meet their weight loss goal, or may even regain some of the weight they initially lost. One possible explanation is that the opening between the stomach pouch and the intestine becomes stretched. If this opening becomes too wide, food may be able to pass from the stomach to the intestine too quickly - causing patients to feel less full after eating. For some patients, doctors may recommend additional invasive surgery to tighten the opening between the stomach pouch and the small intestine. Although this may help patients resume their weight loss, the risk of complications during a second surgical procedure is significantly higher than the risk during the original gastric bypass. The purpose of this study is to evaluate an incisionless procedure for patients who have either had inadequate weight loss or have regained weight following gastric bypass. The procedure is designed to tighten the opening between the stomach pouch and the small intestine, which may slow down the passage of food to help patients feel full longer after eating.

NCT ID: NCT00377026 Completed - Obesity Clinical Trials

FirstWIND: Weight Loss Interventions After Delivery

Start date: September 2006
Phase: N/A
Study type: Interventional

This a pilot intervention study in which postpartum women will be randomized to receive a 6-month postpartum weight loss intervention or usual care.

NCT ID: NCT00375492 Completed - Clinical trials for Type 2 Diabetes Mellitus

Effect on Weight Loss of Exenatide Versus Placebo

Start date: September 2006
Phase: Phase 3
Study type: Interventional

This trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo on weight loss. This trial will evaluate overweight and obese subjects with type 2 diabetes who have inadequate glycemic control with metformin, sulfonylurea, or metformin plus a sulfonylurea. Subjects will be treated with exenatide or placebo in addition to their current oral antidiabetes agent regimen and participate in a lifestyle modification program.

NCT ID: NCT00373971 Completed - Hip Fracture Clinical Trials

Preventing Loss of Weight, Fat Free Mass and Activities of Daily Living

Start date: November 1995
Phase: N/A
Study type: Interventional

Malnutrition of elder orthopaedic patients leads to weight loss and loss of fat free mass. Changes in the individual’s nutritional status and body composition may adversely affect the patient’s postoperative level of activity. Aim. Thus, the purpose of the present study is to report changes in postoperative weight, FFM and functions vital to daily living in a group of elder orthopaedic patients that were actively involved in their nutritional care during the hospital stay.

NCT ID: NCT00357344 Completed - Weight Loss Clinical Trials

Study of Effects From Gastric Bypass Weight Loss on Brain Tissue

Start date: May 24, 2006
Phase: N/A
Study type: Observational

This study will evaluate how large, intentional weight reduction affects the human brain and possible ways to reverse the changes associated with excess body weight. Subtle changes in some brain regions occur in people who are overweight. Such changes may involve the regulation of eating behavior, though it is not clear whether the changes were present before weight gain or are a consequence. Magnetic resonance imaging (MRI) will be used to study local structures of the brain. Patients ages 18 to 45 who are undergoing gastric bypass surgery and who are not pregnant or breastfeeding may be eligible for this study. A study group of lean participants will serve as controls. Patients will visit the Phoenix Indian Medical Center for about 3 days at a time for tests. They will have a medical examination, electrocardiogram, and tests of blood and urine. Questionnaires they will complete involve patients' moods and possible influence on eating behaviors, as well as food preferences. A taste test, smell test, and assessment of decision-making processes will be conducted. An oral glucose tolerance test involves a needle placed intravenously (IV) in the arm, for drawing blood after patients drink a sugar solution. The test takes about 3-1/2 hours, with six blood samples taken (about 2 tablespoons total). A meal test also includes use of an IV line. After patients consume a liquid meal, blood will be collected to analyze levels of blood sugar and hormones. For the DEXA scan, which measures body composition, patients will lie still while low-dose X-rays are used for 5 to 10 minutes. Urine will be collected for 1 whole day, to measure cortisol, a hormone. The MRI scan uses a strong magnetic field to obtain images of body organs and tissues. Patients having any metal in the body that may interfere with the scanning machine should not have this test. For the MRI procedure, patients will lie on a table that slides into the enclosed tunnel of the scanner and be asked to lie still. Patients will be able to communicate with the MRI staff at all times during the scan, and they may ask to be removed from the machine at any time.

NCT ID: NCT00352157 Completed - Weight Loss Clinical Trials

Effect of Revival Soy on Weight Loss and Skin, Hair, and Nails in Premenopausal Women

Start date: July 2006
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if dietary consumption of Revival Soy can improve the appearance of the skin, hair, and finger nails and support weight loss in overweight, premenopausal women.