13 Clinical Trials for Various Conditions
This trial studied different combinations of cash assistance to families that live in food insecure areas of Somalia and aimed to understand if this cash assistance provided reduced malnutrition of children and mothers.
The goals of this study are to find out if fat wasting and weight loss in the arms and legs of HIV patients taking highly active antiretroviral therapy (HAART) are caused by nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) and if wasting can be reversed if the NRTI is stopped and replaced with other anti-HIV drugs.
This is a pilot study to assess the safety, pharmacokinetics and effectiveness of PINTA 745 or placebo in treating protein energy wasting (PEW) in patients receiving maintenance hemodialysis (MHD).
Weight loss commonly occurs in patients with COPD, negatively influencing their quality of life, treatment response and survival. Loss of muscle protein is generally a central component of this weight loss and independently increases mortality. This study will provide relevant clinical information in regards to the anabolic properties of specific dietary substrates and their co-active anabolic effects. Hypotheses: 1) That supplementation of a hydrolyzed casein-based protein meal with the addition of carbohydrates is more anabolic than a hydrolyzed casein-based protein meal without carbohydrates in COPD patients and healthy older adults; 2) That leucine addition to a hydrolyzed casein-based protein meal only enhances the protein anabolic response in COPD patients and healthy older adults when carbohydrates are not added to the protein meal; 3) That COPD patients have a more efficient protein anabolic response to a hydrolyzed casein-based protein meal than healthy older adults. A fifth study day was added to measure protein requirements of included individuals to be able to interpret their response to the other interventions on the other study days, and to test the hypothesis that subjects with lower protein requirements respond less to intervention with leucine and/or carbohydrates. For the 5th additional test day we will first approach the 10 COPD and 10 healthy subjects who already completed the first 4 study days (and signed the re-contact form) to come back for this extra test day. We will (pre-)screen these subjects by phone for eligibility and check for changes in their recent medical history (with help of the (pre-)screening questionnaires in CRF). If all inclusion criteria are still met, these subjects will be asked to provide a written re-consent. If necessary, we will recruit new subjects who will complete only one of the four test days (i.e. the test day on which the hydrolyzed casein-based protein meal with carbohydrates is provided) and the additional 5th study day.
This study will assess the pharmacodynamics, pharmacokinetics, safety and tolerability of BYM338 in patients with COPD and cachexia. The primary outcome will be a change in thigh muscle volume compared to placebo. The study will last for approximately 24 weeks.
Loss of muscle protein is generally a central component of weight loss in Chronic Obstructive Pulmonary Disease (COPD) patients. Gains in muscle mass are difficult to achieve in COPD unless specific metabolic abnormalities are targeted. The investigators recently observed that alterations in protein metabolism are present in normal weight COPD patients. Elevated levels of protein synthesis and breakdown rates were found in this COPD group indicating that alterations are already present before muscle wasting occurs. The investigators recently observed that in order to enhance protein anabolism, manipulation of the composition of proteins and amino acids in nutrition is required in normal-weight COPD. Intake of casein protein resulted into significant protein anabolism in these patients. The anabolic response to casein protein was even higher than after whey protein intake. A substantial number of COPD patients, underweight as well as normal weight to obese, is characterized by an increased inflammatory response. This group failed to respond to nutritional therapy. Previous experimental research and clinical studies in cachectic conditions (mostly malignancy) indicate that polyunsaturated fatty acids (PUFA) are able to attenuate protein degradation by improving the anabolic response to feeding and by decreasing the acute phase response. Eicosapentaenoic acid (EPA) (in combination with docosahexaenoic acid (DHA)) has been shown to effectively inhibit weight loss in several disease states, however weight and muscle mass gain was not present or minimal. Until now, limited research has been done examining muscle protein metabolism and the response to EPA and DHA supplementation in patients with COPD. It is the investigator's hypothesis that supplementation of 2g/day EPA+DHA in COPD patients during 4 consecutive weeks will increase the muscle anabolic response to a high quality protein supplement as compared to a placebo, and supplementation of 3.5g/day EPA+DHA will increase the anabolic response even further. In the present study both the acute and chronic effects of EPA+DHA versus a placebo on muscle and whole body protein metabolism will be examined. The principal endpoint will be the extent of stimulation of net fractional muscle protein synthesis as this is the principal mechanism by which the effect of EPA+DHA on muscle anabolism can be measured. The endpoint will be assessed by isotope methodology which is thought to be the reference method.
In the United States, African Americans are 3.6 time and Hispanics 1.5 times more likely to suffer from chronic kidney disease and need dialysis treatment for life, when compared to the non-Hispanic Whites. Unfortunately many dialysis patients die, so that after 5 years only less than 35% are still alive. Dialysis patients who appear malnourished or who have muscle and fat wasting are even more likely to die. Interestingly, among dialysis patients, minorities (African Americans, Hispanics and Asian Americans) usually survive longer than the non-Hispanic Whites. If the investigators can discover the reasons for these so-called "racial survival disparities" of dialysis patients, the investigators may be able to improve survival for all dialysis patients and maybe even for many other people who suffer from other chronic diseases. During this 5 year study the investigators would like to test if a different nutrition and diet can explain better survival of minority dialysis patients. The investigators will also test if in additional to nutrition there are 2 other reasons for better survival of minority dialysis patients, namely differences in bone and minerals and differences in social and psychological and mental health. The investigators plan to study 450 hemodialysis patients every 6 months in several dialysis clinics in Los Angeles South Bay area. These subjects will include 30% African Americans, 30% Hispanics, 30% non-Hispanic Whites and 10% Asians. Every 6 months the investigators will examine their nutritional conditions, dietary intake, psycho-social conditions and quality of life, and will recruit 75 new subjects to replace those who left our study as a result of kidney transplantation, death or other reasons. Hence, the investigators estimate studying a total of 1,050 hemodialysis patients over 5 years. Clinical events such as hospital admissions and survival will be followed. Blood samples will be obtained every 6 months for measurements of hormones and "biomarkers", and the remainder of the blood will be stored in freezers for future measurements. The investigators plan to design and develop race and ethnicity specific nutritional risk scores and food questionnaires and will test some of these scores in larger national databases of hemodialysis patients. Almost a year after the study starts, the investigators also plan to do additional tests of body composition and dietary intake in a smaller group of these patients at the GCRC.
To obtain data on the safety of administering megestrol acetate and dronabinol as single agents or in combination to patients with human immunodeficiency virus (HIV)-wasting syndrome. To obtain preliminary data on the efficacy of single agent and combination therapy with megestrol acetate and dronabinol with regard to weight gain, appetite increase and quality of life in this patient population. To obtain steady-state pharmacokinetics data when megestrol acetate and dronabinol are administered as single agents and in combination. HIV-wasting syndrome, which is characterized by severely debilitating anorexia and weight loss, is of particular concern because it can exacerbate the primary illness and is associated with a poor prognosis. Attempts at maintaining body mass through the use of megestrol acetate and dronabinol, two anti-cachectic drugs, may prolong survival.
Individuals with chronic liver disease develop significant muscle wasting that remains post-liver transplant. The transplant surgery additionally challenges respiratory mechanics. Respiratory muscle strength has been measured to be impaired in individuals post liver transplant. This study proposes an 8 week intervention designed to increase respiratory muscle strength and pulmonary function that we hypothesize will correlate to improved functional performance and quality of life post-liver transplant. Pre-test post-test design, that will randomize subjects into an experimental group that will receive the inspiratory muscle strengthening exercise in addition to usual post-liver transplant care and a control group that will only receive the usual post-transplant care. Up to 50 subjects will be recruited from the Post-Liver Transplant Outpatient Clinic at the Miami Transplant Institute. The subjects will have repeated measurements of respiratory muscle strength, pulmonary function, functional mobility performance, and quality of life at baseline, 4 weeks, and 8 weeks.
There is a rising incidence of kidney failure in the US, with poor outcomes and high cost. End-stage renal disease (ESRD) affects almost 375,000 individuals in the US at a cost of more than $14 billion per year. Despite advances in dialysis and transplantation therapies, kidney failure leads to poor outcomes, poor prognosis and high health care costs. Malnutrition and the underlying systemic inflammatory response developed during the course of chronic kidney disease, worsen during ESRD, and lead to adverse outcomes, increased morbidity and mortality. Muscle wasting, impaired functional capacity and poor quality of life are the most important factors associated with malnutrition and inflammation in renal failure. We have shown in pre dialysis patients with moderate chronic renal insufficiency that the anabolic effects of resistance exercise training result in significant improvements in protein utilization, nutritional status and functional capacity even in the context of anorexia and prescribed low protein diets. Therefore, we propose to develop, test and implement a progressive resistance exercise routine for ESRD patients during the hemodialysis session. By implementing such intervention, we hope to offer a therapeutic strategy that can be incorporated to the standard of care of ESRD patients by working in conjunction with the dialysis unit staff.
This is a global, prospective, multi-center study that is designed to assess the long-term safety and efficacy of OAV101 in patients who participated in an OAV101 clinical trial. The assessments of safety and efficacy in Study COAV101A12308 will continue for 5 years after enrollment in this study.
Resistance strengthening exercise will increase strength and functional activity greater than ambulation in subjects post-liver transplantation.
We are testing the safety and efficacy of a 16-wk yoga lifestyle intervention on oral glucose tolerance, fasting lipid/lipoprotein levels, body composition, cardiovascular function, quality of life, CD4+ T-cell counts and viral load in HIV-infected men and women with components of The Metabolic Syndrome. We hypothesize that a yoga lifestyle intervention will improve metabolic, anthropometric, cardiovascular disease parameters, and quality of life domains without adversely affecting immune or virologic status in people living with HIV.