13 Clinical Trials for Various Conditions
This is a randomized placebo controlled clinical trial designed to investigate the effects of micronized fenofibrate on fasting and postprandial lipoproteins, oxidized fatty acids and lipoproteins, inflammatory mediators and thrombotic factors among hypertriglyceridemic individuals with two or more other characteristics of the metabolic syndrome.
Subjects with hypertriglyceridemia and metabolic syndrome are being recruited and receive diet interventions with either a high-saturated fat diet or a low-fat high protein diet for 4 days (days 1-4) and a breakfast on day 5. Blood samples are collected on day 1 and day 5 to examine lipid levels and circulating monocyte phenotypes.
Approximately 24% of the US adult population meet criteria for metabolic syndrome (MetS), diagnosed by a combination of abdominal obesity, elevated blood pressure, high triglyceride and low HDL-cholesterol level, and pre-diabetes. MetS quintuples the risk of diabetes, and doubles the risk of cardiovascular disease (CVD), particularly heart failure. Lifestyle modification is the initial step of treatment, but few studies have demonstrated early and sustained efficacy in remission of MetS. Our preliminary studies of a lifestyle change program for patients with MetS included a 1-year of development of an intervention by an interdisciplinary team of experts in medicine and the behavioral sciences. The investigators then tested the efficacy of the intervention in a treatment-only, proof-of-concept study. The investigators achieved our goal of 50% MetS remission after 2 years, in a sample of 26 patients. This study is the second step of a research program testing an innovative bio-behavioral intervention aimed at remitting MetS through lifestyle intervention, by focusing on eating patterns, daily activity, and stress management. The overarching objective of this research program is to determine the efficacy of the ELM lifestyle intervention to achieve remission of MetS. This purpose of the current study is to prepare for a large, randomized, clinical trial by conducting a smaller clinical trial that examines the acceptability of the ELM intervention (ELM Group) as compared to two other intervention arms (ELM Classes, ELM Individual).
The purpose of this study is to determine the effectiveness of two different non-energy restricted controlled carbohydrate programs with the American Diabetes Associations' diet on glycosylated hemoglobin and other diabetes risk factors in obese adolescents with metabolic syndrome, a constellation of symptoms associated with the development of type 2 diabetes and cardiovascular disease.
Approximately 1/4 of the US population has insulin resistance and the associated risk factors such as elevated lipid levels -triglycerides (type of fat from what we eat and what the liver produces and low HDL cholesterol which is the good cholesterol helping to protect against heart disease. Currently one known treatment for this a medication called fenofibrate, another medication that can improve insulin resistance is rosiglitazone, a third treatment known to improve insulin resistance an decrease triglycerides is weight loss. In this study insulin resistant individuals with elevated triglycerides and or a ratio of triglycerides to HDL cholesterol of 3:1 or greater will be randomized (selected by chance) to receive one of these treatments and results of insulin sensitivity and cardiac risk profiles will be compared at the end of the study.
The overall goal of this project is to determine the inflammation lowering impact of anthocyanin-rich Aronia berries. Inflammation is an underlying mechanism driving the development of several diseases. While an elevation in immune signals in the systemic circulation is commonly attributed to adipose tissue, inflammation is not present in all obese individuals. Adipose tissue must become inflamed, and the inflammation trigger may come from other sources. Microorganisms (microbiome), host tissues, and immune cells residing in the gastrointestinal tract (GIT) are a key source of pro-inflammatory signals that may cause the host organism to become inflamed. Anthocyanins are bioactive compounds with established anti-inflammatory and microbiome altering properties. We hypothesize that the GIT microbiome is a key determinant of host inflammation than can be manipulated by anthocyanins-rich berries to lower inflammation. We assembled a cohort of individuals, characterized their GIT microbiome and performed anthropometric measurements, basal measures of metabolism and metabolic health, and triglyceridemic, metabolomic, and inflammation responses to a high-fat meal challenge.
The broad, long-term aims of this scope of work are to investigate the effects of the Pritikin Program to the general population. The study will test the effects on individuals from the community with dysfunctional lipids, blood pressure and glycemic control. To assess the effectiveness of the Pritikin Program in the community, the effects of Pritikin lifestyle intervention on overall health will be investigated.
This research study is being conducted to test the effects of two drugs on blood lipids (cholesterol and triglycerides) and blood sugar (glucose) levels in patients with diabetes or "pre-diabetes" (both of which have a condition called "insulin-resistance"). These products are Niaspan (extended release nicotinic acid) and Omacor (omega-3 acid ethyl esters). We hypothesize that the combination of Niaspan and Omacor will reduce serum triglyceride levels, increase HDL-cholesterol levels and do so without altering glucose levels.
In people with the metabolic syndrome, the investigators hypothesize that administration of a single 300 mg dose of a grape seed extract (GSE) will reduce insulin resistance (how well cells in the body can take up and use glucose), oxidative stress, and the amount of oxidized LDL in the blood during a 24 hour period. These measurements will be assessed at hourly intervals during the 24 hour study day protocol. Additionally, the investigators hypothesize that daily administration of 300 mg of GSE for 30 days will decrease baseline insulin resistance, oxidative stress, and the level of oxidized LDL in the blood.
Patients with metabolic syndrome, insulin resistance, and elevated triglycerides of 150 mg/dl or higher will be randomized to one of four groups: 1) placebo; 2) metformin; 3) fenofibrate; or 4) combined metformin and fenofibrate for a period of 12 weeks after titration to target dose. We are interested in the effects of these therapies on triglyceride levels, HDL-C, insulin resistance, and markers of inflammation.
The major purpose of this study is to examine the effect of two sources of dietary omega-3 fatty acids, each given at two doses, on potential health benefits related to cardiovascular disease prevention. The two sources of dietary omega-3 fatty acids will be fish oil, and flaxseed oil.
The Habitual Diet and Avocado Trial will evaluate the effects of providing one avocado per day for recommended consumption over a 6 month period in a cohort of approximately 1000 free-living participants with increased waist circumference in comparison with a control group that will maintain their habitual diets. Participants will be recruited and screened at 4 clinics in 4 locations: Pennsylvania State University; Loma Linda University; UCLA, and Tufts University (250 per site).
This study is researching an experimental drug called mibavademab. The study is focused on participants with GLD who have been on metreleptin treatment for at least 6 months with no change in dose for the last 3 months. The aim of the study is to see how safe and tolerable mibavademab is when switching from treatment with metreleptin. The study is looking at several other research questions, including: * What side effects may happen from taking mibavademab * How much mibavademab is in the blood at different times * Whether the body makes antibodies against mibavademab (which could make mibavademab less effective or could lead to side effects)