View clinical trials related to Type 2 Diabetes.
Filter by:The rapid rise in obesity (body mass index (BMI) ≥ 30 kg/m2) in the US over the past decade is responsible for more disease and death than any other single factor. Severe obesity is associated with numerous co-morbidities contributing to increased mortality risk, including end stage liver disease. Liver transplantation is a life-saving procedure for patients with end stage liver disease and obesity is becoming increasingly prevalent in this population. In one study, 54% of patients undergoing orthotopic liver transplant (OLT) were either overweight or obese [body mass index (BMI) >25 kg/m2], and 7% were severely or morbidly obese (BMI > 35 kg/m2). In addition, weight gain after solid organ transplantation is common because of steroid-containing immunosuppression and physical inactivity from decreased exercise tolerance. Obesity has been shown to increase the surgical morbidity, including wound infections, wound dehiscence, and hernias after transplantation. More significantly, excess pretransplant body weight hinders the rate of improvement in health-related quality of life after liver transplantation[7]. One possible approach for treating obesity after a liver transplant is to use bariatric surgery. Currently, bariatric surgery is established as the most effective means for both weight loss and resolution of metabolic disease in the morbidly obese. Recent publications emphasize the usefulness of bariatric surgery in the reduction of long-term cardiometabolic risk, cardiovascular disease incidence and mortality, and the management of uncontrolled type 2 diabetes (T2DM). In addition, it decreases mortality and improves both social functioning and quality of life. Bariatric surgery may improve eligibility for transplant in patients previously excluded due to excessive weight. Bariatric procedures, such as sleeve gastrectomy, allow for significant weight loss over time that greatly reduces or eliminates obesity related illnesses such as diabetes, high blood pressure and liver disease. According to the National Institutes of Health, bariatric surgery is reserved for patients with a BMI of > 40 or > 35 kg/m2 in the presence of major co-morbidities (e.g. type 2 diabetes, hypertension, sleep apnea, heart disease, etc). A significant number of liver transplant candidates have obesity-related illnesses, thus putting them at risk for cardiovascular and metabolic complications post-transplant. In addition, patients awaiting OLT are typically no longer medically stable to undergo intensive diet and exercise regimens as treatment for their diseases. Finally, decreased activity and medications used to prevent liver graft rejection all contribute to increased weight gain following transplant. In fact, in a series of 320 non-obese liver transplant recipients, 21.6% of patients became obese within two years of transplant. These comorbidities also contribute to poorer post-transplant outcomes and development of what is known as the post-transplant metabolic syndrome. Morbidly obese patients (BMI > 40 kg/m2) may also have higher frequencies of morbidities such as prolonged hospitalization and readmission as well as infectious, wound, and cardiovascular complications after transplantation. Finally, intra-abdominal adiposity creates a technically more challenging operative dissection, but no data exist on whether it increases perioperative morbidity or mortality in liver transplant patients. Sleeve gastrectomy is the most attractive restrictive procedure in a liver transplant population for several key reasons. One, sleeve gastrectomy does not require the implantation of a foreign body, such as placement of an adjustable gastric band, which in an immunocompromised post-transplant patient raises concern for severe infectious complications. Secondly, as stated previously, sleeve gastrectomy is a purely restrictive procedure, and therefore is least likely to cause significant macronutrient and micronutrient deficiencies. Finally, when compared to other restrictive procedures, such as adjustable gastric band placement, it has a lower likelihood of treatment failure (i.e. <50% excess weight loss). In fact, recent reports describe not only high failure rates with adjustable gastric band placement, but also high reintervention rates for both band-related complications (e.g. band erosion, leakage, slippage, port infection and esophageal dilatation) and failure to lose weight such that as few as 54% of patients may have their band in place after 10 years.
African Americans are twice as likely to have diabetes compared to their White counterparts and experience higher rates of diabetes-related complications. Diabetes-related health disparities underscore the need for effective, culturally tailored approaches to promote and sustain diabetes self-management over time. Diabetes self-management education (DSME) is effective in improving diabetes outcomes in the short-term. However, many adults with diabetes cannot sustain achieved improvements without continued follow-up and support. The 2012 revisions of both the National Standards for Diabetes Care 6 and the National Standards for DSME and Support emphasize the importance of providing both initial DSME and on-going diabetes self-management support (DSMS) to assist people with diabetes in maintaining effective self-management throughout a lifetime. While a great deal is understood about how to provide effective, initial DSME, less is known about who, where, when, and how to provide effective, sustained DSMS. One significant challenge is that DSME is a covered benefit in the healthcare system, while DSMS is not. This ultimately limits access and availability of DSMS programs, especially for low-income African Americans. Accordingly, there is critical need to develop, evaluate, and understand effective DSMS models that are ongoing, patient-driven, and embedded in the community.
Accumulating evidence suggests that bile acids and bacteria in our intestines may constitute essential components in the complex mechanisms regulating gut hormone secretion and glucose homeostasis. At the same time, bile acids and gut bacteria are interdependent. Thus, it is likely that modification of the enterohepatic circulation of bile acids can lead to changes in gut hormone secretion or gut bacteria composition and consequently affect glucose homeostasis. The current study is a human interventional study with 7-day ingestion of a bile acid sequestrant or placebo, preceded and followed by meal tests and faecal sampling. The aim is to examine how (and if) bile acid sequestration can influence postprandial glucagon-like peptide-1 (GLP-1) secretion, gut microbiota and glucose homeostasis in patients with type 2 diabetes and healthy individuals. As a tool to sequester bile acids we will use sevelamer, a phosphate binding resin used in the treatment of hyperphosphataemia in adult patients with chronic kidney disease. Surprisingly, sevelamer was recently shown to improve glycaemic control in patients with chronic kidney disease and type 2 diabetes. The investigators hypothesize that higher luminal concentrations of bile acids in the distal gut will elicit changes in the postprandial gut hormone secretion and gut bacteria composition. The current study will help to clarify this hypothesis and improve our general understanding of the association between bile acid circulation and signalling, gut hormone secretion, gut bacteria and glucose metabolism.
Primary Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination to insulin glargine in HbA1c change from baseline to week 30. Secondary Objective: To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio combination to insulin glargine (with or without metformin) over a 30 week treatment period in patients with type 2 diabetes
Primary Objective: To compare the insulin glargine/lixisenatide fixed ratio combination to lixisenatide alone and to insulin glargine alone (on top of metformin treatment) in HbA1c change from baseline to week 30. Secondary Objective: To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio combination to insulin glargine alone and to lixisenatide alone (on top of metformin treatment) over a 30 week treatment period in patients with type 2 diabetes
The purpose of this study is to determine the optimal dose or doses of HM11260C, when administered once a week under the skin, to improve the control of blood sugar levels in patients with early-stage type 2 diabetes mellitus (T2DM).
The purpose of this study is to see if it is safe and effective to give alpha lipoic acid in people with cardiac autonomic neuropathy(CAN). Cardiac autonomic neuropathy(CAN) affects the nerves that control heart rate and blood flow to the heart in people with diabetes. CAN may cause problems with the rhythm of the heartbeat or decrease blood flow to the heart.
We propose a prospective, randomized, single-blind controlled crossover study to assess the effects of daily egg inclusion versus egg exclusion, on glycemic control, anthropometric measures, and overall diet quality in adults with Type 2 diabetes.
Our primary hypothesis is that bile acid sequestrant colesevelam and the antidiabetic drug metformin potentiates the secretion of the gut hormone glucagon-like peptide 1 (GLP-1).
Glucagon-like-peptide-1 (GLP-1) analogues are a new treatment for type 2 diabetes, which have recently been shown to have beneficial effects on weight, glycaemic control and postprandial triglyceride concentrations. Postprandial hypertriglyceridaemia, which is associated with an increased risk of cardiovascular disease, is a feature of type 2 diabetes. Hypertriglyceridaemia is due to excess triglyceride-rich lipoproteins (TRL) which consist of very low-density lipoproteins, (VLDL) synthesised by the liver which contain the higher molecular weight form of apolipoproteinB (apoB), apoB-100, and chylomicrons which are synthesised in the intestine in response to an intake of dietary fat and contain the lower molecular weight form of apoB, apoB-48. A recent study has shown that GLP-1 receptor signalling is required for the control of postprandial lipoprotein synthesis and secretion in hamsters and mice. GLP-1 was shown to reduce apoB-48 TRL production while a GLP-1 receptor antagonist increased apoB-48 TRL production. This study will investigate the effect of the GLP-1 analogue lixisenatide compared with placebo, in a double blind crossover study, on postprandial triglyceride metabolism in 12 patients with type 2 diabetes. Chylomicron and VLDL production and clearance rates will be measured in a repeated meal study by labelling apoB-100 and apoB-48 and by labelling triglycerides using stable isotope methodology. Glucose flux in response to a mixed fluid meal will also be investigated using stable isotope methodology. Gastric emptying and post heparin LPL activity will be measured. The hypothesis is that i] lixisenatide will lower postprandial glycaemia due to a decrease in endogenous glucose output and an increase in glucose clearance by peripheral tissues as a result of an improvement in insulin sensitivity.