Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of MBX 1416 in Healthy Subjects...
HealthyPostbariatric HypoglycemiaThe purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of MBX 1416 in healthy volunteers and patients with postbariatric hypoglycemia. This study includes 2 parts. Part A involves a single dose of MBX 1416 or placebo taken as a subcutaneous injection (SC). Part B involves repeat doses of MBX 1416 or placebo taken as a subcutaneous injection (SC).
Nurse Coaching the Effect of on Glycemic Control, Fear of Hypoglycemia and Risk Perception in Adults...
Nurse's RoleDiabetes Mellitus1 moreBecause of the unforeseen rate of increase in case numbers, the high rates of mortality and morbidity, and the increased socio economic load it causes, diabetes has become the most discussed chronic and widespread metabolic disease in Turkey, and throughout the World, there are focused efforts to find a solution. It is very important for a person to self-assesss and evaluate to draw a roadmap for improved outcomes in a disease with a high financial and moral burden. A nurse is not only a caregiver to patients, but also a person who guides them to increased engagement and motivation in the care of their illness. Integrative Nurse Coaching is gaining notoriaty as an effective method to improve patient engagament and motivation in self-responsibility for health. The Integrative Nurse Coach Academy in the USA carries out studies and trainings to further this improvement. With cooperation between United States and Turkish nurse colleagues, it aims to bring Integrative Nurse Coach practice to Turkey. The Integrative Nurse Coach uses the nursing process as a framework to guide nurse coaching practice. This requires a shift in traditional nursing terminology and meaning to understand and incorporate the patient's subjective experience as follows: from assessment to stablishing a relationship, identifying readiness for change and the resources available to the patient for change; from nursing diagnosis to identifying opportunities and issues; from outcomes to having the patient set the agenda for achievement of the patient's goals; from 3 planning to creating the structure of the coaching interaction; from intervention to empowering the patient to reach goals; and from evaluating to assisting the patient to determine the extent to which goals were achieved. The Theory of Integrative Nurse Coaching (TINC) , developed by the Integrative Nurse Coach Association , sheds light on this point. The TINC encompasses many holistic nursing theories and contains three concepts and five components. The three concepts are healing, metaparadigm in nursing theory (nurse, person, health, environment), and patterns of knowing in nursing (personal, empirics, aesthetics, ethical, not knowing, sociopolitical. The TINC five components include Integrative Nurse Coach Self-Development (self-reflection, self-assessment, self-evaluation self-care), Integral Perspective and Change, Integrative Lifestyle Health and Well-Being, Awareness and Choice, and Listening With Heart The five components all have equal value and form the basis for the nurse coach professional practice model. There is a parallel process of self-development for both the nurse coach and the client. The SelfDevelopment component empowers individuals (including the nurse coach) to focus on their health and wellness from an integral perspective and to identify their individual knowledge, expertise, strengths, and resources, while recognizing the fluidity of the change. The TINC is designed to guide nurse coaching practice, education, research, and health care policy. The theory emphasizes, describes, and directs the practice of nurse coaching, a recognized holistic nursing modality. It has been seen that the TINC framework is very suitable for individuals with diabetes to provide their own management.
Acute Changes in Plasma Glucose and Cardiovascular Disease in Diabetes
DiabetesHypoglycemia3 morePatients with diabetes have an increased risk of sudden cardiac death compared to the general population. Severe hypoglycemia is associated with an increased risk of cardiovascular (CV) disease (CVD) and events, including cardiac arrhythmias and sudden cardiac death; likewise, increased glycemic variability is associated with macrovascular complications and increased mortality. The physiological mechanisms linking hypoglycemia and glycemic variability to CVD and CV events remain unclear. Myocardial work and mechanical dyssynchrony will be measured by speckle tracking echocardiography during euglycemia, hypoglycemia and hyperglycemia in individuals with type 1 diabetes, type 2 diabetes, and without diabetes. Echocardiographic images from three experimental clamp studies - Hypo-Heart 1 (sub-study 1), Hypo-Heart 2 (sub-study 2) and Rapid-Heart - will be included in this study.
CREON for the Treatment of Post-RYGB Hypoglycemia
HypoglycemiaHypoglycemia is an increasingly recognized complication of Roux-en-Y gastric bypass (RYGB) that is poorly understood and difficult to treat. Investigators hypothesize that after RYGB some patients have incomplete carbohydrate absorption in the small intestine which leads to inconsistent glucose levels and hypoglycemia during oral consumption of a meal. Investigators further hypothesize that pancreatic enzyme supplementation with (Creon) during meals and snacks will improve carbohydrate absorption and lead to more stable glucose levels in patients with post-RYGB hypoglycemia.
T1 Diabetes Hypoglycemia Prevention Pilot
Diabetes MellitusType 11 moreA single center pilot study assessing the Vigilant Diabetes Management System for the prevention of recurrent mild to moderate hypoglycemia in type I diabetes patients.
Risk of Nocturnal Hypoglycemia and Arrhythmias With Sitagliptin Versus Glimepiride in Patients With...
Diabetes Mellitus Type 2This exploratory double blind randomized active controlled study is designed to assess the effects of a treatment with therapeutical dosage of sitagliptin versus therapeutical dosage of glimepiride as add on therapy in patients with diabetes mellitus type 2 (T2DM) patients inadequately controlled on metformin monotherapy.
Carvedilol in Treating Hypoglycemia Unawareness
Hypoglycemia UnawarenessType 1 diabetes mellitus (T1DM) can lead to cardiovascular, renal and neurological complications if left poorly-controlled over prolonged periods of time. However, lowering glycemic goals for diabetic patients increases their risk for hypoglycemia exposure. Hypoglycemia is associated with symptoms such as heart palpitations, fatigue, shakiness, anxiety, confusion, and blurred vision. Recurrent hypoglycemia leads to impairment of the body's autonomic and symptomatic responses to this condition, and can result in loss of awareness in the patient of the hypoglycemic state. Repeated incidences of hypoglycemia from loss of this awareness can result in even more hypoglycemic episodes and more severe outcomes, such as loss of consciousness, accidents, hospitalization and even death if left untreated. The aim of this study is to investigate whether adrenergic blockade through the use of low-dose carvedilol treatment can improve hypoglycemia awareness and the counterregulatory hormone responses to hypoglycemia in T1DM patients with impaired awareness of hypoglycemia.
Effect of ZT-01 on Glucagon During Hypoglycemia in Type 1 Diabetes Mellitus
Type 1 DiabetesHypoglycemiaThe purpose of this study is to determine whether ZT-01 increases the glucagon response to hypoglycemia in type 1 diabetes (T1D). ZT-01 is a specific somatostatin (SST) type 2 receptor antagonist hypothesized to increase the counterregulatory glucagon release during hypoglycemia, which is impaired in diabetes, and may thus reduce the occurrence of hypoglycemia. Approximately 25 participants with well-controlled type 1 diabetes will be recruited to a crossover study and be randomized to the order in which they receive a single administration of placebo, low dose and high dose ZT-01 during three euglycemic-hypoglycemic clamps 2 to 6 weeks apart, with a follow-up visit approximately 1 week after the final clamp. Participants will stay overnight in the clinic before each clamp, and their plasma glucose (PG) will be kept at euglycemic levels with IV insulin and dextrose as needed. The following morning, the clamp will begin and the subject's PG will be kept at 5.5 mmol/L (euglycemia) with variable IV insulin (and dextrose as needed). Study treatment will be administered during this euglycemic period, and then insulin will be increased so that PG falls to a plateau of mild hypoglycemia, and then increased further to clinically significant hypoglycemia. Release of glucagon and other counterregulatory hormones will be measured, and a symptom score will be completed, during euglycemia before and following study treatment, and during each level of hypoglycemia. Following the clamp, the participant's blood glucose will be returned to normal levels prior to leaving the clinic.
Raptiva and Sirolimus in Islet Transplantation for Type 1 Diabetes
Type 1 Diabetes MellitusHypoglycemiaThe primary objective of this protocol is to test the safety and efficacy of a treatment regimen consisting of maintenance therapy with efalizumab and sirolimus for 1 year followed by withdrawal of efalizumab and maintenance therapy with sirolimus, for the prevention of the destruction and rejection of islet transplants in type 1 diabetic recipients. Genentech, the manufacturer of efalizumab voluntarily withdrew the drug from the U.S. market in April of 2009. Previously transplanted subjects have been transitioned to alternative immunosuppressives and no new subjects will be transplanted under this protocol.
The Efficacy of Glucagon Like Peptide (GLP) - 1(7-36) Amide for Glycemic Control in Critically Ill...
Critically IllHypoglycemiaThe goal of this present proposal is to examine the efficacy of GLP-1 administered to control blood glucose in critically ill patients.