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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT01423266 Completed - Heart Failure Clinical Trials

Effects of a High Protein Diet on Clinical Outcomes in Heart Failure

Start date: December 2009
Phase: N/A
Study type: Interventional

This research project was designed to study the role of dietary modifications in heart failure (HF) patients that suffer from type 2 diabetes mellitus and obesity. Specifically, the purpose of this study is to determine whether or not heart failure patients participating in a 3-month intensive lifestyle modification program of either a high protein (30 % of total calories from protein) group will have a significant improvement in weight reduction, quality of life and clinical outcomes compared to a standardized protein (15% of total calories from protein) group.

NCT ID: NCT01422876 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients

Start date: August 2011
Phase: Phase 3
Study type: Interventional

This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.

NCT ID: NCT01422668 Completed - Diabetes Mellitus Clinical Trials

Effect of Coffee Consumption on the Glycemic Index of Khalas Dates Tested in Healthy and Diabetic Subjects

Start date: March 2010
Phase: Phase 3
Study type: Interventional

The aim of this study was to evaluate the composition of Khalas, a very common type of dates used in the UAE and to determine the effects of drinking Arabic coffee on the results of GI tests in both healthy and diabetic subjects.

NCT ID: NCT01421459 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study in Adults With Type 2 Diabetes

ELEMENT 2
Start date: September 2011
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus in controlling blood sugar levels in combination with two or more oral diabetes medications.

NCT ID: NCT01421147 Completed - Clinical trials for Diabetes Mellitus, Type 1

A Study in Adults With Type 1 Diabetes

ELEMENT 1
Start date: August 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus when taken once daily in combination with insulin lispro before meals three times a day.

NCT ID: NCT01420497 Completed - Healthy Clinical Trials

Systemic Effects of Epidural Methylprednisolone Injection on Glucose Tolerance in Diabetic Patients

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

Several studies have shown that in diabetic patients, the glycemic profile was disturbed after intra-articular injection of corticosteroids. Little is known about the impact of epidural injection in such patients. The goal of this study was double, at first comparing the glycaemic profile in diabetic patients after a unique injection of 80 mg of acetate methylprednisolone either intra-articular or epidural, secondly to compare the amount of systemic diffusion of the drug the after both procedures.

NCT ID: NCT01420016 Completed - Hypertension Clinical Trials

Prioritized Clinical Decision Support (CDS) to Reduce Cardiovascular Risk

Start date: August 20, 2012
Phase: N/A
Study type: Interventional

The objective of this project is to develop and implement sophisticated point-of-care Electronic Health Record (EHR)-based clinical decision support that (a) identifies and (b) prioritizes all available evidence-based treatment options to reduce a given patient's cardiovascular risk (CVR). After developing the EHR-based decision support intervention, the investigators will test its impact on CVR, the components of CVR, in a group randomized trial that includes 18 primary care clinics, 60 primary care physicians, and 18,000 adults with moderate or high CVR. This approach, if successful, will (a) improve chronic disease outcomes and reduce CVR for about 35% of the U.S. adult population, (b) maximize the clinical return on the massive investments that are increasingly being made in sophisticated outpatient EHR systems, and (c) provide a model for how to use EHR technology support to deliver "personalized medicine" in primary care settings

NCT ID: NCT01419652 Completed - Clinical trials for Coronary Artery Disease

Periprocedural Glycemic Control in Patients Undergoing Coronary Angiography

Start date: July 2009
Phase: Phase 4
Study type: Interventional

There are 24 million people with diabetes mellitus (DM) in the United States. Over one-third of patients presenting for coronary angiography have known DM, and an additional 20% of patients without known DM present with hyperglycemia on the day of coronary angiography. Hyperglycemia in the setting of urgent and elective percutaneous coronary intervention (PCI) is associated with a 40% relative increase in long-term mortality regardless of diabetic status. Mechanisms linking periprocedural hyperglycemia to adverse outcomes are poorly understood and the effects of treatment are unknown. This is a pilot study aimed at determining the effectiveness, feasibility and safety of continuing long-acting hypoglycemic medications on the morning of coronary angiography. Since hyperglycemia may cause increased platelet reactivity, a secondary aim is to evaluate a possible mechanism of benefit of periprocedural glycemic control on platelet activity. Patients with DM on hypoglycemic medications undergoing coronary angiography will be randomized to either continue or hold their clinically-prescribed long-acting hypoglycemic medications on the day of procedure. Patients with and without DM will be randomized to either routine care or additional glycemic control with the Yale insulin infusion protocol for 6 hours post-PCI. The primary endpoint of this study will be mean blood glucose level at the time of arterial access in the hold versus continue groups. Secondary endpoints will be mean blood glucose level at 6 hours post-PCI in the Yale versus routine care groups and number of hypoglycemic events in the glycemic control versus no glycemic control groups. The exploratory analysis assessing the effect of glycemic control on platelet activity will guide further studies evaluating the translation of an individual's platelet phenotype to the clinical risk of increased long-term mortality following PCI. The outcomes for this study (glucose levels and platelet function) are all measured during the hospital stay which averages 1 day.

NCT ID: NCT01419535 Completed - Diabetes Clinical Trials

Mifepristone Effects on Glucose Intolerance in Obese/Overweight Adults

Start date: November 29, 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - Metabolic syndrome is a name given to a group of factors that tend to occur together. These risk factors include central obesity (extra weight around the middle of the body) and high blood pressure and blood sugar levels. They also include low levels of HDL ("good cholesterol") and high triglyceride levels. A person is said to have metabolic syndrome if they have three or more of the above risk factors. People with metabolic syndrome are at increased risk for type 2 diabetes, stroke, and heart disease. - Cortisol, a hormone produced by the adrenal glands, is an important regulator of metabolism. People with central obesity and metabolic syndrome may have higher than normal cortisol levels that the body cannot regulate properly. Abnormal cortisol levels may play an important role in metabolic syndrome. Mifepristone is a drug that blocks cortisol. Researchers are interested in studying its effects on metabolic syndrome. Objectives: - To study the effects of short-term mifepristone treatment for metabolic syndrome. Eligibility: - Men and Women between 35 and 70 years of age are overweight or obese, and have abnormal glucose and triglyceride levels. Design: - Participants will be screened with a physical exam and medical history. They will also have blood and urine tests. - Participants will be admitted to the metabolic unit at the National Institutes of Health Clinical Center for the first 3 days of the study: - Day 1: Body measurements (height, weight, waist, hip, and neck) and blood pressure tests. Also, 24 hours of regular blood draws and 24-hour urine collection to monitor regular daily cortisol levels. - Day 2: Glucose/insulin infusion test to measure blood sugar levels. - Day 3: Infusion of cortisol-like compounds and then regular blood draws for about 3 hours to evaluate how cortisol is metabolized. - At the end of Day 3, participants will receive mifepristone or a look-alike capsule to take for 7 days at home. - After 7 days, participants will return to the metabolic unit to repeat the Day 1 and Day 2 study procedures. They will continue to take mifepristone. - One week after the second set of study tests, participants will return for a brief physical exam and blood tests. - The study procedures will be repeated after 6 to 8 weeks, with the other study drug.

NCT ID: NCT01418716 Completed - Hypertension Clinical Trials

TRANSforming InTerprofessional Cardiovascular Prevention in Primary Care

TRANSIT
Start date: April 2011
Phase: N/A
Study type: Interventional

The TRANSIT program is a program to TRANSform InTerprofessional clinical practices to improve cardiovascular prevention in primary care. It addresses priorities in primary care relevant to the Chronic Care Model (Wagner 2001): self-management support, delivery-system design, and management of clinical information. The program includes : - a case manager to coordinate and provide care and follow up; - clinical protocols and tools to support interprofessional and systematic follow up; - training for clinicians; - patient's personalized cardiovascular health booklet; - tools to promote group sessions for patient education on cholesterol, hypertension, and diabetes. The general OBJECTIVE of this trial is to evaluate and compare two STRATEGIES for implementing the TRANSIT program in Family Medicine Groups (FMGs): 1. facilitation, and 2. passive diffusion. Passive diffusion is the usual strategy where clinicians implement an intervention program by themselves. Facilitation is a strategy whereby a facilitator provides support to a team of clinicians to help them introduce the changes required to implement the program into practice. The hypothesis is that facilitation will be more efficacious to implement the program than passive diffusion: - it will enhance the provision of cardiovascular preventive care; - it will enhance interprofessional collaboration; - it will enable more efficaciously the implementation of new clinical processes; - it will improve patient clinical outcomes; - it will cost more in the short term, but will have positive economic impact in the long term; - there will be less "undesired effects" of all types related to implementation. To test the hypothesis, we assess the efficacy of the implementation strategies to enhance interprofessional collaboration and better support patients in the management of their conditions. Impact on provision of care, interprofessional collaboration, clinical processes, and patient clinical outcomes (values, therapeutic targets, and lifestyle habits) will be evaluated. Moreover, the implementation cost related to each strategy will be estimated. We complement the trial with qualitative methods to document the perceptions of clinicians, facilitators, patients and members of the family regarding the TRANSIT program, the implementation strategies and the observed changes in the clinical practices and outcomes.