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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT02895113 Not yet recruiting - Diabetes Clinical Trials

Aspirin and Renal Disease Progression in Patients With Type 2 Diabetes

LEDA
Start date: January 2017
Phase: Phase 3
Study type: Interventional

The pathophysiology of diabetes is multifactorial. Beyond genetic susceptibility loci, a lot of acquired risk factors are involved in the development and progression of the disease. Chronic complications of diabetes can be divided into vascular and nonvascular. The risk of developing complications increases with the duration of hyperglycemia, and usually become apparent in the second decade of hyperglycemia. Vascular complications are further subdivided into microvascular (retinopathy, nephropathy and neuropathy) and macrovascular (coronary artery disease, peripheral arterial disease, cerebrovascular disease). It is estimated that the annual decline of estimated glomerular filtration rate (eGFR) in diabetic adults is about 2.1-2.7 ml/min. While there is consolidated evidence about the use of aspirin (ASA) for secondary prevention in diabetic patients, there is no consensus on the use in primary prevention; the use of ASA in these patients is at physician discretion. ASA is an effective antithrombotic agent that inhibits the production of thromboxane (Tx) A2 and other prostaglandins by blocking cyclooxygenase (COX). In patients treated with aspirin, serum TxB₂ level is the most reliable in vivo indicator of COX-1 inhibition than TxA2, due to its short half-life and artifacts associated with platelet activation ex vivo. COX are present in the kidney in the macula densa, in the medulla and in the interstitium. Experimental animals models have demonstrated that COX are involved in regulation of renal blood flow. In particular, in a murine animal model, after the administration of COX inhibitors such as aspirin and celecoxib, it was observed an improvement in renal plasma flow and eGFR, suggesting a role for Tx in the progression of renal damage However, data on the relationship between aspirin and renal function in humans are scarce. In a recent work lead on a large cohort of 800 patients with non-valvular atrial fibrillation, ASA use was associated with a reduced progression of eGFR <45 ml/min during 2 years of follow-up. Furthermore, basal levels of urinary excretion of TxB2, correlated inversely with the use of aspirin and with the decrease of eGFR at follow-up. The aim of the study is to evaluate the decline in renal function in diabetic patients treated with low-dose aspirin (100 mg/day) vs. untreated diabetic patients.

NCT ID: NCT02882477 Not yet recruiting - Diabetes Mellitus Clinical Trials

Treatment of Wolfram Syndrome Type 2 With the Chelator Deferiprone and Incretin Based Therapy

Start date: December 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Patients who are genetically diagnosed with the recently reported and rare Wolfram syndrome type 2 ( WFS2) and have the degenerative and symptomatic disease including signs such as diabetes, platelet aggregation defect or visual problems will be asked to participate in this study. Knowing the pathomechanism of WFS2 with rapid cell death, after doing baseline investigations to asses the severity of their disease, the participants will be offered a chelator therapy with in addition to the antioxidant Acetylcystein, in diabetic patients an Incertin (GLP-1 ) therapy will be offered as well. The baseline investigations will be repeated after 2 months and after 5 months of therapy in order to asses the progression of the disease and to show if the chelator and anti oxidant therapy and in diabetic patients the GLP-1 therapy could stop the progression of the disease.

NCT ID: NCT02854748 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type II

Evaluate the Drug-drugs Interaction Between Lobeglitazone and Empagliflozin

Start date: August 2016
Phase: Phase 1
Study type: Interventional

This study is a randomized, open-label, multiple dosing, crossover study to evaluate the drug-drugs interaction between Lobeglitazone and Empagliflozin in healthy male volunteers

NCT ID: NCT02843724 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Integrative Care for Type 2 Diabetes

Start date: July 2016
Phase: Phase 1/Phase 2
Study type: Interventional

A two year, two arm pragmatic trial to investigate the integration of naturopathic care with conventional medical care to provide additional benefit beyond that of conventional medical care alone in achieving adequate control of diabetes.

NCT ID: NCT02826759 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Serum Sphingolipidomic Analyses in Healthy, Diabetic and Prediabetic Subjects

Start date: July 2016
Phase: N/A
Study type: Observational

This study is designed to compare the serum sphingolipidomic analyses in healthy, pre-diabetic and diabetic subjects. age, sex and BMI are matched among these three groups. As ceramide, sphingosine, sphingosine-1-phosphate and sphinganine are involved in inflammation, immunity and cancer, investigators proposed a hypothesis that sphingosine-1-phosphate and other sphingolipids may be associated with the progress of type 2 diabetes. sphingolipids may be a biomarker for diabetes.

NCT ID: NCT02738996 Not yet recruiting - Diabetes Clinical Trials

Role of Interrupting Sedentary Time in Management of Type-2 Diabetes

Just_StandUp
Start date: May 2016
Phase: N/A
Study type: Interventional

Type-2 diabetes, a common non-infectious disease, is the result of impaired insulin function and insulin production in the body. In type-2 diabetic patients, postprandial glucose control, lipid control and reduction of insulin resistance are crucial to deter the development of diabetes related complications (e.g. retinopathy, nephropathy, neuropathy and cardiovascular diseases), pancreatic β cells failure, morbidity and mortality. Currently, diet, exercise and standard oral medicines are used to treat type-2 diabetes. However, providing the most effective treatment to control postprandial glucose and lipid; and to preserve the pancreatic β cells is challenging because poor metabolic profiles are still detected in type-2 diabetic patients. Therefore, understanding the factors influencing the poor metabolic profiles and adjunct therapy to manage type-2 diabetes are really important to tackle this disease. In modern society, people are spending most of their waking time in sedentary behaviour, which is primarily prolonged sitting. Prolonged sedentary time is associated with increased postprandial glucose, lipid and insulin resistance. In contrast, frequent interruption of prolonged sitting with short light activity break reduces postprandial glucose, triglyceride cholesterol and insulin resistance. However, how frequently patients should interrupt sitting, potential longer-term effect of short activity break on reduction of postprandial glucose, triglyceride cholesterol and insulin resistance, and the knowledge, beliefs and experiences on the use of technology to decrease sedentary behaviour and improve glycaemic control are not investigated in type-2 diabetic patients. Therefore, it would be relevant to investigate this to prove the therapeutic role of frequent short activity break in sedentary time in the management of type-2 diabetes. Primary Research Objective: 1. To investigate the dose-response effect of frequency/number of light intensity walking breaks of sitting on postprandial glucose, insulin, C-peptide and triglyceride cholesterol level. 2. To investigate the potential longer-term effect of light intensity walking breaks of sitting on glucose control using 24-h glucose data. Secondary Research Objectives: The secondary objectives are 1. To obtain data to inform the development of a future feasibility trial investigating the feasibility, compliance, adherence and longer-term effect of different frequencies of light intensity walking breaks in sitting time on glycaemic excursions in free-living. 2. To explore the knowledge, beliefs and experiences of those with Type 2 diabetes on the use of technology to decrease sedentary behaviour and improve glycaemic control, that could be used in the feasibility trial

NCT ID: NCT02719756 Not yet recruiting - Diabetes Mellitus Clinical Trials

Effect of SGLT-2 Inhibitor Dapagliflozin on Glycemic Variability in Patients With Diabetes Mellitus Type 2

Start date: April 2016
Phase: Phase 4
Study type: Interventional

This study will test the hypothesis that early use of combination therapy with dapagliflozin and metformin will provide good glycemic control with low glycemic variability and without hypoglycemic episodes, and will be better tolerated than up-titration of metformin monotherapy. The study will also correlate these benefits with glycated hemoglobin.

NCT ID: NCT02709031 Not yet recruiting - Diabetes Clinical Trials

Cicletanine in Hypertension With Diabetes: Added Magnesium Preserves Potassium and Sodium

CHAMP
Start date: June 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Cicletanine, which has been approved and launched for hypertension in France and Germany, has promise beyond hypertension in critically-unmet needs such as diabetes. It is evident from in vitro, animal and human studies that cicletanine's optimal dose in diabetes and other challenging, critically-unmet needs is likely to be higher than that for hypertension. Cicletanine's maximum tolerated dosage is not known, but the drug's dose-limiting effects are documented to be potassium loss and sodium loss from thiazide-type activity (one of the therapeutic mechanisms the drug is known to have); such thiazide-type losses are known to be reversed safely by magnesium. This trial explores the ability of magnesium to enhance cicletanine safety at higher doses in a trial involving patients with hypertension complicated by diabetes.

NCT ID: NCT02698618 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

PRotective Effect on the Coronary Microcirculation of Patients With DIabetes by Clopidogrel or Ticagrelor

PREDICT
Start date: March 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether Ticagrelor has a protective effect on microcirculation during percutaneous coronary interventions in patients with Diabetes mellitus type II or in a pre-diabetic status.

NCT ID: NCT02695706 Not yet recruiting - Diabetes Clinical Trials

Clinical Study, Opened, of Cutaneous Acceptability of a Topic Product in Normal Conditions of Use

Start date: April 2016
Phase: Phase 0
Study type: Interventional

The measured product in this research is a product for topical use, Laboratoires Mercurochrome Reparador e Protetor. The expected benefit to the use of the product is the improvement in skin hydration as measured by self perception of participant research and clinical evaluation and improvement in local microcirculation, assessed by instrumental measurements in feet of the study participants.