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Diabetic Nephropathies clinical trials

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NCT ID: NCT04549324 Completed - Sleep Apnea Clinical Trials

Sleep Apnea, Coronary Atherosclerosis and Heart Failure in Diabetes Patients With Nephropathy

SLEEP
Start date: October 1, 2020
Phase:
Study type: Observational

Background: Diabetes, and especially diabetic kidney disease is associated with the development of cardiovascular disease such as calcification in the coronary arteries and heart failure. Sleep apnea is frequent among patients with diabetes and diabetic kidney disease and sleep apnea itself is a solitary risk factor in the development of cardiovascular disease. Nonetheless, sleep apnea is underdiagnosed in diabetes patients because of a discrepancy between sleep apnea severity and actual oxygen deficiency symptoms which makes the diagnosis difficult. For that reason, many diabetics have undiagnosed sleep apnea together with cardiovascular disease. Early discovery of sleep apnea among high risk diabetic patients may therefore be considered crucial before cardiovascular complications develop. For this reason, sleep apnea screening of high-risk diabetics can possibly improve early diagnostics of cardiovascular disease. Aim: This study will seek to establish the association between obstructive sleep apnea (OSA) and coronary calcification and heart failure in patients with diabetic kidney disease. The basic hypothesis of the study is that patients with diabetic kidney disease and concurrent OSA have a higher prevalence and severity of coronary calcification and heart failure compared to patients without OSA. Methods: Diabetic adult patients with scheduled check-ups at Steno Diabetes Center Aarhus, or Department of Renal Medicine on Aarhus University Hospital will be included in the study. Firstly, all included patients are screened for sleep apnea with the devices SomnoTouch® and ApneaLink®. Based on the sleep apnea determination; 40 patients with moderate-severe sleep apnea are compared with 40 patients without sleep apnea. In both groups, the patients are examined for calcification in the coronary vessels using a CT-scan while the function of the heart is examined by ultrasound (echocardiography). The stiffness of aorta is measured and performed using radial artery tonometry (SphygmoCor®). Furthermore, range of blood- and urine samples will be performed The perspectives are that patients with diabetes should be regularly evaluated for sleep apnea and that patients with moderate/severe sleep apnea should undergo further examination for cardiovascular disease even though the patients don't display any symptoms of either cardiovascular disease or sleep apnea.

NCT ID: NCT04534439 Completed - Clinical trials for Diabetes Mellitus, Type 2

Safety, Tolerability and Renal Effects of APX-115 in Subjects With Type 2 Diabetes and Nephropathy

Start date: August 24, 2020
Phase: Phase 2
Study type: Interventional

This is a proof of concept (PoC) trial to evaluate the safety, tolerability and renal effect of APX-115 in subjects with Type 2 diabetes and nephropathy.

NCT ID: NCT04531163 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

Possible Ameliorating Effect of N- Acetylcysteine (NAC) on Type-II Diabetes Induced Nephropathy

(NAC)
Start date: October 1, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The study is focused on the possible improving effect of N-acetylcysteine on nephropathy of type-2 diabetic patients. Study design: Prospective clinical based study. The aim of this work is to study the effect of N-acetylcysteine (NAC) on proteinuria and on the serum level of lipoprotein a (LPa) in diabetes induced nephropathy in type-2 diabetic patients.

NCT ID: NCT04419467 Completed - Clinical trials for Diabetic Kidney Disease (DKD)

Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease

Start date: September 14, 2020
Phase: Phase 2
Study type: Interventional

This phase 2a, double-blind, randomized, placebo-controlled study will assess the efficacy, safety, tolerability, and pharmacokinetics (PK), of repeat doses of CSL346 in subjects with diabetic kidney disease (DKD) and albuminuria receiving standard of care treatment.

NCT ID: NCT04403945 Completed - Clinical trials for Microcirculation Detection in Diabetic Patients

The Predictive Value of Sidestream Dark Field Imaging in Diabetic Nephropathy

Start date: June 1, 2019
Phase:
Study type: Observational [Patient Registry]

Diabetic microangiopathy refers to the pathological changes of arterioles, capillaries and venules in diabetic patients. Due to the impacts including glycol-metabolism disorder, disturbance of lipid metabolism, cytokine, oxidative stress and hemodynamic changes, the structure and function of microvessels are damaged accordingly. Diabetic nephropathy (DN) is one of the most common and serious chronic microvascular complications of diabetes, and becomes a leading cause of end-stage renal failure(ESRF). Presently, urinary albumin/creatinine ratio (UACR) is a widely accepted and relatively reliable indicator for early diagnosis of DN, however, there are 2/3 DN patients with normal albuminuria have decreased glomerular filtration rate (glomerular filtration rate, GFR) and abnormal structure of the kidney, one the other hand, the presence of albuminuria is associated with other vascular dysfunction and kidney disease other than DN, therefore its accuracy is increasingly being challenged. Sidestream dark field(SDF) imagining technology, as an emerging way to visualize blood vessels, is evaluated in a semi-quantitative manner and provides an effective means to study structure and function of microcirculation. Different from biochemical markers like albuminuria, SDF provides a visual information about vessel structure, density, and quality of diffusion. At present the research of sublingual microcirculation by SDF technique is mainly applied to microcirculation monitoring in patients in the intensive care unit or laboratory animal models with acute hemorrhagic shock to assess the potential of being a tool of diagnosis and treatment prognostic indicator, no relevant research has been carried out to evaluate the predictive value of diabetic microangiopathy in literature so far. Herein, the investigators designed the study based on SDF imaging to collect scientific data, thus providing strong support for the early assessment and diagnosis of diabetic nephropathy and possibly guiding individual therapy in the future.

NCT ID: NCT04387448 Terminated - Diabetes Mellitus Clinical Trials

A Study of TRPC5 Channel Inhibitor in Patients With Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change Disease

Start date: July 28, 2020
Phase: Phase 2
Study type: Interventional

This is a phase 2a study evaluating the safety and tolerability of multiple ascending doses of GFB-887 in patients with diabetic nephropathy (DN), focal segmental glomerulosclerosis (FSGS), and treatment-resistant minimal change disease (TR-MCD).

NCT ID: NCT04380584 Completed - Clinical trials for Diabetic Nephropathies

Relation Between Plasma Apelin Level and Diabetic Nephropathy in Type 2 Diabetes Patients.

Start date: November 30, 2019
Phase:
Study type: Observational [Patient Registry]

Diabetic nephropathy (DN) is the commonest cause of chronic kidney disease, and proteinuria isn't determent factor for the end stage renal disease in diabetics. Apelin is adipokine and have a beneficial role in early prediction of diabetic nephropathy. Few studies were done about apelin in diabetes. Purpose of the study: to investigate the association between the apelinergic system and diabetic nephropathy.

NCT ID: NCT04317430 Completed - Clinical trials for Diabetic Nephropathies

Niclosamide Role in Diabetic Nephropathy

Start date: February 1, 2020
Phase: Phase 3
Study type: Interventional

This study is randomized, controlled, parallel, prospective clinical study will be conducted on 60 patients diagnosed with type 2 diabetes mellitus at least five years ago. Patients will be recruited from Tanta University Hospital, Tanta, Egypt. Accepted patients will be randomized into 2 groups as the following: Control group: 30 patients will receive maximum tolerated dose of ACEI plus placebo pills for six months Treatment group: 30 patients will receive maximum tolerated dose of ACEI plus niclosamide tablets 1 gram once daily for six months The primary end point will be the change in Urinary albumin to creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR) after six months of treatment

NCT ID: NCT04238702 Completed - Clinical trials for Diabetes Mellitus, Type 2

Renohemodynamic Effects of Combined empagliflOzin and LosARtan

RECOLAR
Start date: November 4, 2020
Phase: Phase 4
Study type: Interventional

Worldwide, diabetic kidney disease (DKD) is the most common cause of chronic and end stage kidney disease. In parallel with the ever-increasing rates of obesity and type 2 diabetes (T2D), the incidence of DKD is expected to further increase in the coming years. DKD is a multi-factorial condition, involving pathophysiological factors such as chronic hyperglycemia, obesity, systemic- and glomerular hypertension, dyslipidemia, oxidative stress and pro-inflammatory cytokines. Large-sized prospective randomized clinical trials indicate that intensified glucose and blood pressure control, the latter especially by using agents that interfere with the renin-angiotensin-aldosterone system (RAS), halts the onset and (particularly) the progression of DKD, in both type 1 diabetes mellitus (T1DM) and T2DM patients. However, despite the wide use of angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), a considerable amount of patients develop DKD, indicating an unmet need for renoprotective therapies. Sodium-glucose linked transporters (SGLT-2) inhibitors are a relatively novel glucose-lowering drug for the treatment of T2DM. These agents seem to exert pleiotropic actions 'beyond glucose control'. SGLT-2 inhibitors decrease proximal sodium reabsorption and decrease glomerular pressure and albuminuria in type 2 diabetes. In addition, SGLT-2 inhibitors reduce blood pressure and body weight. At this point in time, the renoprotective mechanisms involved with SGLT-2 inhibition still remain speculative, though a consistent finding is that SGLT-2 inhibitors reduce estimated eGFR after first dosing, which is reversible after treatment cessation. This "dip" indicates a renal hemodynamic phenomenon reminiscent of the RAS blockers and is thought to reflect a reduction in intraglomerular pressure. The potential renoprotective effects and mechanisms of combination therapy of SGLT-2 inhibitors and RAS inhibitors have not been sufficiently detailed in human type 2 diabetes. Therefore, the current study aims to explore the underlying mechanism of the improved renal hemodynamics and mechanistics of mono- and combination therapy with an SGLT-2 inhibitor and a RAS inhibitor on renal physiology in metformin and/or SU-treated T2DM patients.

NCT ID: NCT04235621 Terminated - Clinical trials for Diabetic Nephropathies

A Study to Understand the Genetics and Clinical Course of Focal Segmental Glomerulosclerosis (FSGS), Treatment-Resistant Minimal Change Disease (TR-MCD), and Diabetic Nephropathy (DN)

Start date: December 20, 2019
Phase:
Study type: Observational

This is a study with 2 parts. Part 1 comprises a visit to collect biological samples necessary for the molecular characterization of chronic kidney disease. Part 2 comprises an observational period of 5 visits over a period up to 8 weeks. During Part 2, baseline tests will be conducted, and urine will be collected approximately every 2 weeks for 8 weeks. Patients may participate in Part 1, Part 2, or both, and will be followed for up to 1 year consisting of data collection from the patient's medical records and home collection of urine samples every 4 months.