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Diabetic Nephropathies clinical trials

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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: NCT04224428 Completed - Clinical trials for Diabetic Kidney Disease

Role of Fexofenadine in Diabetic Kidney Disease

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

- This study will that will be conducted on 60 outpatients previously diagnosed with type 2 diabetes mellitus. - Patients will be recruited from Internal Medicine Department, Tanta University Hospital, Tanta, Egypt. This study will be randomized, controlled, parallel, prospective clinical study. Accepted patients will be randomized into 2 groups as the following - Group 1 (Control group): 30 patients will receive maximum tolerated dose of ACEI for six months - Group 2 (Fexofenadine group): 30 patients will receive maximum tolerated dose of ACEI plus fexofenadine tablets 60 mg once daily for six months The primary end point will be the change in Urinary albumin to creatinine ratio (UACR) after six months of treatment

NCT ID: NCT04176276 Completed - Type2 Diabetes Clinical Trials

Determining Serum and Urinary Levels of miRNA 192 and miRNA 25 in Patients With and Without Type 2 Diabetes.

Start date: March 1, 2018
Phase:
Study type: Observational

Diabetes kidney disease (DKD) is the leading cause of end stage renal disease (ESRD) in western countries and its incidence is worryingly increasing worldwide. Cardiovascular disease shows a continuous relationship with declining of renal function in type 2 diabetes patients. Moreover, there is a strong evidence of all-cause mortality risk excess even in patients with early stages kidney disease. MicroRNA (miRNA) are small non-coding RNA molecules, containing 21-25 nucleotides, that modulate post-transcriptional gene expressions. In the past years many human miRNAs involved in the pathogenesis of renal disease have been discovered, such as miR-192, miR-194, miR-204 and miR-25. Among these, miR-192 and miR-25, are receiving greater attention while it seems that they play a role in glomerulosclerosis and renal fibrosis. However too few data are available in large publish trials among patients with renal impairment and the role of serum and urinary levels of miR-192 and miR-25 in people with preserved renal function remain unclear. To evaluate the association between serum and urinary expression of miR-192 and miR-25 and renal function (according to different extent of renal impairment) in patients with or without type 2 diabetes.

NCT ID: NCT04170543 Completed - Clinical trials for Diabetic Kidney Disease

A Phase 2b Diabetic Kidney Disease Study

Start date: November 18, 2019
Phase: Phase 2
Study type: Interventional

A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects with Diabetic Kidney Disease

NCT ID: NCT04074668 Completed - Diabetes Clinical Trials

Control of Renal Oxygen Consumption, Mitochondrial Dysfunction, and Insulin Resistance

CROCODILE
Start date: January 1, 2020
Phase:
Study type: Observational

Type 1 diabetes (T1D) is a complex metabolic disorder with many pathophysiological disturbances including insulin resistance (IR) and mitochondrial dysfunction which are causally related to the development of diabetic kidney disease (DKD) and which contribute to reduced life expectancy. Renal hypoxia, stemming from a potential metabolic mismatch between increased renal energy expenditure and impaired substrate utilization, is increasingly proposed as a unifying early pathway in the development of DKD. By examining the interplay between factors responsible for increased renal adenosine triphosphate (ATP) consumption and decreased ATP generation in young adults with and without T1D, this study hopes to identify novel therapeutic targets to impede the development of DKD in future trials. The investigators propose to address the specific aims in a cross-sectional study with 30 adults with T1D and 20 controls without a diagnosis of diabetes. For this protocol, participants will complete a one day study visit at Children's Hospital Colorado. Patients will undergo a Dual-energy X-Ray Absorptiometry (DXA) scan to assess body composition, renal Magnetic Resonance Imaging (MRI) to quantify renal oxygenation and perfusion, and a Positron Emission Tomography/Computed Tomography (PET/CT) scan to quantify renal O2 consumption. After the PET and MRI, participants will undergo a hyperinsulinemic-euglycemic clamp to quantify insulin sensitivity. Glomerular Filtration Rate (GFR) and Effective Renal Plasma Flow (ERPF) will be measured by iohexol and PAH clearances during the hyperinsulinemic-euglycemic clamp. To further investigate the mechanisms of renal damage in T1D, two optional procedures are included in the study: 1) kidney biopsy procedure and 2) induction of induced pluripotent stem cells (iPSCs) to assess morphometrics and genetic expression of renal tissue.

NCT ID: NCT04027530 Completed - Clinical trials for Type 2 Diabetes Mellitus

Renal Oxygenation, Oxygen Consumption and Hemodynamic Kinetics in Type 2 DIabetes: an Ertugliflozin Study.

ROCKIES
Start date: December 10, 2020
Phase: Phase 4
Study type: Interventional

Current study will render insight in to the role of renal hypoxia in the diabetic kidney and is able to associate its finding with measurements of renal perfusion and glomerular filtration rate. Moreover, this research will focus on the effects of sodium-glucose cotransporter 2 inhibition on renal tissue oxygenation and oxygen consumption as well as a change in intrarenal hemodynamics and perfusion, and a shift of fuel metabolites. Elucidation the mechanisms underlying the effects of SGLT2 inhibition will advance our knowledge and contribute to their optimal clinical utilization in the treatment of chronic kidney disease in diabetes and possibly beyond.

NCT ID: NCT04026165 Completed - Clinical trials for Diabetic Kidney Disease

Study to Evaluate the Efficacy and Safety of Selonsertib in Participants With Moderate to Advanced Diabetic Kidney Disease

MOSAIC
Start date: July 24, 2019
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate whether selonsertib (SEL) can slow the decline in kidney function in participants with moderate to advanced diabetic kidney disease (DKD).

NCT ID: NCT03909269 Completed - Type2 Diabetes Clinical Trials

Glycaemic Markers in Persons With Type 2 Diabetes on Haemodialysis

GLYCOHEMO
Start date: April 1, 2018
Phase:
Study type: Observational

To investigate the correlation between the mean glucose concentration measured by continuous glucose monitoring (CGM) and the estimated mean blood glucose from glycated haemoglobin A1c (HbA1c) in persons with type 2 diabetes and on chronic haemodialysis. Furthermore, the aim is to compare CGM and HbA1c with glycated albumin and fructosamine.

NCT ID: NCT03889236 Completed - Diabetes Mellitus Clinical Trials

Dietary Interventions on Glycocalyx Dimensions in South Asian Patients With Diabetic Nephropathy.

Glycotreat
Start date: May 3, 2018
Phase: N/A
Study type: Interventional

Evaluate the effect of a fasting mimicking diet and a food supplement on the microvascular health and urinary heparanase levels in South Asian type 2 diabetic patients with albuminuria.

NCT ID: NCT03885362 Completed - Clinical trials for Chronic Kidney Diseases

Assessment of the Accuracy of Continuous Glucose Sensors in People With Diabetes Undergoing Haemodialysis

ALPHA
Start date: December 11, 2019
Phase: N/A
Study type: Interventional

The purpose of the study is to assess the accuracy of the Dexcom G6 CGM system and the Abbott FreeStyle Libre flash system compared to the reference standard YSI (Yellow Spring Instruments) glucose in people with diabetes undergoing haemodialysis. The Dexcom G6 is a continuous glucose monitoring system that gives blood glucose values in real-time and includes alarms if the glucose is very low or high. The Abbott FreeStyle ibre flash system is an intermittent glucose monitor that shows the blood glucose values when it is waved near the sensor and does not include alarms. The YSI glucose analysis will take place as a normal part of haemodialysis, by testing blood glucose levels during the haemodialysis session. The study will last 28 days per participant