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Diabetic Kidney Disease clinical trials

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NCT ID: NCT05631119 Completed - Healthy Clinical Trials

Biorepository of Biospecimen Samples in Matched Healthy Control Participants and Participants Diagnosed With Diabetic Kidney Disease, Chronic Kidney Disease, or Type 2 Diabetes

SAN-08961
Start date: December 15, 2022
Phase:
Study type: Observational [Patient Registry]

The Investigators will generate a repository of human biosamples across therapeutic areas that will be used to identify disease-associated biomarkers and potential targets with immune and multi-omics profiling. This sample collection and analysis from people living with type 2 diabetes, or chronic or diabetic kidney disease will lay the groundwork for an extensive network of biosample access and linked datasets that will provide an invaluable resource for translational research.

NCT ID: NCT05086549 Completed - Proteinuria Clinical Trials

An Observation Study to Evaluate the Renoprotective Effect of Fimasartan in Patients With DKD and Proteinuria

FINALE
Start date: September 29, 2021
Phase:
Study type: Observational

This study aims to observe changes in various indicators of renal function, such as proteinuria at different time points: short-term (Week 8), 6 months (Week 26), and a year (Week 52), in patients with DKD and hypertension, who are given antihypertensives containing fimasartan, in an actual clinical environment where a variety of patient characteristics are reflected.

NCT ID: NCT05071287 Completed - Weight Loss Clinical Trials

Metabolism of Low Carbohydrate and Ketogenic Diet

Start date: June 3, 2021
Phase: N/A
Study type: Interventional

This study will assess the preliminary efficacy of a lifestyle intervention including low-carb/ketogenic diet and exercise, enhanced by self-monitoring through health technologies on weight and diabetes outcomes (Glucose, HbA1c) and diabetic complications (cognitive function, and renal function) in a 6-month randomized clinical trial in 60 overweight/obese adults with or without T2D. Renal function will be assessed via both traditional and novel biomarkers, including novel metabolites and mitochondrial function.

NCT ID: NCT05025540 Completed - Clinical trials for Diabetic Kidney Disease

Automatic Segmentation Ultrasound-based Radiomics Technology in Diabetic Kidney Disease

Start date: June 1, 2021
Phase:
Study type: Observational

Diabetic kidney disease is a common complication of diabetes and the main cause of end-stage renal disease. In this study, the investigator plan to enroll nearly 500 participant with/without DKD and to develop an automatic segmentation ultrasound based radiomics technology to differentiating participant with a non-invasive and an available way.

NCT ID: NCT05021705 Completed - Clinical trials for Diabetic Kidney Disease

Non Diabetic Causes of Chronic Kidney Disease in Type 2 Diabetic Patients

Start date: January 2016
Phase:
Study type: Observational [Patient Registry]

Determination of the possible causes of chronic kidney disease (CKD) in patients with type 2 diabetes mellitus with an atypical presentations of renal disease for proper management and thus improving renal outcome.

NCT ID: NCT04931030 Completed - Obesity Clinical Trials

Low Carbohydrate Diet in Diabetic Kidney Disease

Start date: March 15, 2019
Phase: N/A
Study type: Interventional

The current population of type 2 diabetes mellitus (T2DM) worldwide is over 200 million and Malaysia contributes to 1.2% of that number. The prevalence of T2DM in Malaysia has approximately tripled over the last three decades from 6.3% in 1986 to 17.5% of the adult population in 2015.T2DM is a progressive disease associated with debilitating microvascular and macrovascular complications. The prevalence of chronic kidney disease (CKD) in Peninsular Malaysia was high at 9.1% of the adult population in 2011. T2DM is the leading cause of renal failure for patients commencing dialysis, increasing from 53% of new dialysis patients in 2004 to 61% in 2013. Therefore, diabetic kidney disease (DKD) is a debilitating complication which not only imposes significant health problems but also confers financial burden on affected patients. There has been increasing amount of understanding in the complexity of the relationship between T2DM and obesity. As the prevalence of both conditions continue to demonstrate a parallel rise, the influence of obesity on T2DM is further marked. Thus, this has led to greater emphasis on weight loss in the management of T2DM. More recent anti-diabetic medications including SGLT-2 inhibitors and GLP1 agonists demonstrated greater efficacy in improving glycaemic control and their ability to produce weight reduction. In addition, there has been more interest in the effects of these drugs on retardation of renal disease progression. The mechanism is unclear, either attributed by direct drug effects on renal glomerular-tubular structures, through the Renin-Angiotensin-Aldosterone-System (RAAS), or other pathways. Another pausible explanation is the significant weight loss, which has been shown to have a significant effect of attenuation of renal disease. Weight reduction programs have long been a complex and tedious treatment plan which has inconsistent, non-duplicable and unpredictable outcomes. Most programs emphasized on medical nutrition therapy and lifestyle changes. There has been many different dietary plans which share a common goal ie to reduce calori intake whilst increasing energy expenditure. Few have been successfully reproducible, limited by either patient adherence or modest outcome. Low carbohydrate diet is a diet plan which stresses on reducing carbohydrate intake to less than 20g daily. Numerous studies have shown that weight loss could be obtained by reduction of calori intake in either the form of carbohydrate or fat. CKD patients are recommended to consume low protein diet of less than 0.6-0.7g/kg/day with little emphasis on calori or carbohydrate intake. This study, thus, aims to evaluate the effects of low carbohydrate and moderate fat (LCBD) in addition to low protein diet on renal disease in patients with DKD.

NCT ID: NCT04881123 Completed - Clinical trials for Diabetic Kidney Disease

SER150 vs Placebo in Diabetic Kidney Disease

Start date: August 18, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This study is to assess the efficacy and safety of SER150 administered for 24 weeks as a 15 mg twice a day BID dose (except on Day 168 15 mg QD) in participants with type 2 diabetes (T2D) and albuminuria in treatment with either an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin receptor antagonist (ARB).

NCT ID: NCT04635670 Completed - Type 1 Diabetes Clinical Trials

Effects of Probiotics and Fibers on Albuminuria in Persons With Type 1 Diabetes

ProFOS
Start date: June 29, 2020
Phase: N/A
Study type: Interventional

The primary objective is to assess the impact of three months' treatment with pre-/probiotic mix on markers of nephropathy and other comorbidity related to diabetes. A double blinded, randomized, placebo-controlled crossover, single-centre study including 46 patients with type 1 diabetes and albuminuria. The treatment period is 2 x 12 weeks with 6 weeks washout. The primary outcome is to evaluate the effect of pre-/probiotic mix on albuminuria.

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