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Albuminuria clinical trials

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NCT ID: NCT04295889 Enrolling by invitation - Albuminuria Clinical Trials

Towards HOMe-based Albuminuria Screening: an Implementation Study Testing Two Approaches

THOMAS
Start date: November 14, 2019
Phase: N/A
Study type: Interventional

Chronic Kidney Disease (CKD) is a worldwide major public health problem that is associated with an increased incidence of kidney failure and cardiovascular events, that lead a high burden for affected patients and high costs for society. Symptoms of CKD occur late, when kidney function drops to below 30%. At that time preventive measures will have only limited efficacy. Protein excretion in urine has increasingly been recognized as early marker of CKD, and is often associated with high blood pressure, diabetes, and/or high cholesterol levels. These are all important risk factors for progression of kidney and cardiovascular disease. Population screening for urinary protein loss could detect a considerable number of subjects with yet unknown risk factors for progressive kidney and cardiovascular disease who can benefit of early intervention. However, there is no validated method for population screening yet. The aim is to to develop a home based population screening for elevated urinary protein loss. Two screening methods will be investigated, and yield and cost-effectiveness of these screening methods will be evaluated

NCT ID: NCT04272359 Recruiting - Diet, Healthy Clinical Trials

Substitution of Sulfonylureas With New Generation of Hypoglycemic Drugs for the Treatment of Type 2 Diabetes Mellitus

Sulfa-Zero
Start date: May 6, 2019
Phase:
Study type: Observational [Patient Registry]

This is a multicentric, prospective, parallel groups study. Patient recruitment will be carried out at the U.O. Departmental Endocrinology and Diabetology ASST FBF Sacco, Fatebenefratelli and Ophthalmic Hospital, and at the SSD of Endocrine Diseases and Diabetology ASST FBF Sacco, L. Sacco Hospital. At the screening visit, patients being treated with sulfonylureas / glinids will be shifted, depending on the subject's biochemical and phenotypic characteristics, based on current prescribing criteria and diabetes complications, to one of 4 different types of treatment: 1. GROUP 1: SGLT2 inhibitors +/- Metformin 2. GROUP 2: DPP4 inhibitors +/- Metformin 3. GROUP 3: GLP1-RA + Long-acting insulin +/- Metformin 4. GROUP 4: SGLT2 inhibitors + DPP4 inhibitors +/- Metformin At the screening visit the clinician will evaluate which new treatment to assign to the patient, based on the subject's biochemical and phenotypic characteristics, current prescribing criteria and existing complications (Algorithm for the treatment of diabetes mellitus, SID-AMD Care Standard 2018)

NCT ID: NCT04127084 Recruiting - Type 2 Diabetes Clinical Trials

Effects of SGLT2 Inhibition Treatment on Different Levels of Albuminuria in Patients With Type 2 Diabetes

Start date: October 15, 2019
Phase: Phase 4
Study type: Interventional

Diabetic kidney disease has become the leading cause for ESRD worldwide.Albuminuria is a major risk factor for progression of diabetic nephropathy. SGLT2 inhibitors are the first antiglycaemic drugs with direct renoprotection, which are thought to protect the kidneys by lowering albuminuria, stimulating urinary glucose excretion ,reducing systemic blood pressure, while simultaneously improving multiple other risk factors in a glucose-independent manner. However, the precise mechanisms behind the renal beneficial effect of SGLT2 inhibitors are not entirely elucidated, although ongoing outcome trials will confirm these findings. This study is to assess the impact of three months of treatment with SGLT2 Inhibitions on different levels of albuminuria in patients with type 2 diabetes and to evaluate the effects of SGLT2 inhibition treatment on markers for podocyte damage , renal fibrosis, inflammation,oxidative stress and renin-angiotensin- aldosterone system.

NCT ID: NCT04073927 Recruiting - Clinical trials for Diabetes Mellitus, Type 1

Effect of Butyrate on Inflammation and Albuminuria in Patients With Albuminuria, Type 1 Diabetes and Intestinal Inflammation

Start date: August 5, 2019
Phase: N/A
Study type: Interventional

The objective is to assess the impact of 12 weeks supplement of sodium-butyrate twice daily or placebo on intestinal inflammation and albuminuria. A randomized, placebo-controlled, double-blind, two-site trial including 48 patients with type 1 diabetes, albuminuria and intestinal inflammation. Participants will be randomized 1:1 to active treatment or placebo for a period of 12 weeks. The primary endpoint is change from baseline to week 12 in intestinal inflammation, measured by fecal calprotectin.

NCT ID: NCT04063930 Recruiting - Clinical trials for Type 2 Diabetes Mellitus With Kidney Complications

The Effect of Sodium Zirconium Cyclosilicate on Albuminuria in Patients With Type 2 Diabetes and Hyperkalemia

ZIRCUS
Start date: October 2019
Phase: Phase 4
Study type: Interventional

To investigate whether concomitant treatment with Lokelma can improve the efficacy of standard blockade of the renin-angiotensin system in patients with type 2 diabetes, diabetic nephropathy and hyperkalemia.

NCT ID: NCT04061200 Not yet recruiting - Clinical trials for Type 2 Diabetes With Renal Manifestations

Renal Effects of Treatment With Empagliflozin Alone or in Combination With Semaglutide in Patients With Type 2 Diabetes and Albuminuria

EmpaSema
Start date: November 1, 2019
Phase: Phase 4
Study type: Interventional

The objective of this study is to evaluate the effect of treatment with semaglutide 1.34 mg/ml in combination with empagliflozin 25 mg, compared to treatment with empagliflozin 25 mg in combination with placebo on albuminuria in participants with type 2 diabetes and albuminuria. In a randomised, placebo-controlled, double-blinded, parallel trial we will include 80 patients with type 2 diabetes and albuminuria. Patients will start in a run-in phase of 26 weeks with empagliflozin 25 mg alone. After that, the patients will be randomised 1:1 to an active treatment period with semaglutide of 26 weeks or placebo for 26 weeks. The primary endpoint is change from randomisation to week 52 in albuminuria, measured in three morning urine samples.

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: NCT03806452 Recruiting - Sickle Cell Disease Clinical Trials

SIKAMIC (SIklos on Kidney Function and AlbuMInuria Clinical Trial)

SIKAMIC
Start date: May 28, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this phase IIb, international, multicentre, double-blind, randomised, placebo-controlled study is to determine the effect of hydroxycarbamide on albuminuria after 6 months of treatment in SCD adult patients.

NCT ID: NCT03667300 Completed - Renal Insufficiency Clinical Trials

Effect of Evogliptin on Albuminuria in Patients With Type 2 Diabetes and Renal Insufficiency

DA1229
Start date: March 16, 2017
Phase: Phase 2
Study type: Interventional

In this multi-center, randomized, double-blind, active-controlled, phase II non-inferiority study, we aimed to test the non-inferiority of evogliptin vs linagliptin in terms of reduction of albuminuria at week 24 from baseline in patients with type 2 diabetes having renal insufficiency.

NCT ID: NCT03622957 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Association Between Phthalates Exposure and Renal Function Impairment in TYpe 2 Diabetes

PURITY-2
Start date: August 10, 2018
Phase:
Study type: Observational

The global incidence of diabetic nephropathy (DN) is increasing, with no appreciable reduction in the percent of patients progressing toward end stage renal disease (ESRD) and dialysis (Tuttle et al, 2014, Winocour et al, 2018). Therefore, identification of modifiable risk factors and early biomarkers of progressive decline in kidney function is an urgent clinical need. Phthalates are environmental and dietary contaminants with a various array of use that are identified in many consumer and industrial products; among them, di-(2-ethylhexyl) phthalate (DEHP) and its metabolites (mono 2-ethylhexyl phthalate (MEHP), 5OH-MEHP (MEHHP) and 5oxo-MEHP (MEOHP)) are widely used (Kato et al 2004, Braun et al, 2013). They partially distribute to the human tissues and their urinary and serum levels are directly related; therefore, urinary concentration of phthalates is commonly used as proxy of their exposure in humans (Kato et al 2004). While the association between phthalates exposure and development of T2D is currently being explored (Dong et al 2017, Dales et al, 2018), little is known about their role in DN. Recent observations show that DEHP and its metabolites are associated with a higher prevalence of low-grade albuminuria and in children exposed to higher phthalates concentrations (Trasande et al, 2014, Wu et al, 2018), however such association has yet to be verified in adults. The environmental ubiquity of the phthalates enhances the importance of investigating the potential relation between their exposure and different degrees of renal function. (Kato et al 2004, Kataria et al, 2015). Given this premise, the investigators will explore this potential association in a population of subjects with T2D consecutively referring to the outpatient diabetes clinic in Santa Chiara Hospital, Pisa, enrolled on a volunteer basis. During their routine visit at Santa Chiara Hospital outpatient diabetes clinic participants will provide the results of blood tests prescribed as per standard clinical practice along with a first morning, overnight fasting, urine sample collected in a phthalates-free container. The investigators will record the participants' clinical history, physical examination and anthropometric measurements, will measure their renal function, evaluated by eGFR (calculated with the CDK-EPI formula), albumin excretion, fasting glucose, HbA1c%, and the exposure to phthalates, assessed by total concentrations of MEHP, MEOHP, MEHHP and adjusted for urinary creatinine. In this way, the investigators aim to point out the relationship of urinary phthalates with higher degrees of albuminuria and/or lower eGFR after adjustment for all potential confounders, including therapies.