View clinical trials related to Diabetic Kidney Disease.
Filter by:Background: Diabetes is common among American Indian people and diabetic kidney disease is a common complication. Kidney disease caused by diabetes can lead to the need for kidney replacement, by dialysis or kidney transplant, and is also associated with higher risk of early death. A new diabetes medicine called empagliflozin may slow kidney disease from type 2 diabetes. Researchers want to learn if it protects the kidneys when used in very early stages of diabetic kidney disease. Objectives: To see if empaglifozin delays kidney disease development. Eligibility: Adults 18-64 years old who are at least half American Indian and have had type 2 diabetes at least 5 years Design: Participants will be screened with health questions, blood pressure, and blood and urine tests. Participants will have: - Medical history - Physical exam - Blood, urine, and stool samples taken - Scan of the kidneys and liver. Participants will lie on a table that slides into an MRI machine. They will hold their breath for up to 20 seconds and the MRI machine will take images of their kidneys and liver. They will then repeat this with a small device that vibrates on their side. - Kidney tests. A needle will be placed in a vein in each arm for 4 hours. Blood pressure will be taken. Participants will drink several quarts of water and urinate every 20 minutes. Urine and blood samples will be collected. Two liquids will be injected into their veins to measure kidney function. - Photos of the back of the eyes - Kidney biopsy. Participants will have a scan and get drugs to make them sleepy. Up to four very small pieces of kidney will be removed by needle. After the biopsy participants will be monitored for at least 4 hours. - Nerve tests Participants will take the study drug or placebo pill once a day. Participants will attend for tests every twelve weeks and have more extensive kidney function tests once a year. After 3 years, participants will have another kidney biopsy and then stop taking the study drug. They will have a final kidney function test 2 months later.
The purpose of this study is to investigate the therapeutic effect and safety of Jinshuibao Capsule on diabetic kidney disease in T2DM patients.
To explore the efficacy of Ivabradine for the treatment of microalbuminuria in patients with type 2 diabetes and coronary heart disease.
This study will be a prospective, clinical pilot study in CKD patients to show whether Empagliflozin in addition to ACEi treatment significantly increases Ang 1-7 levels compared to ACEi treatment alone. Null and alternative hypotheses: H0: Empagliflozin in addition to ACEi treatment does not increase Ang 1-7 levels more than ACEi treatment alone. H1: Empagliflozin in addition to ACEi treatment significantly increases Ang 1-7 levels compared to ACEi treatment alone Methodology: Two groups of 24 chronic kidney disease (CKD) patients, respectively, with and without type 2 diabetes will be randomized into the study medication or placebo group. The number of patients per treatment arms is n = 12. Included and consented patients will be subjected to an initial 2-week run-in period for conversion of current RAS blocking medications to ACEi therapy with enalapril or ramipril and respective dose titration to 10 mg enalapril 2 x daily and 10 mg ramipril 1 x daily. Additional antihypertensive medication will be standardized as feasible, with the primary goal of keeping blood pressure as recommended by KDIGO. Following the 2-week run-in phase, all study patients will be subjected to blood collection including the first RAS quantification (RAS Fingerprint) and assessment of HDL composition, as well as urinary analysis and bioimpedance fluid status assessment (BCM measurement). Subsequently, patients will be randomized to either receive empagliflozin (at a dose of 10 mg daily) or placebo. Subsequently, biweekly study visits including electrolyte and glucose (plasma and urine) monitoring as well as BCM measurement will take place. After 12 weeks of study medication intake, a concluding study visit will be scheduled for final RAS quantification (RAS Fingerprint) and HDL analyses as well as final blood and urinary analysis and BCM measurement. Initially, blood and urine will be collected at the clinical visit as part of the routine blood obtainment (no additional effort on patients). From these routine measurements we will be able to extract information regarding the patient's current CKD stage as well as other relevant laboratory parameters (e.g. HbA1c, UACR, etc.). Furthermore, we will document the patient's current medication and significant comorbidities. Primary analysis variable/endpoint: The difference of Ang 1-7 increase from baseline between a 3-month treatment with empagliflozin on top of ACEi treatment compared to ACEi treatment alone Most important secondary analysis variables/endpoints: 1. Simultaneous quantitative changes of multiple RAS effector angiotensin levels determined by mass-spectrometry 2. Recurrence of Ang II levels determined by mass-spectrometry 3. HDL parameters (protein composition of HDL) 4. Renal parameters (albuminuria reduction measured by urinary albumin-creatinine ratio (UACR), renal function (estimated glomerular filtration rate (GFR), serum-creatinine) 5. Urinary electrolyte levels 6. Urinary glucose levels 7. Urinary RAS metabolites (angiotensinogen, ACE and ACE2 levels, ACE2 activity) 8. Blood pressure determined by ambulatory blood pressure measurements 9. Body volume determined by bioimpedance fluid status assessment (BCM measurement) 10. OCR and ECAR in PBMCs determined by Seahorse Flux Analyzer 11. Assessment of reduction of salt sensitivity by using salt sensitivity test with empagliflozin
1. Name of Investigational Products Huangkui capsule. 2. Trial Topic A Randomized, Double-blinded, Parallel, controlled, Multicenter Clinical Trial of Huangkui Capsule in Treating Type II Diabetic Nephropathy (DKD) 3. Trial Objectives Primary objective:To evaluate HuangKui capsule efficacy for treatment of type II diabetes ACR. Secondary objective: To evaluate the efficacy of HuangKui capsule on 24-hour urinary protein changes、reduce PCR-increase eGFR, improve micro-inflammatory state, and improving Traditional Chinese medicine clinical efficacy 4. Trial Design Designed as a block randomized, double-blinded, parallel controlled, multi-center clinical trial.
This study is a randomized, double-blinded, placebo-controlled clinical trial on type 2 diabetic Kidney Disease in early stage ( microalbuminuria excretion rate = 20-200mg/min) to evaluate the therapeutic effect of tang shen prescription. 632 participants will be recruited for the study, all of whom had type 2 diabetes, serum creatinine concentrations is normal, and no evidence of non-diabetic renal diseases. The subjects will be randomized to treatment with either tang shen prescription or placebo.
The study will investigate, primarily, the safety, feasibility and tolerability and, secondarily, the preliminary efficacy of an allogeneic bone marrow-derived Mesenchymal Stromal Cell (MSC) therapy (ORBCEL-M) in study subjects with type 2 diabetes (T2D) and progressive diabetic kidney disease (DKD).
The purpose of the study is to determine the effect of Liraglutide on albuminuria in type 2 diabetes.
The purpose of this study was to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.
The primary objective of this study is to evaluate the pharmacokinetics (PK) of selonsertib in participants with impaired hepatic function relative to matched, healthy controls.