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Diabetic Nephropathy clinical trials

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NCT ID: NCT02237352 Active, not recruiting - Diabetes Mellitus Clinical Trials

Mechanisms of Diabetic Nephropathy in Ecuador

Start date: September 15, 2014
Phase:
Study type: Observational [Patient Registry]

The prevalence of diabetes mellitus (DM) is increasing worldwide, suggesting that 45% of diabetics are undiagnosed. DM induces a kidney disease called diabetic nephropathy (DN) which is the largest single cause of end-stage renal disease and dialysis requirement. In South America the prevalence of DM and chronic kidney disease has increased, and great disparity exists among countries in regards to access to the dialysis treatment. It has been considerate that Hispanic origin increases the risk for DM. The South Americans have distinctive habits, culture, environment, behavior and genetic background and the factors involved in DN have not been defined yet. The early kidney lesions such as neoangiogenesis (pathologic generation of the new blood vessels) and extracellular matrix expansion have been described. The vascular endothelial growth factor A (VEGF) has been linked to angiogenesis, but the role of VEGF in DN has not been elucidated yet. VEGF signals mainly through VEGF receptor 2 (VEGFR2). VEGFR2 interacts with alphaV beta3 integrin (AVB3) in kidney. Additionally tenascin C is expressed in the extracellular matrix. Tenascin C and the tenascin C/AVB3 complex have also been linked to angiogenesis, however their roles have not been unveiled yet in the DN. Investigators hypothesize that VEGF signaling and tenascin C play an important role in DN and that VEGFR2, AVB3 and tenascin C interact. The purposes of this study is to characterize social, environmental and biological factors implicated in the DN in Ecuador and define the role of VEGF signaling and tenascin C in the pathogenesis of the DN. Investigators propose to study factors involved in DN in diabetic and non-diabetic adults from general population, with and without DN. In a single time investigators will evaluate demographics data, habits, personal and family history through a survey. Investigators will measure anthropometrics parameters and blood pressure; investigators will quantify blood glucose, glycosylated hemoglobin A1c and proteinuria. In addition investigators will examine the role of tenascin C and VEGF signaling by analyzing paraffin embedded kidney tissue, plasma and urine samples. Characterizing the factors involved in the DN from Hispanic people is key to establish adequate strategies of prevention, diagnosis and treatment in this population. Furthermore elucidating the role of proteins involved in DN may offer valuable tools for the development of new treatments.

NCT ID: NCT02205372 Completed - Clinical trials for Diabetic Nephropathy

Safety, Tolerability and Pharmacokinetic Study of MT-3995 at a Low Dose in Subjects With Diabetic Nephropathy

Start date: July 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995 in Subjects with Diabetic Nephropathy.

NCT ID: NCT02204280 Completed - Clinical trials for Diabetic Nephropathy

The Significance of Urine UbA52 In the Diagnosis of Diabetic Nephropathy

Start date: August 2014
Phase: N/A
Study type: Observational

Definite diagnosis of diabetic nephropathy is currently based on renal biopsy findings. In most cases, however, the diagnosis can be reliably made in patients with macroalbuminuria in the presence of diabetic retinopathy.Microalbuminuria is often used as a prognostic marker in type 1 diabetes, because approximately 50% of type 1 diabetes patients with microalbuminuria will eventually develop diabetic nephropathy. Conversely, microalbu- minuria is of much less value as a marker in DM because it has a variety of causes, including hypertension. Thus, additional markers are needed to identify patient groups with a high risk of developing overt diabetic nephropathy. The aims of this study is checking urine UbA52 levels with ELISA to identify its significance in the diagnosis of diabetic nephropathy.

NCT ID: NCT02194790 Completed - Clinical trials for Chronic Kidney Disease

Effect of Integrated CKD Care Program in Early Diabetic Nephropathy in Primary Health Care Setting.

Start date: December 2012
Phase: N/A
Study type: Interventional

Chronic kidney disease (CKD) is a major health problem in Thailand. Previous studies have demonstrated that integrated pre-dialysis care may slow the decline in renal function (Nephrol Dial Transplant.2009 Nov;24(11):3426-33). It is interesting to know whether early intervention especially in high risk groups like Diabetic may also improve outcome of these patients in primary health care setting resulting in delay of CKD progression.

NCT ID: NCT02156843 Terminated - Clinical trials for Diabetic Nephropathy

Pyridorin in Diabetic Nephropathy

PIONEER
Start date: June 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of oral Pyridorin 300 mg BID in reducing the rate of progression of nephropathy due to type 2 diabetes mellitus.

NCT ID: NCT02150707 Completed - Type 2 Diabetes Clinical Trials

The Differential Effects of Diabetes Therapy on Inflammation

Start date: May 2014
Phase: N/A
Study type: Observational

This study aims to determine if different diabetes treatments have different effects on inflammation; in particular, kidney inflammation. This type of inflammation is common in people with diabetes, and can lead to kidney failure. This study will investigate the effect of different types of diabetes treatment on kidney inflammation. This will help us to decide if certain types of medicine should be preferred in people with evidence of inflammation in their kidneys, as this may help prevent major complications including kidney failure.

NCT ID: NCT02065791 Completed - Clinical trials for Diabetes Mellitus, Type 2

Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy

CREDENCE
Start date: February 17, 2014
Phase: Phase 3
Study type: Interventional

The goal of this study is to assess whether canagliflozin has a renal and vascular protective effect in reducing the progression of renal impairment relative to placebo in participants with type 2 diabetes mellitus (T2DM), Stage 2 or 3 chronic kidney disease (CKD) and macroalbuminuria, who are receiving standard of care including a maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB).

NCT ID: NCT02040441 Completed - Clinical trials for Diabetic Retinopathy

Proteomic Prediction and Renin Angiotensin Aldosterone System Inhibition Prevention Of Early Diabetic nephRopathy In TYpe 2 Diabetic Patients With Normoalbuminuria

PRIORITY
Start date: March 2014
Phase: Phase 2/Phase 3
Study type: Interventional

This is a prospective, multicenter, randomized, double blind, placebo-controlled and a prospective observational study. This study will be conducted at 15 study centers in various European countries. 1777 participant between 18 to 75 years old with Type 2 diabetes mellitus and normoalbuminuria participate in the study. The study period is 2 - 4.5 years (excluding the 6 week screening period). Depending on the risk score of the urinary protein pattern, participants have been stratified into an observational group or an interventional group. Participants with the low risk pattern (observational group) attend visits annually after screening and baseline. Participants with the high risk pattern (interventional group) attend study visits every 13 weeks after screening and baseline. The interventional group has been allocated into one treatment group either receiving spironolactone or placebo. A placebo is a medicine without a pharmaceutical substance. The allocation to one of the two treatment groups has been done by a random distribution procedure established before the study start. The results of the urine sample from the Screening visit has been analysed and the urine proteomic pattern is determined to be either low- or high risk pattern and will determine the further study program. Participants with a low-risk pattern (observational group): During the study period, participants attend an annual project visit, were regular diabetes care is performed and three urine samples are analysed for albuminuria. Participants with a high-risk pattern (intervention group): Participants with a high-risk pattern have been randomized to either spironolactone treatment or placebo. The treatment is one tablet for oral use to be taken once a day for the entire study period. Four times each year (every 13th week) a study visit is conducted including examination of three urine samples for albuminuria. This study aims to: 1. Confirm in a prospective multicenter study of normoalbuminuric type 2 DM patients that the urinary proteome test identifies patients with a high risk for development of microalbuminuria. 2. Demonstrate the clinical utility of the test by showing that aldosterone blockade in high-risk patients can reduce progression to microalbuminuria in comparison to placebo, on the top of standard treatment in a randomized double-blind, placebo-controlled multicenter study.

NCT ID: NCT02035891 Active, not recruiting - Clinical trials for Diabetic Nephropathy

Low-dose Colchicine in Patients With Type 2 Diabetes Mellitus and Microalbuminuria

Start date: December 2013
Phase: N/A
Study type: Interventional

1. The primary objective of this study was: in patients with type 2 diabetes and microalbuminuria who have been receiving stable treatment of angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker (ACEI/ARB) for at least 3 months, whether low-dose colchicine slows the progression of microvascular complications. 2. The secondary objective of this study was: (1) whether low-dose colchicine could reduce Urinary Albumin To Creatinine Ratio (UACR), or improve eGFR in patients with type 2 diabetes and microalbuminuria; (2) whether low-dose colchicine decreases carotid intima-media thickness(IMT) in patients with type 2 diabetes and microalbuminuria; (3) whether low-dose colchicine reduces the risk of cardiovascular events or mortality in patients with type 2 diabetes and microalbuminuria.

NCT ID: NCT01935167 Completed - Clinical trials for Diabetic Nephropathy

To Determine the Efficacy and Safety of DW1029M on Microalbuminuria in Patients With Diabetic Nephropathy

Start date: October 2013
Phase: Phase 2
Study type: Interventional

Phase 2 clinical study to evaluate of the efficacy and safety of DW1029M on microalbuminuria in Patients With Diabetic Nephropathy