Mechanisms of Diabetic Kidney Disease in American Indians
- An ongoing study is looking at American Indians who have kidney problems caused by type 2 diabetes. Kidney disease due to type 2 diabetes is a major problem in American Indians. We previously found that early treatment of kidney disease with losartan was probably beneficial for reducing progression of the disease. Researchers now want to see if these benefits continue to be seen several years after the end of the treatment study.
- To study long-term benefit of losartan treatment for diabetic kidney disease in American Indians with type 2 diabetes.
- Participants in the American Indian diabetic kidney disease study (OH95-DK-N037).
- Participants will have a physical exam and medical history before starting the study. Blood and urine samples will be collected.
- Participants will have a set of tests as part of this study. Those who have severe kidney problems, such as kidney failure, will only have a basic kidney exam with scans. The remaining participants will have a full urine collection and analysis. They will also provide a kidney biopsy.
- Treatment will not be provided as part of this study.
Diabetic Kidney Disease
Diabetes Mellitus, Type 2
|Study Design:||Time Perspective: Prospective|
|Official Title:||Determinants of Diabetic Nephropathy in American Indians|
- End-Stage Renal Disease [ Time Frame: On-going ] [ Designated as safety issue: No ]
- Diabetic Neuropathy [ Time Frame: On-going ] [ Designated as safety issue: No ]
- Diabetic Retinopathy [ Time Frame: On-going ] [ Designated as safety issue: No ]
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||January 2035|
|Estimated Primary Completion Date:||December 2022 (Final data collection date for primary outcome measure)|
The purpose of this protocol is to examine the long-term impact of treatment with the angiotensin receptor blocker losartan on progression of diabetic kidney disease in American Indians with type 2 diabetes. All participants were enrolled previously in a 6-year randomized clinical trial under Protocol OH95-DK-N037. Once randomized treatment was completed, the subjects continued to be followed under that protocol with annual renal clearance studies. Of the 170 participants originally enrolled in the trial, about 110 remain and they are eligible to enroll in this observational study. The present protocol replaces the clinical trial protocol and expands the scope of observational studies to be conducted in these well-characterized patients.
Participants will continue to undergo annual renal clearance studies to measure glomerular filtration rate and renal plasma flow, unless they have developed kidney failure. At the initial visit, we will also conduct tests of the peripheral and autonomic nervous system to determine the frequency and severity of diabetic neuropathy in this cohort and identify linkages between diabetic kidney disease and diabetic neuropathy. We will also perform a kidney biopsy at the initial visit to examine the extent of structural changes that have occurred since the last kidney biopsy done at the end of the clinical trial. Tissue from this biopsy will also be used for further gene expression and epigenetic studies. Data from these studies will be used to guide the search for candidate biomarkers for diabetic end-organ damage in serum and urine and to identify mechanisms of diabetic kidney disease that may be amenable to new treatment strategies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01878045
|United States, Arizona|
|Phoenix, Arizona, United States, 85014|
|Principal Investigator:||Robert G Nelson, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|