SuspendedNot Applicable

Mechanisms of Diabetic Kidney Disease in American Indians

Stopped: This study is on a temporary Administrative Hold pending further discussion for NIDDK and Tribal Leadership.

United States141 participantsStarted 2013-11-07

Plain-language summary

Background: \- 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. Objectives: \- To study long-term benefit of losartan treatment for diabetic kidney disease in American Indians with type 2 diabetes. Eligibility: \- Participants in the American Indian diabetic kidney disease study (OH95-DK-N037). Design: * 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.

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: To be eligible for participation in the study, subjects must meet the following criteria: * Previous enrollment in protocol OH95-DK-N037 or a first-degree relative of an enrollee who is aged greater than or equal to 18 years and has type 2 diabetes. * Willingness, after receiving a thorough explanation of the study, to participate. EXCLUSION CRITERIA: Subjects will be excluded for the following reasons: * Clinically significant disorders of the liver \[cirrhosis, portal hypertension, hepatitis, increased bilirubin (greater than or equal to 1.5 mg/dl), cardiovascular disease (angina pectoris, history of myocardial infarction, left ventricular ejection fraction \<40%, congestive heart failure of New York Heart Association Class I to IV), cerebrovascular disease, peripheral vascular disease, pulmonary diseases (asthma and restrictive or obstructive lung disease requiring therapy), renal-urinary disorders (calculi, urinary tract obstruction, glomerulonephritis, chronic infection), gastrointestinal disorders (nausea, vomiting, diarrhea or anorexia sufficient to cause weight loss or wasting), or hematocrit levels less than or equal to 30 percent in women or less than or equal to 35 percent in men. * Renovascular or malignant hypertension; uncontrolled hypertension (systolic blood pressure greater than or equal to 160 or diastolic greater than or equal to 95 mm Hg) despite treatment with three antihypertensive drugs; or hypertension that is being treated w…

What they're measuring

End-Stage Renal Disease

Timeframe: Continuous surveillance performed independent of the research examinations

Trial details

NCT IDNCT01878045

SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2019-07-02