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 range

18 Years – 100 Years

Sex

ALL

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is listed as 'suspended' — can you find out why enrollment stopped and whether it's likely to resume, before I consider it as an option?
2Since this study focuses on American Indians with diabetic kidney disease, would my doctor consider me a good fit given my background and current kidney function?
3The trial is measuring end-stage renal disease as its primary outcome — does that mean it's mainly tracking disease progression rather than testing a treatment, and if so, how might participating actually benefit me compared to my current care plan?
4Given that this study involves the nervous system alongside kidney disease, what kinds of tests or procedures would I likely need to undergo, and how would that fit into my existing schedule of diabetes and kidney care?
5Are there standard treatments or other active clinical trials for diabetic kidney disease that my doctor thinks I should explore first, given that this one is currently suspended?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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