Study checks if past drug still protects kidneys years later
NCT ID NCT01878045
First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 18 times
Summary
This study looks at American Indians with type 2 diabetes who had early kidney disease and took a drug called losartan years ago. Researchers want to see if the benefits of that treatment still help protect their kidneys today. About 141 people who were in the earlier study or their relatives with diabetes can join. No new treatment is given—only tests like blood draws, urine samples, and kidney scans.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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141 people
The number who actually took part.
- Started
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Nov 2013
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Participants in a clinical trial that is now completed and their first degree relatives with type 2 diabetes.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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 with antihypertensive medicines and the primary care physician or the patient refuses to adopt the blood pressure treatment regimen outlined in the study protocol. * Hematuria of unknown etiology. Prior to entry into the study, any subject with hematuria should be evaluated, the etiology established and documented, and treatment rendered as appropriate. * Chronic debilitating disorders with or without treatment (e.g., systemic lupus erythematosus (SLE), cancer, amyloidosis, and chronic infection) that would interfere with the assessment of kidney function. Participants who develop these disorders after their original enrollment into one of our kidney studies will continue to be followed in the protocol. * Currently receiving a drug regimen that includes: steroids, immunosuppressants, or investigational new drugs. Participants who receive these drugs following original enrollment into one of our kidney studies will continue to be followed in the protocol, unless they have known chronic significant effects on kidney morphology or a high incidence of adverse effects on kidney function, in which case they will be withdrawn from the study. * Pregnancy. Women of childbearing potential must have a negative pregnancy test prior to entry and prior to each renal clearance study. Women who are pregnant will be offered the opportunity to participate following the conclusion of the pregnancy and those who become pregnant during the study will be able to resume the study following the conclusion of the pregnancy. * Hypersensitivity to iodine. * Bleeding disorders, since kidney biopsies could not be performed safely in these individuals. * Massive obesity with body mass index greater than or equal to 45 kg/m(2). Kidney biopsies are more difficult and present greater hazards to persons with massive obesity. * Conditions likely to interfere with informed consent or compliance with the protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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NIDDK, Phoenix
Phoenix, Arizona, 85014, United States
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