Status:
SUSPENDED
Mechanisms of Diabetic Kidney Disease in American Indians
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Nervous System
Diabetic Kidney Disease
Eligibility:
All Genders
18-100 years
Brief 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 pre...
Detailed Description
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 di...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 7 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT01878045
Start Date
November 7 2013
Last Update
December 17 2025
Active Locations (1)
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1
NIDDK, Phoenix
Phoenix, Arizona, United States, 85014