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| Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00353600 |
Purpose
A clinical intervention will be performed in adult diabetic Pima Indians with proteinuria to determine if an angiotensin converting enzyme (ACE) inhibitor is effective in slowing the progression of renal disease in persons with overt diabetic nephropathy attributable to type 2 diabetes mellitus (NIDDM).
The study will be conducted in the Gila River Indian Community and include proteinuric subjects selected from the Diabetic Renal Disease Study (DRDS; NIH Protocol Number 88-DK-79) in whom glomerular function has been measured at six-monthly intervals for the past 48 months. Twenty-five subjects (12 men, 13 women) aged 31-64 years are eligible for this study. These subjects all have urinary albumin-to-creatinine rations >=300 mg/g (equivalent to 300 mg albumin/day), serum creatinine concentrations < 3.0 mg/dl, and no evidence of nondiabetic renal diseases. Their GFR slopes average -0.49 ml/min/month (95% confidence interval, -0.91 to -0.07), and 11 of them (8 men, 3 women) are hypertensive (systolic blood pressure >=140 mm Hg, diastolic blood pressure >=90 mm Hg).
Subjects will be treated with an ACE inhibitor, and measurements of glomerular filtration rate (GFR) and renal plasma flow (RPF) will be made at six monthly intervals until the subjects' progress to renal failure. GFR slope (ml.min/month) will be computed, and the slope prior to the initiation of an ACE inhibitor will be compared with that obtained during treatment.
| Condition |
|---|
|
Diabetic Nephropathy |
| Study Type: | Observational |
| Official Title: | Delaying the Progression of Diabetic Nephropathy in Pima Indians |
| Estimated Enrollment: | 25 |
| Study Start Date: | August 1994 |
| Estimated Primary Completion Date: | October 1999 (Final data collection date for primary outcome measure) |
A clinical intervention will be performed in adult diabetic Pima Indians with proteinuria to determine if an angiotensin converting enzyme (ACE) inhibitor is effective in slowing the progression of renal disease in persons with overt diabetic nephropathy attributable to type 2 diabetes mellitus.
The study will be conducted in the Gila River Indian Community and include proteinuric subjects selected from the Diabetic Renal Disease Study (DRDS; NIH Protocol Number 88-DK-79) in whom glomerular function has been measured at six-monthly intervals for the past 48 months. Twenty-five subjects (12 men, 13 women) aged 31-64 years are eligible for this study. These subjects all have urinary albumin-to-creatinine ratios greater than or equal to 300 mg/g (equivalent to 300 mg albumin/day), serum creatinine concentrations less than 3.0 mg/dl, and no evidence of nondiabetic renal diseases. Their GFR slopes average -0.49 ml/min/month (95 percent confidence interval,
Subjects will be treated with an ACE inhibitor, and measurements of glomerular filtration rate (GFR) and renal plasma flow (RPF) will be made at six monthly intervals until the subjects' progress to renal failure. GFR slope (ml/min/month) will be computed, and the slope prior to the initiation of an ACE inhibitor will be compared with that obtained during treatment.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
To be eligible for participation in the study, subjects must meet the following criteria:
Previous completion of the DRDS;
Serum creatinine concentration less than 3.0 mg/dl;
Serum potassium concentration less than or equal to 5.7 mEq/L;
At least 2 of 3 screening urinary albumin-to-creatinine ratios greater than or equal to 300 mg/g;
Willingness, after receiving a thorough explanation of the study, to participate.
Severe hypertension will not affect eligibility for the study.
EXCLUSION CRITERIA:
In addition to the criteria outlined in the DRDS protocol, subjects with the following characteristics will be excluded:
Pregnancy. Women of childbearing age and not surgically sterilized must have a negative pregnancy test prior to entry and prior to each renal clearance study.
Hypersensitivity to ACE inhibitors.
Conditions that are likely to interfere with informed consent or compliance with the protocol.
Contacts and Locations More Information
| Study ID Numbers: | 999994034, OH94-DK-N034 |
| Study First Received: | July 17, 2006 |
| Last Updated: | September 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00353600 History of Changes |
| Health Authority: | United States: Federal Government |
|
Proteinuria Renal Failure Angiotension Converting Enzyme Inhibitor Glomerular Filtration Rate |
|
Proteinuria Diabetic Nephropathies Urologic Diseases Diabetes Mellitus Disease Progression |
Endocrine System Diseases Endocrinopathy Kidney Diseases Diabetes Complications Kidney Failure |
|
Diabetic Nephropathies Urologic Diseases Diabetes Mellitus |
Endocrine System Diseases Kidney Diseases Diabetes Complications |
