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Delaying the Progression of Diabetic Nephropathy in Pima Indians

NCT00353600 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2017-07-02

No results posted yet for this study

Summary

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.

Conditions

  • Diabetic Nephropathy

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1994-08-19
Completion
2011-08-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00353600 on ClinicalTrials.gov