Delaying the Progression of Diabetic Nephropathy in Pima Indians

Completed

Conditions studied: Diabetic Nephropathy

In brief

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.

Key facts

Study ID

NCT00353600

Run by

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

People needed

25

Starts

1994-08-19

Expected to finish

2011-08-16

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• NIDDK, Phoenix — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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