Delaying the Progression of Diabetic Nephropathy in Pima Indians
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Observational

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.
    

Detailed description: 
      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, -0.91 to -0.07), and 11 of them (8 men, 3 women) are
      hypertensive (systolic blood pressure greater than or equal to 140 mm Hg, diastolic blood
      pressure greater than or equal to 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.
    

Keywords: Proteinuria; Renal Failure; Angiotension Converting Enzyme Inhibitor; Glomerular Filtration Rate