A controlled clinical trial of angiotensin-converting enzyme inhibition in type I diabetic nephropathy

Study design and patient characteristics

Ray Bain, Richard Rohde, Lawrence G. Hunsicker, Janet McGill, Sidney Kobrin, Edmund J. Lewis, John Lachin, Jay Wish, John Sheehan, Marc Pohl, Tomas Berl, Godofredo Santiago, Jacob Lemann, Samuel Blumenthal, Lee Hebert, Norris Stanley Nahman, Stanley Goldfarb, Mohammad Sikder, Roger Rodby, Andrew Levey & 20 others Mark Williams, Frederick Whittier, Daniel Cattran, Stephen Lietz, Daiva Valaitis, Jesse Hano, Douglas Maxwell, Jerome Porush, Samuel Spitalewitz, Kenneth Shapiro, Sharon Adler, Nathan Tolchin, Wendy Hoy, Robert Bernstein, Laura Svetkey, Zeev Sharon, Peter Lodewick, Hugh Tildesley, Nadir Farid, Julia Breyer

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

A placebo-controlled, double-blind clinical trial has been initiated to determine whether angiotensin-converting enzyme inhibitor (ACEI) therapy with captopril (25 mg three times daily) slows the progressive loss of renal function in patients with type 1 diabetes mellitus. Entry criteria include; (1) ages 18 to 50 yr; (2) onset of insulin-dependent diabetes before the age of 30 yr, insulin dependent for at least 7 yr; (3) 24-h urine protein excretion >500 mg, plus: (a) diabetic retinopathy or (b) if no retinopathy, a renal biopsy diagnosis of diabetic nephropathy; (4) serum creatinine (SCr) <2.5 mg/dL; (5) informed consent. Patients follow strict medical management protocols. Systemic blood pressure is controlled to predefined goals (<140-90 mm Hg). The primary outcome of the Study is a doubling of the patients' entry SCr to at least 2 mg/dL confirmed by a >50% decrease in GFR by radioactive iothalamate clearance technique. Baseline characteristics of the cohort at entry into the Study are (mean ±SD): male/female, 52%/48%; age, 35 ± 8 yr; duration of diabetes, 21 ± 7 yr; duration of proteinuria, 2.8 ± 3.3 yr; duration of retinopathy, 4.5 ± 4.1 yr; 50% of cohort presented with hypertension, duration, 4 ± 4.7 yr; blood pressure, 139/86 ± 19/12; SCr, 1.35 ± 0.44 mg/dL; GFR 78 ± 32 mL/min; BUN, 24 ± 11 mg/dL; proteinuria, 3.1 ± 3.3 g/day; cholesterol, 236 ± 50 mg/dL; total glycosylated hemoglobin, 11.1 ± 2.1%. Analysis of baseline data with entry GFR yielded the following univariate linear associations: GFR had a weak but significant inverse correlation with urine protein/creatinine ratio (r 2 = 0.19), entry systolic blood pressure (-0.62 mL/min/1.73 m 2 /mm Hg; r 2 = 0.13), age at entry (-1.2 mL/min/yr; r 2 = 0.07), and serum cholesterol (r 2 = 0.09). GFR was not correlated with duration of diabetes (r 2 = 0.006), percentage of life as a diabetic (r 2 = 0.02), or blood glycohemoglobin (r 2 = 0.007). The elements of a controlled clinical trial are described. The baseline entry data confirm an association between reduced GFR and increasing hypertension, proteinuria, and cholesterolemia but not duration of diabetes, percentage of life as a diabetic, or severity of hyperglycemia.

Original languageEnglish (US)
JournalJournal of the American Society of Nephrology
Volume3
Issue number4 SUPPL.
StatePublished - Oct 1 1992

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Controlled Clinical Trials
Diabetic Nephropathies
Peptidyl-Dipeptidase A
Proteinuria
Creatinine
Blood Pressure
Serum
Cholesterol
Iothalamic Acid
Urine
Insulin
Hypertension
Enzyme Therapy
Kidney
Blood Urea Nitrogen
Captopril
Glycosylated Hemoglobin A
Diabetic Retinopathy
Type 1 Diabetes Mellitus
Angiotensin-Converting Enzyme Inhibitors

Keywords

  • Angiotensin-converting enzyme inhibition
  • Captopril
  • Diabetes mellitus
  • Diabetic nephropathy

ASJC Scopus subject areas

  • Nephrology

Cite this

A controlled clinical trial of angiotensin-converting enzyme inhibition in type I diabetic nephropathy : Study design and patient characteristics. / Bain, Ray; Rohde, Richard; Hunsicker, Lawrence G.; McGill, Janet; Kobrin, Sidney; Lewis, Edmund J.; Lachin, John; Wish, Jay; Sheehan, John; Pohl, Marc; Berl, Tomas; Santiago, Godofredo; Lemann, Jacob; Blumenthal, Samuel; Hebert, Lee; Nahman, Norris Stanley; Goldfarb, Stanley; Sikder, Mohammad; Rodby, Roger; Levey, Andrew; Williams, Mark; Whittier, Frederick; Cattran, Daniel; Lietz, Stephen; Valaitis, Daiva; Hano, Jesse; Maxwell, Douglas; Porush, Jerome; Spitalewitz, Samuel; Shapiro, Kenneth; Adler, Sharon; Tolchin, Nathan; Hoy, Wendy; Bernstein, Robert; Svetkey, Laura; Sharon, Zeev; Lodewick, Peter; Tildesley, Hugh; Farid, Nadir; Breyer, Julia.

In: Journal of the American Society of Nephrology, Vol. 3, No. 4 SUPPL., 01.10.1992.

Research output: Contribution to journalArticle

Bain, R, Rohde, R, Hunsicker, LG, McGill, J, Kobrin, S, Lewis, EJ, Lachin, J, Wish, J, Sheehan, J, Pohl, M, Berl, T, Santiago, G, Lemann, J, Blumenthal, S, Hebert, L, Nahman, NS, Goldfarb, S, Sikder, M, Rodby, R, Levey, A, Williams, M, Whittier, F, Cattran, D, Lietz, S, Valaitis, D, Hano, J, Maxwell, D, Porush, J, Spitalewitz, S, Shapiro, K, Adler, S, Tolchin, N, Hoy, W, Bernstein, R, Svetkey, L, Sharon, Z, Lodewick, P, Tildesley, H, Farid, N & Breyer, J 1992, 'A controlled clinical trial of angiotensin-converting enzyme inhibition in type I diabetic nephropathy: Study design and patient characteristics', Journal of the American Society of Nephrology, vol. 3, no. 4 SUPPL..
Bain, Ray ; Rohde, Richard ; Hunsicker, Lawrence G. ; McGill, Janet ; Kobrin, Sidney ; Lewis, Edmund J. ; Lachin, John ; Wish, Jay ; Sheehan, John ; Pohl, Marc ; Berl, Tomas ; Santiago, Godofredo ; Lemann, Jacob ; Blumenthal, Samuel ; Hebert, Lee ; Nahman, Norris Stanley ; Goldfarb, Stanley ; Sikder, Mohammad ; Rodby, Roger ; Levey, Andrew ; Williams, Mark ; Whittier, Frederick ; Cattran, Daniel ; Lietz, Stephen ; Valaitis, Daiva ; Hano, Jesse ; Maxwell, Douglas ; Porush, Jerome ; Spitalewitz, Samuel ; Shapiro, Kenneth ; Adler, Sharon ; Tolchin, Nathan ; Hoy, Wendy ; Bernstein, Robert ; Svetkey, Laura ; Sharon, Zeev ; Lodewick, Peter ; Tildesley, Hugh ; Farid, Nadir ; Breyer, Julia. / A controlled clinical trial of angiotensin-converting enzyme inhibition in type I diabetic nephropathy : Study design and patient characteristics. In: Journal of the American Society of Nephrology. 1992 ; Vol. 3, No. 4 SUPPL.
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keywords = "Angiotensin-converting enzyme inhibition, Captopril, Diabetes mellitus, Diabetic nephropathy",
author = "Ray Bain and Richard Rohde and Hunsicker, {Lawrence G.} and Janet McGill and Sidney Kobrin and Lewis, {Edmund J.} and John Lachin and Jay Wish and John Sheehan and Marc Pohl and Tomas Berl and Godofredo Santiago and Jacob Lemann and Samuel Blumenthal and Lee Hebert and Nahman, {Norris Stanley} and Stanley Goldfarb and Mohammad Sikder and Roger Rodby and Andrew Levey and Mark Williams and Frederick Whittier and Daniel Cattran and Stephen Lietz and Daiva Valaitis and Jesse Hano and Douglas Maxwell and Jerome Porush and Samuel Spitalewitz and Kenneth Shapiro and Sharon Adler and Nathan Tolchin and Wendy Hoy and Robert Bernstein and Laura Svetkey and Zeev Sharon and Peter Lodewick and Hugh Tildesley and Nadir Farid and Julia Breyer",
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T1 - A controlled clinical trial of angiotensin-converting enzyme inhibition in type I diabetic nephropathy

T2 - Study design and patient characteristics

AU - Bain, Ray

AU - Rohde, Richard

AU - Hunsicker, Lawrence G.

AU - McGill, Janet

AU - Kobrin, Sidney

AU - Lewis, Edmund J.

AU - Lachin, John

AU - Wish, Jay

AU - Sheehan, John

AU - Pohl, Marc

AU - Berl, Tomas

AU - Santiago, Godofredo

AU - Lemann, Jacob

AU - Blumenthal, Samuel

AU - Hebert, Lee

AU - Nahman, Norris Stanley

AU - Goldfarb, Stanley

AU - Sikder, Mohammad

AU - Rodby, Roger

AU - Levey, Andrew

AU - Williams, Mark

AU - Whittier, Frederick

AU - Cattran, Daniel

AU - Lietz, Stephen

AU - Valaitis, Daiva

AU - Hano, Jesse

AU - Maxwell, Douglas

AU - Porush, Jerome

AU - Spitalewitz, Samuel

AU - Shapiro, Kenneth

AU - Adler, Sharon

AU - Tolchin, Nathan

AU - Hoy, Wendy

AU - Bernstein, Robert

AU - Svetkey, Laura

AU - Sharon, Zeev

AU - Lodewick, Peter

AU - Tildesley, Hugh

AU - Farid, Nadir

AU - Breyer, Julia

PY - 1992/10/1

Y1 - 1992/10/1

N2 - A placebo-controlled, double-blind clinical trial has been initiated to determine whether angiotensin-converting enzyme inhibitor (ACEI) therapy with captopril (25 mg three times daily) slows the progressive loss of renal function in patients with type 1 diabetes mellitus. Entry criteria include; (1) ages 18 to 50 yr; (2) onset of insulin-dependent diabetes before the age of 30 yr, insulin dependent for at least 7 yr; (3) 24-h urine protein excretion >500 mg, plus: (a) diabetic retinopathy or (b) if no retinopathy, a renal biopsy diagnosis of diabetic nephropathy; (4) serum creatinine (SCr) <2.5 mg/dL; (5) informed consent. Patients follow strict medical management protocols. Systemic blood pressure is controlled to predefined goals (<140-90 mm Hg). The primary outcome of the Study is a doubling of the patients' entry SCr to at least 2 mg/dL confirmed by a >50% decrease in GFR by radioactive iothalamate clearance technique. Baseline characteristics of the cohort at entry into the Study are (mean ±SD): male/female, 52%/48%; age, 35 ± 8 yr; duration of diabetes, 21 ± 7 yr; duration of proteinuria, 2.8 ± 3.3 yr; duration of retinopathy, 4.5 ± 4.1 yr; 50% of cohort presented with hypertension, duration, 4 ± 4.7 yr; blood pressure, 139/86 ± 19/12; SCr, 1.35 ± 0.44 mg/dL; GFR 78 ± 32 mL/min; BUN, 24 ± 11 mg/dL; proteinuria, 3.1 ± 3.3 g/day; cholesterol, 236 ± 50 mg/dL; total glycosylated hemoglobin, 11.1 ± 2.1%. Analysis of baseline data with entry GFR yielded the following univariate linear associations: GFR had a weak but significant inverse correlation with urine protein/creatinine ratio (r 2 = 0.19), entry systolic blood pressure (-0.62 mL/min/1.73 m 2 /mm Hg; r 2 = 0.13), age at entry (-1.2 mL/min/yr; r 2 = 0.07), and serum cholesterol (r 2 = 0.09). GFR was not correlated with duration of diabetes (r 2 = 0.006), percentage of life as a diabetic (r 2 = 0.02), or blood glycohemoglobin (r 2 = 0.007). The elements of a controlled clinical trial are described. The baseline entry data confirm an association between reduced GFR and increasing hypertension, proteinuria, and cholesterolemia but not duration of diabetes, percentage of life as a diabetic, or severity of hyperglycemia.

AB - A placebo-controlled, double-blind clinical trial has been initiated to determine whether angiotensin-converting enzyme inhibitor (ACEI) therapy with captopril (25 mg three times daily) slows the progressive loss of renal function in patients with type 1 diabetes mellitus. Entry criteria include; (1) ages 18 to 50 yr; (2) onset of insulin-dependent diabetes before the age of 30 yr, insulin dependent for at least 7 yr; (3) 24-h urine protein excretion >500 mg, plus: (a) diabetic retinopathy or (b) if no retinopathy, a renal biopsy diagnosis of diabetic nephropathy; (4) serum creatinine (SCr) <2.5 mg/dL; (5) informed consent. Patients follow strict medical management protocols. Systemic blood pressure is controlled to predefined goals (<140-90 mm Hg). The primary outcome of the Study is a doubling of the patients' entry SCr to at least 2 mg/dL confirmed by a >50% decrease in GFR by radioactive iothalamate clearance technique. Baseline characteristics of the cohort at entry into the Study are (mean ±SD): male/female, 52%/48%; age, 35 ± 8 yr; duration of diabetes, 21 ± 7 yr; duration of proteinuria, 2.8 ± 3.3 yr; duration of retinopathy, 4.5 ± 4.1 yr; 50% of cohort presented with hypertension, duration, 4 ± 4.7 yr; blood pressure, 139/86 ± 19/12; SCr, 1.35 ± 0.44 mg/dL; GFR 78 ± 32 mL/min; BUN, 24 ± 11 mg/dL; proteinuria, 3.1 ± 3.3 g/day; cholesterol, 236 ± 50 mg/dL; total glycosylated hemoglobin, 11.1 ± 2.1%. Analysis of baseline data with entry GFR yielded the following univariate linear associations: GFR had a weak but significant inverse correlation with urine protein/creatinine ratio (r 2 = 0.19), entry systolic blood pressure (-0.62 mL/min/1.73 m 2 /mm Hg; r 2 = 0.13), age at entry (-1.2 mL/min/yr; r 2 = 0.07), and serum cholesterol (r 2 = 0.09). GFR was not correlated with duration of diabetes (r 2 = 0.006), percentage of life as a diabetic (r 2 = 0.02), or blood glycohemoglobin (r 2 = 0.007). The elements of a controlled clinical trial are described. The baseline entry data confirm an association between reduced GFR and increasing hypertension, proteinuria, and cholesterolemia but not duration of diabetes, percentage of life as a diabetic, or severity of hyperglycemia.

KW - Angiotensin-converting enzyme inhibition

KW - Captopril

KW - Diabetes mellitus

KW - Diabetic nephropathy

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