Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353600
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-07-17
Brief Title:
Delaying the Progression of Diabetic Nephropathy in Pima Indians
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Delaying the Progression of Diabetic Nephropathy in Pima Indians
Status:
COMPLETED
Status Verified Date:
2011-08-16
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mgg equivalent to 300 mg albuminday serum creatinine concentrations 30 mgdl and no evidence of nondiabetic renal diseases Their GFR slopes average -049 mlminmonth 95 confidence interval -091 to -007 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 mlminmonth will be computed and the slope prior to the initiation of an ACE inhibitor will be compared with that obtained during treatment
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 mgg equivalent to 300 mg albuminday serum creatinine concentrations 30 mgdl and no evidence of nondiabetic renal diseases Their GFR slopes average -049 mlminmonth 95 confidence interval -091 to -007 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 mlminmonth 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 mgg equivalent to 300 mg albuminday serum creatinine concentrations less than 30 mgdl and no evidence of nondiabetic renal diseases Their GFR slopes average -049 mlminmonth 95 percent confidence interval -091 to -007 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 mlminmonth will be computed and the slope prior to the initiation of an ACE inhibitor will be compared with that obtained during treatment
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 mgg equivalent to 300 mg albuminday serum creatinine concentrations less than 30 mgdl and no evidence of nondiabetic renal diseases Their GFR slopes average -049 mlminmonth 95 percent confidence interval -091 to -007 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 mlminmonth will be computed and the slope prior to the initiation of an ACE inhibitor will be compared with that obtained during treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OH94-DK-N034 | None | None | None |