Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340678
Status:
COMPLETED
Last Update Posted:
2021-03-25
First Post:
2006-06-19
Brief Title:
Renoprotection in Early 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:
Renoprotection in Early Diabetic Nephropathy in Pima Indians
Status:
COMPLETED
Status Verified Date:
2013-10
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:
This investigation is a randomized double-blinded placebo-controlled clinical trial in adult diabetic Pima Indians with normal urinary albumin excretion albumin-to-creatinine ration less than 30 mgg or microalbuminuria albumin-to-creatinine ration 30-299 mgg to test the hypothesis that blockade of the renin-angiotensin system with the angiotensin receptor blocker ARB losartan can prevent or further attenuate the development and progression of early diabetic nephropathy in subjects with type 2 diabetes mellitus who are receiving standard diabetes care
One hundred seventy subjects were recruited for the study all of whom had type 2 diabetes for at least 5 years serum creatinine concentrations less than 14 mgdl and no evidence of non-diabetic renal diseases Ninety-two of the subjects had normal urinary albumin excretion at baseline and other 78 had microalbuminuria Subjects in each albumin excretion group were randomized to treatment with either the angiotensin II receptor antagonist losartan or placebo Measurements of glomerular filtration rate GFR renal plasma flow RPF and fractional clearances of albumin and IgG will be made initially at one month and at 12-month intervals from baseline thereafter A kidney biopsy was performed after six years in 111 subjects Morphometric analysis of renal biopsies was used to determine differences in glomerular structure between treatment groups
One hundred seventy subjects were recruited for the study all of whom had type 2 diabetes for at least 5 years serum creatinine concentrations less than 14 mgdl and no evidence of non-diabetic renal diseases Ninety-two of the subjects had normal urinary albumin excretion at baseline and other 78 had microalbuminuria Subjects in each albumin excretion group were randomized to treatment with either the angiotensin II receptor antagonist losartan or placebo Measurements of glomerular filtration rate GFR renal plasma flow RPF and fractional clearances of albumin and IgG will be made initially at one month and at 12-month intervals from baseline thereafter A kidney biopsy was performed after six years in 111 subjects Morphometric analysis of renal biopsies was used to determine differences in glomerular structure between treatment groups
Detailed Description:
This investigation is a randomized double-blinded placebo-controlled clinical trial in adult diabetic Pima Indians with normal urinary albumin excretion albumin-to-creatinine ratio 30 mgg or microalbuminuria albumin-to-creatinine ratio 30-299 mgg to test the hypothesis that blockade of the renin-angiotensin system with the angiotensin receptor blocker ARB losartan can prevent or further attenuate the development and progression of early diabetic nephropathy in subjects with type 2 diabetes mellitus who are receiving standard diabetes care
One hundred seventy subjects were recruited for the study all of whom had type 2 diabetes for at least 5 years serum creatinine concentrations 14 mgdl and no evidence of non-diabetic renal diseases Ninety-two of the subjects had normal urinary albumin excretion at baseline and the other 78 had microalbuminuria Subjects in each albumin excretion group were randomized to treatment with either the angiotensin II receptor antagonist losartan or placebo Measurements of glomerular filtration rate GFR renal plasma flow RPF and fractional clearances of albumin and immunoglobulin G IgG were made initially at one month and at 12-month intervals from baseline thereafter A kidney biopsy was be performed after six years in 111 subjects Morphometric analysis of renal biopsies was used to determine differences in glomerular structure between treatment groups
The major outcome measure was a decline in GFR to less than or equal to 60 mlmin or to half the baseline value in subjects that enter the study with a GFR of 120 mlmin Other measures of renoprotection were assessed including group differences in 1 change in albumin excretion 2 change in serum creatinine concentration and 3 glomerular morphology in all subjects as outlined above
One hundred seventy subjects were recruited for the study all of whom had type 2 diabetes for at least 5 years serum creatinine concentrations 14 mgdl and no evidence of non-diabetic renal diseases Ninety-two of the subjects had normal urinary albumin excretion at baseline and the other 78 had microalbuminuria Subjects in each albumin excretion group were randomized to treatment with either the angiotensin II receptor antagonist losartan or placebo Measurements of glomerular filtration rate GFR renal plasma flow RPF and fractional clearances of albumin and immunoglobulin G IgG were made initially at one month and at 12-month intervals from baseline thereafter A kidney biopsy was be performed after six years in 111 subjects Morphometric analysis of renal biopsies was used to determine differences in glomerular structure between treatment groups
The major outcome measure was a decline in GFR to less than or equal to 60 mlmin or to half the baseline value in subjects that enter the study with a GFR of 120 mlmin Other measures of renoprotection were assessed including group differences in 1 change in albumin excretion 2 change in serum creatinine concentration and 3 glomerular morphology in all subjects as outlined above
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 |
|---|---|---|---|
| OH95-DK-N037 | OTHER | NIHNIDDK | None |