Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118976
Status:
COMPLETED
Last Update Posted:
2006-11-23
First Post:
2005-07-01
Brief Title:
Maximal Dose of Angiotensin Converting Enzyme ACE Inhibitor for Treatment of Diabetic Kidney Disease
Sponsor:
Steno Diabetes Center Copenhagen
Organization:
Steno Diabetes Center Copenhagen
Study Overview
Official Title:
Optimal Dose of ACE Inhibitor for Treatment of Diabetic Nephropathy in Type 1 Diabetic Patients With Hypertension and Diabetic Nephropathy
Status:
COMPLETED
Status Verified Date:
2006-11
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:
The primary aim is to evaluate the anti proteinuric effect of increasing doses of the ACE inhibitor lisinopril 20 40 and 60 mg daily in type 1 diabetic patients with hypertension and diabetic nephropathy
The secondary aim is to evaluate the effect on blood pressure 24 hour ambulatory blood pressure and kidney function glomerular filtration rate GFR
The tertiary aim is to evaluate differences in response to treatment according to ACEinsertiondeletion ID-genotypes and other genetic variants in the genes of the renin angiotensin system
The secondary aim is to evaluate the effect on blood pressure 24 hour ambulatory blood pressure and kidney function glomerular filtration rate GFR
The tertiary aim is to evaluate differences in response to treatment according to ACEinsertiondeletion ID-genotypes and other genetic variants in the genes of the renin angiotensin system
Detailed Description:
This is a randomized double-blind cross-over study with three treatment periods consisting of 20 40 and 60 mg lisinopril daily in random order The endpoints of the study will be examined after each treatment period There is no wash out between treatment periods To minimize the risk of hypotension every treatment period starts with 20 mg lisinopril for two weeks Thus the risk of adverse effects is minimized and an increase in dose from 0 mg to 60 mg lisinopril is avoided
The patients usual antihypertensive treatments will be stopped in a period of 8 weeks wash out before randomization Since diuretic drugs will be needed by almost every patient in the study to avoid oedema all patients will be treated with lasix retard 60 - 120 mg daily
Patients
60 type 1 diabetic patients with diabetic nephropathy and hypertension blood pressure 135 mm Hg systolic andor 85 mm Hg diastolic
Methods
The endpoints of the study will be examined at baseline and after each treatment period corresponding to 8 16 and 24 weeks after randomization The following parameters are determined after each treatment period Albuminuria determined from three consecutive 24 hours urine collections kidney function GFR - by plasma clearance of 51Cr-EDTA and 24 hour ambulatory blood pressure TM-24202421 Furthermore the concentrations of TGF-ß sodium creatinine and carbamide in the 24 hour urinary samples are determined The plasma concentration of albumin renin angiotensin II and aldosterone is measured
DNA is extracted from a blood sample and genetic variants in the renin-angiotensin system are measured including the ACEID genotype
Endpoints
Primary endpoint albuminuria Secondary endpoints blood pressure 24 hour ambulatory and GFR Tertiary differences in response to treatment in patients with different ACEID and other renin angiotensin system genotypes
The patients usual antihypertensive treatments will be stopped in a period of 8 weeks wash out before randomization Since diuretic drugs will be needed by almost every patient in the study to avoid oedema all patients will be treated with lasix retard 60 - 120 mg daily
Patients
60 type 1 diabetic patients with diabetic nephropathy and hypertension blood pressure 135 mm Hg systolic andor 85 mm Hg diastolic
Methods
The endpoints of the study will be examined at baseline and after each treatment period corresponding to 8 16 and 24 weeks after randomization The following parameters are determined after each treatment period Albuminuria determined from three consecutive 24 hours urine collections kidney function GFR - by plasma clearance of 51Cr-EDTA and 24 hour ambulatory blood pressure TM-24202421 Furthermore the concentrations of TGF-ß sodium creatinine and carbamide in the 24 hour urinary samples are determined The plasma concentration of albumin renin angiotensin II and aldosterone is measured
DNA is extracted from a blood sample and genetic variants in the renin-angiotensin system are measured including the ACEID genotype
Endpoints
Primary endpoint albuminuria Secondary endpoints blood pressure 24 hour ambulatory and GFR Tertiary differences in response to treatment in patients with different ACEID and other renin angiotensin system genotypes
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