Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00484068
Status:
COMPLETED
Last Update Posted:
2007-06-08
First Post:
2007-06-06
Brief Title:
Chicken-Diet vs Enalapril to Reduce Albuminuria
Sponsor:
Hospital de Clinicas de Porto Alegre
Organization:
Hospital de Clinicas de Porto Alegre
Study Overview
Official Title:
Effect of Chicken-Based Diet Versus Enalapril on Albuminuria in Patients With Type 2 Diabetes and Microalbuminuria a One-Year Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2007-06
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:
Diabetic nephropathy DN is a chronic diabetic complication and affects up to 40 of patients The first line treatment for DN is angiotensin blockers drugs that are used to reduce the protein concentration in urinePrevious data showed that this protein namely albuminuria could also be reduced in a short term-period by the replacement of red meat in the diet with chicken The aim of this study is to compare the effects of this chicken diet with enalapril on albuminuria in a long-term period 12 monthsin type 2 diabetic patients
Detailed Description:
Replacement of red meat in the diet with chicken reduces urinary albumin excretion rate UAER and improves lipid profile in type 2 diabetic patients with micro- and macroalbuminuria in short term studies The aim of this study was to compare the long-term effect of a chicken-based diet CD versus enalapril treatment on renal function and lipid profile in microalbuminuric type 2 diabetic patients In this 12-month controlled clinical trial 28 patients were randomized to an experimental diet CD plus active placebo or enalapril treatment enalapril 10 mgday plus patients usual diet UAER immunoturbidimetry blood pressure levels anthropometric indices and compliance with the diet were evaluated monthly Glomerular filtration rate 51Cr-EDTA lipid glycemic and nutritional indices were measured at baseline and quarterly UAER was reduced after CD n13 628 384-1251 to 491 62-1465 mcgmin P0001 and after enalapril treatment n15 558 226-1943 to 231 40-1049 mcgmin P0001 The reduction of UAER was already significant at 4th month and there was no difference between the UAER reduction after CD 32 95 CI 67-576 and after enalapril treatment 447 95 CI 283-611 P0366 In conclusion CD and the ACE inhibitor enalapril promoted similar UAER reduction in patients with type 2 diabetes and microalbuminuria A chicken-based diet might represent an additional therapeutic approach to management of diabetic nephropathy
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