Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-01-02 @ 8:54 AM
Study NCT ID:
NCT00484068
Status:
COMPLETED
Last Update Posted:
2007-06-08
First Post:
2007-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chicken-Diet vs. Enalapril to Reduce Albuminuria
Sponsor:
Hospital de Clinicas de Porto Alegre
Organization:
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 urine.Previous 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 months)in 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 mg/day plus patient's 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 \[n=13; 62.8 (38.4-125.1) to 49.1 (6.2-146.5) mcg/min; P\<0.001\] and after enalapril treatment \[n=15; 55.8 (22.6-194.3) to 23.1 (4.0-104.9) mcg/min; P\<0.001\]. The reduction of UAER was already significant at 4th month, and there was no difference between the UAER reduction after CD \[32% (95% CI: 6.7-57.6) and after enalapril treatment \[44.7% (95% CI: 28.3-61.1); P=0.366\]. 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:
False
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?: