Clinical Trial: Chicken-Diet vs. Enalapril to Reduce Albuminuria

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Hospital de Clinicas de Porto Alegre

Current Primary Outcome:

  • urinary albumin excretion [ Time Frame: during study ]
  • serum lipids [ Time Frame: during study ]
  • nutritional status [ Time Frame: during study ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Hospital de Clinicas de Porto Alegre

Dates:
Date Received: June 6, 2007
Date Started: January 2003
Date Completion:
Last Updated: June 7, 2007
Last Verified: June 2007