Chicken-Diet vs. Enalapril to Reduce Albuminuria

Not Applicable

Completed

• Conditions: Microalbuminuria; Diabetic Nephropathy

• Registration Number: NCT00484068
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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 Timeline

• Study Start: 2003-01
• Study Completion: 2006-06
• Status Verified: 2007-06
• Study First Submitted: 2007-06-06
• Study First Submitted QC: 2007-06-07
• Last Update Submitted: 2007-06-07
• Study First Posted: 2007-06-08
• Last Update Posted: 2007-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Patients with type 2 diabetes mellitus (according to World Health Organization criteria) attending the Endocrine Division's outpatient clinic at Hospital de Clínicas de Porto Alegre, Brazil. Patients were selected according to the following criteria: age <75 years, A1c <10%, 24-hour UAER 20 mcg/min and 199 mcg/min confirmed at least twice in a 6-month period, serum triglycerides <400 mg/dl and normal liver and thyroid function tests.

Exclusion Criteria

• Patients were excluded from the study if they had BMI >34 kg/m2, serum creatinine >1.5 mg/dl, repeated episodes of urinary tract infection, other renal diseases, symptomatic autonomic neuropathy, heart failure, and acute myocardial infarction, coronary artery revascularization procedures or stroke within the last 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
serum lipids	during study
nutritional status	during study
urinary albumin excretion	during study

Trial Locations

Locations (1)

HCPortoAlegre; 🇧🇷 Porto Alegre, RS, Brazil