Chicken-Diet vs. Enalapril to Reduce Albuminuria

Diabetic Nephropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00484068
• Other study ID #: HCPA-98238
• Status: Completed
• Phase: N/A
• First received: June 6, 2007
• Last updated: June 7, 2007
• Start date: January 2003
• Est. completion date: June 2006

Study information

• Verified date: June 2007
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Albuminuria
• Diabetic Nephropathies
• Diabetic Nephropathy
• Microalbuminuria

Intervention

Drug:
• enalapril

Procedure:
• chicken diet

Locations

Country	Name	City	State
Brazil	HCPortoAlegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

de Mello VD, Zelmanovitz T, Perassolo MS, Azevedo MJ, Gross JL. Withdrawal of red meat from the usual diet reduces albuminuria and improves serum fatty acid profile in type 2 diabetes patients with macroalbuminuria. Am J Clin Nutr. 2006 May;83(5):1032-8. — View Citation

Gross JL, Zelmanovitz T, Moulin CC, De Mello V, Perassolo M, Leitão C, Hoefel A, Paggi A, Azevedo MJ. Effect of a chicken-based diet on renal function and lipid profile in patients with type 2 diabetes: a randomized crossover trial. Diabetes Care. 2002 Ap — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urinary albumin excretion		during study
Primary	serum lipids		during study
Primary	nutritional status		during study