Chicken-Diet vs. Enalapril to Reduce Albuminuria

This study has been completed.
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00484068
First received: June 6, 2007
Last updated: June 7, 2007
Last verified: June 2007
  Purpose

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.


Condition Intervention
Microalbuminuria
Diabetic Nephropathy
Drug: enalapril
Procedure: chicken diet

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

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

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

Enrollment: 28
Study Start Date: January 2003
Study Completion Date: June 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00484068

Locations
Brazil
HCPortoAlegre
Porto Alegre, RS, Brazil, , 90035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Jorge L Gross, MD Hospital de Clinicas de Porto Alegre
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00484068     History of Changes
Other Study ID Numbers: HCPA-98238
Study First Received: June 6, 2007
Last Updated: June 7, 2007
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
type 2 diabetes
microalbuminuria
chicken-based diet
ACE inhibitor

Additional relevant MeSH terms:
Albuminuria
Diabetic Nephropathies
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Kidney Diseases
Proteinuria
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Enalapril
Enalaprilat
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014