Chicken-Diet vs. Enalapril to Reduce Albuminuria

NCT00484068 | Completed

• 1 other identifier: HCPA-98238
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Microalbuminuria; Diabetic Nephropathy

Keywords

type 2 diabetes; microalbuminuria; chicken-based diet; ACE inhibitor

Outcome Measures

Primary Outcomes (3)

• urinary albumin excretion

  during study

• serum lipids

  during study

• nutritional status

  during study

Interventions

enalapril DRUG

chicken diet PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

HCPortoAlegre

Porto Alegre, Rio Grande do Sul, , 90035-903, Brazil

Location

Related Publications (2)

• Gross JL, Zelmanovitz T, Moulin CC, De Mello V, Perassolo M, Leitao 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 Apr;25(4):645-51. doi: 10.2337/diacare.25.4.645.

  PMID: 11919119 RESULT

• 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. doi: 10.1093/ajcn/83.5.1032.

  PMID: 16685043 RESULT

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetes Mellitus, Type 2

Interventions

Enalapril

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jorge L Gross, MD

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 6, 2007
• First Posted: June 8, 2007
• Study Start: January 1, 2003
• Study Completion: June 1, 2006
• Last Updated: June 8, 2007

Record last verified: 2007-06

Locations

BR (1)