The Effects of Weight Reduction in IgA Nephropathy

Overview

The study aims to explore the non-pharmacological treatment of IgA nephropathy by weight reduction. The investigators hypothesized that benefits of weight loss may reduce proteinuria.

Full Title of Study: “The Effects of Weight Reduction in Chronic Proteinuric IgA Nephropathy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2013

Detailed Description

This is a prospective randomized study in adult IgA nephropathy. The investigators enrolled 30 patients who have proteinuria exceeds 1 g per day with biopsy proven IgA nephropathy. The experimental arm recieves the non-pharmacological treatment, weight reduction protocol. All patients in this arm must be reduce their body weight in 3-5 % from baseline as protocol. Another arm is control group which recieves standard treatment of IgA nephropathy including ACEIs/ARBs for blood pressure control (target < 130/80 mmHg). The primary outcome is proteinuria level. The secondary outcome is cytokines and inflammatory markers level including interleukin-6, resistin, adiponectin, leptin and monocyte chemoattractant protein-1.

Interventions

  • Behavioral: weight reduction
    • Set target daily energy requirement by nutritionist (25-30 Kcal/Kg/day minus 500 Kcal) Advice and encourage patients to do aerobic exercise at least 30 minutes/day for 4-5 days/weeks. Daily body weight measurement. Record food diary

Arms, Groups and Cohorts

  • No Intervention: control
    • standard treatment of IgA nephropathy including ACEI/ARB for blood pressure control (target BP <130/80 mmHg)
  • Experimental: weight reduction
    • target weight reduction is 3-5% from baseline

Clinical Trial Outcome Measures

Primary Measures

  • Percentage change of 24-hour proteinuria
    • Time Frame: 6 months
    • The investigators measure amount of 24-hour proteinuria at randomization peroid ( as baseline), first, third and sixth month. Then, investigators calculate the percentage reduction of proteinuria at different time points.

Secondary Measures

  • plasma concentration of IL-6, adiponectin, resistin, leptin, MCP-1
    • Time Frame: 6 months
    • The investigators measure amount of plasma concentration of IL-6, adiponectin, resistin, leptin, MCP-1 at randomization peroid ( as baseline) and sixth month. Then, investigators calculate the percentage reduction of these cytokines in 6 months peroid.

Participating in This Clinical Trial

Inclusion Criteria

  • Biopsy-proven IgA nephropathy – body mass index more than 23 Kg/m2 – 24 hours urine protein more than 1 g – estimated GFR more than 20 ml/min Exclusion Criteria:

  • pregnancy and lactation – rapidly renal function decline – crescent formation in renal biopsy more than 10%

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chulalongkorn University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Talerngsak Kanjanabuch, Kidney and metabolic research center, Faculty of medicine – Chulalongkorn University
  • Overall Official(s)
    • Piyawan Kittiskulnam, M.D., Study Director, Chulalongkorn University

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