The Effects of Weight Reduction in IgA Nephropathy

Not Applicable

• Conditions: Proteinuria
• Interventions: Behavioral: weight reduction

• Registration Number: NCT01773382
• Lead Sponsor: Chulalongkorn University

Brief Summary

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.

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.

Study Timeline

• Study Start: 2012-10
• Status Verified: 2013-01
• Study First Submitted: 2013-01-04
• Study First Submitted QC: 2013-01-18
• Last Update Submitted: 2013-01-18
• Study First Posted: 2013-01-23
• Last Update Posted: 2013-01-23
• Primary Completion: 2013-03
• Study Completion: 2013-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
weight reduction	weight reduction	target weight reduction is 3-5% from baseline

Primary Outcome Measures

Name	Time	Method
Percentage change of 24-hour proteinuria	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 Outcome Measures

Name	Time	Method
plasma concentration of IL-6, adiponectin, resistin, leptin, MCP-1	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.

Trial Locations

Locations (1)

Faculty of medicine, Chulalongkorn university; 🇹🇭 Bangkok, Thailand