The Effects of Weight Reduction in IgA Nephropathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Weight Reduction in Chronic Proteinuric IgA Nephropathy

Conditions
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Proteinuria

Intervention / Treatment
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* Behavioral: weight reduction


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>standard treatment of IgA nephropathy including ACEI/ARB for blood pressure control (target BP <130/80 mmHg) | |
| Experimental: weight reduction<br>target weight reduction is 3-5% from baseline | Behavioral: weight reduction<br>* 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<br>* Other names: controlled weight reduction program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change of 24-hour proteinuria | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma concentration of IL-6, adiponectin, resistin, leptin, MCP-1 | 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. | 6 months |