The Effects of Weight Reduction in IgA Nephropathy

Proteinuria Clinical Trial

— WeightPro  

Official title:

The Effects of Weight Reduction in Chronic Proteinuric IgA Nephropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01773382
• Other study ID #: PK8197
• Status: Recruiting
• Phase: N/A
• First received: January 4, 2013
• Last updated: January 18, 2013
• Start date: October 2012
• Est. completion date: April 2013

Study information

• Verified date: January 2013
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• Proteinuria
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
Thailand	Faculty of medicine, Chulalongkorn university	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No