The Effects of Weight Reduction in IgA Nephropathy (WeightPro)
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effects of Weight Reduction in Chronic Proteinuric IgA Nephropathy|
- Percentage change of 24-hour proteinuria [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
- plasma concentration of IL-6, adiponectin, resistin, leptin, MCP-1 [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
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
Behavioral: weight reduction
Other Name: controlled weight reduction program
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01773382
|Faculty of medicine, Chulalongkorn university||Recruiting|
|Bangkok, Thailand, 10330|
|Contact: Piyawan Kittiskulnam, M.D. 6622564251 ext 101 email@example.com|
|Sub-Investigator: Piyawan Kittiskulnam, M.D.|
|Principal Investigator: Talerngsak Kanjanabuch, Ass. Prof.|
|Sub-Investigator: Wiwat Chancharoenthana, M.D.|
|Study Director:||Piyawan Kittiskulnam, M.D.||Chulalongkorn University|