The Effects of Weight Reduction in IgA Nephropathy
WeightPro
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 4, 2013
CompletedFirst Posted
Study publicly available on registry
January 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedJanuary 23, 2013
January 1, 2013
5 months
January 4, 2013
January 18, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
plasma concentration of IL-6, adiponectin, resistin, leptin, MCP-1
6 months
Study Arms (2)
control
NO INTERVENTIONstandard treatment of IgA nephropathy including ACEI/ARB for blood pressure control (target BP \<130/80 mmHg)
weight reduction
EXPERIMENTALtarget weight reduction is 3-5% from baseline
Interventions
1. Set target daily energy requirement by nutritionist (25-30 Kcal/Kg/day minus 500 Kcal) 2. Advice and encourage patients to do aerobic exercise at least 30 minutes/day for 4-5 days/weeks. 3. Daily body weight measurement. 4. Record food diary
Eligibility Criteria
You may qualify if:
- Biopsy-proven IgA nephropathy
- body mass index more than 23 Kg/m2
- hours urine protein more than 1 g
- estimated GFR more than 20 ml/min
You may not qualify if:
- pregnancy and lactation
- rapidly renal function decline
- crescent formation in renal biopsy more than 10%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of medicine, Chulalongkorn university
Bangkok, Bangkok, 10330, Thailand
Related Publications (2)
Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
PMID: 38299639DERIVEDConley MM, McFarlane CM, Johnson DW, Kelly JT, Campbell KL, MacLaughlin HL. Interventions for weight loss in people with chronic kidney disease who are overweight or obese. Cochrane Database Syst Rev. 2021 Mar 30;3(3):CD013119. doi: 10.1002/14651858.CD013119.pub2.
PMID: 33782940DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Piyawan Kittiskulnam, M.D.
Chulalongkorn University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Kidney and metabolic research center, Faculty of medicine
Study Record Dates
First Submitted
January 4, 2013
First Posted
January 23, 2013
Study Start
October 1, 2012
Primary Completion
March 1, 2013
Study Completion
April 1, 2013
Last Updated
January 23, 2013
Record last verified: 2013-01