The Effects of Weight Reduction in IgA Nephropathy (WeightPro)

January 18, 2013 updated by: Talerngsak Kanjanabuch, Chulalongkorn University

The Effects of Weight Reduction in Chronic Proteinuric IgA Nephropathy

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Recruiting
        • Faculty of Medicine, Chulalongkorn University
        • Contact:
        • Sub-Investigator:
          • Piyawan Kittiskulnam, M.D.
        • Principal Investigator:
          • Talerngsak Kanjanabuch, Ass. Prof.
        • Sub-Investigator:
          • Wiwat Chancharoenthana, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
  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
Other Names:
  • controlled weight reduction program

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Study Director: Piyawan Kittiskulnam, M.D., Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

April 1, 2013

Study Registration Dates

First Submitted

January 4, 2013

First Submitted That Met QC Criteria

January 18, 2013

First Posted (Estimate)

January 23, 2013

Study Record Updates

Last Update Posted (Estimate)

January 23, 2013

Last Update Submitted That Met QC Criteria

January 18, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PK8197

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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