The Effects of Weight Reduction in IgA Nephropathy (WeightPro)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Chulalongkorn University
Sponsor:
Information provided by (Responsible Party):
Talerngsak Kanjanabuch, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01773382
First received: January 4, 2013
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Proteinuria
Behavioral: weight reduction

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 30
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)
Arms Assigned Interventions
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 Name: controlled weight reduction program

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773382

Locations
Thailand
Faculty of medicine, Chulalongkorn university Recruiting
Bangkok, Thailand, 10330
Contact: Piyawan Kittiskulnam, M.D.    6622564251 ext 101    piyawankitti@gmail.com   
Sub-Investigator: Piyawan Kittiskulnam, M.D.         
Principal Investigator: Talerngsak Kanjanabuch, Ass. Prof.         
Sub-Investigator: Wiwat Chancharoenthana, M.D.         
Sponsors and Collaborators
Chulalongkorn University
Investigators
Study Director: Piyawan Kittiskulnam, M.D. Chulalongkorn University
  More Information

No publications provided

Responsible Party: Talerngsak Kanjanabuch, Kidney and metabolic research center, Faculty of medicine, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01773382     History of Changes
Other Study ID Numbers: PK8197
Study First Received: January 4, 2013
Last Updated: January 18, 2013
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Proteinuria
Glomerulonephritis, IGA
Kidney Diseases
Weight Loss
Glomerulonephritis
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Body Weight Changes
Body Weight

ClinicalTrials.gov processed this record on July 23, 2014