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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01773382
Other study ID # PK8197
Secondary ID
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


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
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