Effect of diacerein on kidney function, glucose and blod fat metabolism alteration and acute inflamation indicators in type 2 diabetic patients with kidney disease

Phase 3

• Conditions: Mellitus DiabetesDiabetic nephropathyKidney Failure, Chronic; E10-E14; E11.2; C12.777.419.780.750.500

• Registration Number: RBR-2tfwq3
• Lead Sponsor: niversidade Federal do Rio Grande do Sul

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-07
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients from 30 to 80 years old, with type 2 diabetic with microalbuminuria. macroalbuniria and or diminished glomerular filtration rate (GFR - stages 1 and 2); HbA1c from 7.5 to 10%; in regular use of inhibitor Angiotensin Converting Enzyme or Angiotensin Receptor Blocker; Body mass index bellow 40kg / m²; do not make use of pioglitazone; Use of antihyperglycemic medications; Acceptance to participate and to sign informed consent; Patients seen in the outpatient medical clinic of the Faculdade de Medicina of Universidade de Passo Fundo

Exclusion Criteria

Pregnant and lactating women; presence of chronic inflammatory diseases such as arthritis, colitis; Infectious Disease like tuberculosis; use of anti-inflammatory drugs for more than five days in the last three months; previous diagnosis of pancreatitis; hypersensitivity to reigns or its correlates (laxative); Smoking; severe liver disease (transaminases major than 2.5 times the upper limit of normal); severe gastrointestinal disease; participation in another trial in the past 30 days; failure to follow the research protocol requirements

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcomes were reduction ? 15% in ACR, any reduction in GFR, improvement of metabolic control (defined as A1C <7% and fasting glucose <126?mg/dL), reduction in plasma levels of IL-1, IL-6, IL-8, and TNF-?, increase in plasma levels of IL-10, and reduction in blood pressure.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes included reduction in serum levels of fasting insulin, adiponectin, leptin, and selectin.