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

Effect of diacerein on renal function, metabolic control and acute inflamatory parameters in type 2 diabetic patients with nephropaty - randomized clinical trial - : Diacereina trial on diabetes mellitus with nephropaty

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-2tfwq3
Enrollment
Unknown
Registered
2016-11-07
Start date
2014-03-07
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mellitus Diabetes Diabetic nephropathy Kidney Failure, Chronic

Interventions

There are two groups: Experimental group 1: 35 patients with diabetes and chronic kidney disease will receive 01 capsule of diacerein 50 mg , oral, twice a day during 90 days. Control group: 35 pati
Drug

Sponsors

Universidade Federal do Rio Grande do Sul
Lead Sponsor
Hospital São VIcente de Paulo
Collaborator
Hospital de Clinicas de Porto Alegre
Collaborator

Eligibility

Age
30 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary outcomes included reduction in serum levels of fasting insulin, adiponectin, leptin, and selectin.

Countries

Brazil

Contacts

Public ContactSandra Fuchs

Universidade Federal do Rio Grande do Sul

scfuchs@terra.com.br+555133597621

Outcome results

None listed

Source: REBEC (via WHO ICTRP)