Diabete Melito
Conditions
Interventions
intervention group- Diacerein 50mg 1 tablet via oral twice a day, for 90 days
other medications should be maintainded.Participant will take 1 capsule at lunch and 1 capsule at dinner for 12 weeks
control group - placebo 1 tablet via oral twice a day, for 90 days, 1 capsule at l
other medications should be maintainded.
All 72 participants (31 intervention group and 31 control group) will be folowed at 7, 30, 60 and 90 days. At the end of follow-up al measures and laboratories
Drug
Sponsors
Hospital de Clinicas de Porto Alegre
Hospital São VIcente de Paulo
Eligibility
Inclusion criteria
Inclusion criteria: 35 years old and older; HbA1c > 7.5%; type 2 Diabete mellitus withou microalbuminuria and/or nephropaty; Using oral antihiperglicemic drugs(sulfonilureias and or metformin)
Exclusion criteria
Exclusion criteria: Pregnant and lactating women; Chronic inflammatory diseases such as rheumatoid arthritis, osteoarthritis; Use of anti-inflammatory drugs for more than 5 days in the last 3 months; Previous diagnosis of pancreatitis; Hypersensitivity to Reina (active metabolite of diacerein) and other antraquinonic derivatives (laxative); Diabetic Nephropathy and \ or kidney failure; Liver disease (transaminases> 2.5 times the upper limit of normality); Severe gastrointestinal disease; Persistent diarrhea (> 3 stools in 24 hours); Signs of intercurrent infection; Participation in another clinical study in past 30 days; Failure to follow the research protocol; using pioglitazone;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The outcome is the delta of plasma concentration of glycated hemoglobin ( final value - baseline value, in %), measured by immunoturbidimetric assay in plasma samples. The between groups expected difference is 1.1%. | — |
Secondary
| Measure | Time frame |
|---|---|
| Delta of fasting glucose (mg/dL); enzymatic and colorimetric method. Levels of acute phase inflammatory markers: C-reactive protein, interleukin-1, interleukin-6, TNF-alpha (Luminex® Human Ultrasensitive ). Delta lipid profile: plasma concentration of total cholesterol, LDL, HDL, triglycerides. Adverse events rate. | — |
Countries
Brazil
Contacts
Public ContactSandra;Sandra Fuchs;Fuchs
Hospital de Clinicas de Porto Alegre;Hospital de Clinicas de Porto Alegre
Outcome results
None listed