Diabetes Mellitus, Type 2 Clinical Trial
— DGCLFT2DMOfficial title:
Efficacy Study of Diacerein on Glycemic Control and Liver Fat in Type 2 Diabetes Subjects
Verified date | May 2018 |
Source | Universidade Federal do Rio de Janeiro |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is conducted to test the hypothesis that in uncontrolled type 2 diabetic adults treatment with diacerein will improve glycemic control and will reduce liver fat within a 24 month period.
Status | Completed |
Enrollment | 84 |
Est. completion date | January 31, 2018 |
Est. primary completion date | January 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Type 2 diabetes. - Presence of liver steatosis diagnosed by ultrasound or transient elastography (Fibroscan®) - Age 30-75 years. - HbA1c 7.5- 9.5 for at least 8 weeks prior to screening. - Stable diabetes therapeutic regimen consisting of either diet, oral hypoglycemic agents with or without insulin for 8 weeks prior to randomization. Exclusion Criteria: - Body mass index > 40 kg/m2 - Serum creatinine =180mmol/L or estimated glomerular filtration rate < 30 ml/min. - Presence of any serious concomitant disease, such as a pulmonary disease or malignant disorders. - Current daily alcohol ingestion =20 g. - Hepatotoxic drugs. - Presence of other chronic liver disease other than nonalcoholic fatty liver disease, including hepatitis B virus and hepatitis C virus infection, hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, autoimmune hepatitis. - Women seeking pregnancy. - Current use or previous use within 6 months of vitamin E or pioglitazone |
Country | Name | City | State |
---|---|---|---|
Brazil | Program of Arterial Hypertension, University Hospital Clementino Fraga Filho | Rio de Janeiro |
Lead Sponsor | Collaborator |
---|---|
Universidade Federal do Rio de Janeiro | Rio de Janeiro State Research Supporting Foundation (FAPERJ) |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evidence of improvement in glycemic control and improvement in liver steatosis | Reduction of mean glycated hemoglobin (= 1%) and reduction of liver fat fraction as measured by transient elastography (= 20%) | Within 12 and 24 months | |
Secondary | Improvement of microalbuminuria | Reduction of albumin excretion rate on 24-hour urine collection | Within 24 months | |
Secondary | Changes of adipocytokines and cytokeratin-18 | Elevation of high molecular weight adiponectin and reduction of the apoptotic by-product cytokeratin (CK)-18 | Within 24 months |
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