| Trial ID: | L5429 |
| Source ID: | NCT02242149
|
| Associated Drug: |
Diacerein
|
| Title: |
Efficacy Study of Diacerein on Glycemic Control and Liver Fat in Type 2 Diabetes Subjects
|
| Acronym: |
DGCLFT2DM
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|Non-alcoholic Fatty Liver Disease
|
| Interventions: |
DRUG: Diacerein|DRUG: Placebo
|
| Outcome Measures: |
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|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
|
| Sponsor/Collaborators: |
Sponsor: Universidade Federal do Rio de Janeiro | Collaborators: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
84
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-10-14
|
| Completion Date: |
2018-01-31
|
| Results First Posted: |
|
| Last Update Posted: |
2018-05-03
|
| Locations: |
Program of Arterial Hypertension, University Hospital Clementino Fraga Filho, Rio de Janeiro, 21941913, Brazil
|
| URL: |
https://clinicaltrials.gov/show/NCT02242149
|
