Efficacy Study of Diacerein on Glycemic Control and Liver Fat in Type 2 Diabetes Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Evidence of improvement in glycemic control and improvement in liver steatosis
研究概览
简要总结
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.
详细描述
Background: Recently, knowledge about diacerhein, an anthraquinone drug with powerful anti-inflammatory properties, revealed that this drug improves insulin sensitivity, mediated by the reversal of chronic subclinical inflammation. Amongst the numerous pathogenetic factors, oxidative stress and apoptosis of hepatocytes initiate many inflammatory processes and are involved in the progression of Non alcoholic fatty liver disease.
Aims:The aim is to evaluate the effect of treatment with diacerein in improvement of glycemic parameters (mean glycated hemoglobin, fasting blood sugar) and reduction of liver fat fraction.
Methods:Two-hundred patients will be randomly allocated either to treatment with diacerein plus their usual therapeutic regimen or to placebo for 24 months. Clinic, laboratory evaluation (including glycated hemoglobin, fasting blood sugar, creatinine, ferritin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), g-glutamyl transpeptidase, alkaline phosphatase, bilirubin, albumin, prothrombin time, platelet count, total cholesterol, high-density and low-density lipoprotein cholesterol and triglycerides and urinary albumin excretion rate no 24-hour urine collection) will be performed before and every 3 months until the end of study. Pro-Inflammatory cytokines, adiponectin and cytokeratin-18 were measured before, at 12 months and at the end of study. Liver fat fraction measurement using controlled attenuation parameter (CAP) by transient elastography. (Fibroscan) will be performed before and after the 12 and 24-month treatment, with the observers blinded to the allocation group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Placebo
All subjects will be given placebo identically matched with regard to shape, color and taste. They will be given one tablet/day for 2 weeks and then two tablets/day for the duration of sudy.
干预措施: Placebo (Drug)
Diacerein
All subjects will be given diacerein with a starting dose of 50 mg in one tablet once daily for 2 weeks. After 2 weeks, they will be given diacerein 50 mg in one tablet twice daily for the duration of sudy.
干预措施: Diacerein (Drug)
结局指标
主要结局
Evidence of improvement in glycemic control and improvement in liver steatosis
时间窗: Within 12 and 24 months
Reduction of mean glycated hemoglobin (≥ 1%) and reduction of liver fat fraction as measured by transient elastography (≥ 20%)
次要结局
- Improvement of microalbuminuria(Within 24 months)
- Changes of adipocytokines and cytokeratin-18(Within 24 months)
研究者
Gil Fernando da Costa Mendes de Salles, PhD
Full Professor, Faculty of Medicine
Universidade Federal do Rio de Janeiro