Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Indonesia Endowment Fund for Education (LPDP), Ministry of Finance Republik of Indonesia | UNKNOWN |
Not provided
Not provided
Not provided
The goal of this clinical trial is to learn if diacerein supplementation can help improve inflammation and glycemic control in adults with uncontrolled type 2 diabetes. It will also study the safety and tolerability of diacerein. The main questions it aims to answer are:
Researchers will compare diacerein to a placebo (a look-alike substance with no active drug) to see if it works better for managing type 2 diabetes.
Participants will:
The study aimed to evaluate the efficacy of diacerein supplementation compared to placebo towards interleukin-1β, hs-CRP, TNF-α levels and glycemic control in uncontrolled type 2 diabetes mellitus patients. The current study was designed as a single-center double-blind randomized controlled clinical trial. The participants were voluntarily recruited 40-60 years old with uncontrolled type 2 diabetes mellitus. Participants were randomized into two groups receiving diacerein add-on therapy or placebo. Evaluations were conducted for side effects and adherence. towards Interleukin-1β, hs-CRP, TNF-α levels and glycemic control were evaluated at the beginning and at the end of the 12 weeks trial for analysis.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diacerein 50 mg capsules | Experimental | The patients were given a capsule containing Diacerein 50 mg twice a day |
|
| Placebo | Placebo Comparator | Patients received placebo capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diacerein 50 mg Capsule | Drug | The patients received diacerein capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome | To determine the effectiveness of adding diacerein compared to placebo towards Interleukin-1β, hs-CRP, TNF-α levels and glycemic control in uncontrolled type 2 diabetes mellitus patients. | [Time frame: From enrollment to the end of the treatment at 12 weeks] |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome | To analyze the difference in levels of HbA1C and fasting plasma glucose (FPG) before and after the addition of diacerein in patients with uncontrolled diabetes mellitus. | [Time frame: From enrollment to the end of the treatment at 12 weeks] |
| Secondary Outcome |
Not provided
Inclusion Criteria:
Exclusion Criteria
Drop-out Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitas Sriwijaya | Palembang | South Sumatera | 30126 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29805981 | Result | Tres GS, Fuchs SC, Piovesan F, Koehler-Santos P, Pereira FDS, Camey S, Lisboa HK, Moreira LB. Effect of Diacerein on Metabolic Control and Inflammatory Markers in Patients with Type 2 Diabetes Using Antidiabetic Agents: A Randomized Controlled Trial. J Diabetes Res. 2018 Apr 2;2018:4246521. doi: 10.1155/2018/4246521. eCollection 2018. | |
| 28818994 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Patients received placebo capsules |
|
To analyze the difference in levels of Interleukin-1β before and after the addition of diacerein in patients with uncontrolled diabetes mellitus. |
| [Time frame: From enrollment to the end of the treatment at 12 weeks] |
| Secondary Outcome | To analyze the difference in levels of hs-CRP before and after the addition of diacerein in patients with uncontrolled diabetes mellitus. | [Time frame: From enrollment to the end of the treatment at 12 weeks] |
| Secondary Outcome | To analyze the factors associated with changes in serum interleukin-1β, hs-CRP, TNF-α and glycemic control before and after the addition of diacerein in patients with uncontrolled type 2 diabetes mellitus. | [Time frame: From enrollment to the end of the treatment at 12 weeks] |
| Cardoso CRL, Leite NC, Carlos FO, Loureiro AA, Viegas BB, Salles GF. Efficacy and Safety of Diacerein in Patients With Inadequately Controlled Type 2 Diabetes: A Randomized Controlled Trial. Diabetes Care. 2017 Oct;40(10):1356-1363. doi: 10.2337/dc17-0374. Epub 2017 Aug 17. |
| 28225996 | Result | Villar MM, Martinez-Abundis E, Preciado-Marquez RO, Gonzalez-Ortiz M. Effect of diacerein as an add-on to metformin in patients with type 2 diabetes mellitus and inadequate glycemic control. Arch Endocrinol Metab. 2017 Mar-Apr;61(2):188-192. doi: 10.1590/2359-3997000000242. Epub 2017 Feb 13. |
| 35246243 | Result | Jangsiripornpakorn J, Srisuk S, Chailurkit L, Nimitphong H, Saetung S, Ongphiphadhanakul B. The glucose-lowering effect of low-dose diacerein and its responsiveness metabolic markers in uncontrolled diabetes. BMC Res Notes. 2022 Mar 4;15(1):91. doi: 10.1186/s13104-022-05974-9. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C025292 | diacerein |
Not provided
Not provided
Not provided