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: * Does diacerein lower levels of inflammatory markers like interleukin-1β, hs-CRP, and TNF-α? * Does diacerein improve blood sugar control? * What side effects or problems do participants have when taking diacerein? 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: * Be adults aged 40-60 with uncontrolled type 2 diabetes * Take either diacerein or a placebo every day for 12 weeks * Visit the clinic for blood tests and monitoring at the beginning and end of the trial * Be evaluated for side effects and medication adherence\]
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
34
The patients received diacerein capsules
Patients received placebo capsules
Universitas Sriwijaya
Palembang, South Sumatera, Indonesia
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: [Time frame: From enrollment to the end of the treatment at 12 weeks]
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: [Time frame: From enrollment to the end of the treatment at 12 weeks]
Secondary Outcome
To analyze the difference in levels of Interleukin-1β before and after the addition of diacerein in patients with uncontrolled diabetes mellitus.
Time frame: [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: [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: [Time frame: From enrollment to the end of the treatment at 12 weeks]
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