Uncontrolled Diabetes, Diabetes Mellitus Type 2
Conditions
Keywords
Diacerein, Diabetes Mellitus Type 2, Uncontrolled Diabetes, Interleukin-1β, hs-CRP, TNF-α
Brief summary
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\]
Detailed description
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.
Interventions
The patients received diacerein capsules
DRUGPlacebo
Patients received placebo capsules
Sponsors
Indonesia Endowment Fund for Education (LPDP), Ministry of Finance Republik of Indonesia
Universitas Sriwijaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Patients diagnosed with uncontrolled type 2 diabetes mellitus who are receiving treatment at Dr. Mohammad Hoesin General Hospital, Palembang. 2. Male and female patients aged 40-59 years. 3. Willing to participate in the study by signing the informed consent form.
Exclusion criteria
1. Pregnant or breastfeeding. 2. History of allergy to medications containing rhein. 3. Severe liver disorders. 4. Chronic kidney disease. 5. Malignancy. 6. Currently receiving hormone replacement therapy. 7. Autoimmune diseases. 8. Severe bacterial infection. 9. Osteoarthritis. 10. Use of other anti-inflammatory drugs within the past 2 weeks. Drop-out Criteria 1. Patients who discontinue medication for more than 2 weeks. 2. Death. 3. Occurrence of serious adverse drug reactions requiring discontinuation of the medication. 4. Loss to follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome | [Time frame: From enrollment to the end of the treatment at 12 weeks] | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome | [Time frame: From enrollment to the end of the treatment at 12 weeks] | 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. |
Countries
Indonesia
Outcome results
None listed