Status:
UNKNOWN
Efficacy of Ursodeoxycholic Acid (UDCA) in Patients With Type 2 Diabetes
Lead Sponsor:
University of Banja Luka
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
40-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the effects of ursodeoxycholic acid (UDCA) compared to placebo on biomarkers of oxidative stress, inflammation, and endothelial dysfunction in patients with ty...
Detailed Description
This is a Phase 3, randomized, double-blind, placebo-controlled, evaluation of the efficacy of UDCA on oxidative stress, inflammation, and endothelial dysfunction in combination with metformin after 8...
Eligibility Criteria
Inclusion
- Signed informed consent
- Type 2 Diabetes mellitus verified at least 1 year prior to the study enrollment
- Treatment with metformin at a maximally tolerated dose (up to 2000 mg/day) in patients with an incomplete biochemical response showing HbA1c ≥ 6,5%.
- Body mass index (BMI) corresponding to overweight and obesity (≥ 25 kg/m2)
Exclusion
- Insulin treatment within 12 weeks prior to the study enrollment
- Treatment with Glucagon-like peptide 1 (GLP-1) analogs within 12 weeks prior to the study enrollment
- Systemic administration of glucocorticoids continuously for 10 days within 12 weeks prior to the study enrollment
- Prior and concomitant immunosuppressants treatment (other than glucocorticoids)
- History and current serious psychiatric disorders that could affect treatment adherence
- Co-existing uncontrolled cardiovascular disease (i.e arterial hypertension), respiratory insufficiency, acute or chronic renal failure (creatinine clearance \< 60 ml/min), and liver diseases such as acute or chronic viral hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, non-alcoholic fatty liver disease, hemochromatosis, and liver failure.
- Known history of cholecystitis
- Pregnant or lactating women
- Known hypersensitivity to UDCA, or other bile acids
- History of malignancy diagnosed or treated within 2 years (recent localized treatment of squamous or non-invasive basal skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to Screening)
- Participation in any other interventional study
Key Trial Info
Start Date :
September 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05416580
Start Date
September 12 2022
End Date
April 1 2024
Last Update
May 11 2023
Active Locations (1)
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1
Public Health Institution Dom zdravlja Banja Luka
Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000