Ursodeoxycholic Acid as add-on Therapy in Type 2 Diabetes Mellitus

• Status: Recruiting
• Trial end date: 2024-11-28
• Target enrollment: 0
• Participant gender: All

Summary

Diabetes mellitus (DM) is a complex metabolic disorder characterized by hyperglycemia and abnormalities in carbohydrate, fat, and protein metabolism. It is one of the most prevalent metabolic disorders globally. Despite the advancement in anti-diabetic drug therapy, most patients fail to achieve optimal glycemic control. therefore, there is a large unmet need to develop new strategies to improve the therapeutic outcomes in diabetic patients. This study is designed to evaluate the efficacy of ursodeoxycholic acid as adjunctive therapy in patients with type 2 diabetes mellitus.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tanta University
• Collaborator: Menoufia University
• Treatments: Ursodeoxycholic Acid

Criteria

Inclusion Criteria:

• Patients who have been diagnosed with type 2 diabetes mellitus within the previous 12 months.

• Glycated hemoglobin (HbA1c) between 7% and 9%.

• Body mass index ≥ 25 kg/m2

Exclusion Criteria:

• Pregnant or nursing women.

• Type 1 diabetes mellitus.

• Liver disease (alanine aminotransferase > 3 upper normal limit).

• Kidney disease (estimated glomerular filtration rate < 60 ml/min/1.73 m2).

• Inflammatory bowel diseases

• History of allergy and/or adverse reactions to the drugs used in the study.