Using Ursodeoxycholic Acid to Help Manage Type 2 Diabetes
A Clinical Study Evaluating the Use od Ursodeoxycholic Acid as Adjuvant Therapy in Type 2 Diabetes Mellitus
This study is testing if adding ursodeoxycholic acid can help people with type 2 diabetes better control their blood sugar levels.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 2 sites (Tanta, El-Gharbia and 1 other locations) |
| Trial ID | NCT05902468 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of ursodeoxycholic acid as an additional treatment for patients with type 2 diabetes mellitus. It aims to address the significant unmet need for improved glycemic control in diabetic patients, particularly those diagnosed within the last year. The study focuses on patients with specific criteria, including a glycated hemoglobin level between 7% and 9% and a body mass index of 25 or higher. By investigating the role of this medication, the study hopes to enhance therapeutic outcomes for individuals struggling with diabetes management.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with type 2 diabetes within the past year, with specific HbA1c and BMI criteria.
Not a fit: Patients with type 1 diabetes, liver or kidney disease, or those who are pregnant or nursing may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to better blood sugar control for patients with type 2 diabetes.
How similar studies have performed: While the use of ursodeoxycholic acid in diabetes management is not widely tested, similar approaches targeting insulin resistance have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tanta, El-Gharbia and 1 other locations
- Faculty of medicine, Tanta University — Tanta, El-Gharbia, Egypt (Recruiting)
- Faculty of Medicine, Menoufia University — Shibīn Al Kawm, Menoufia, Egypt (Recruiting)
Study contacts
- Study coordinator: Eman Ghonaim, Assistant lecturer
- Email: eman.ghonim@pharm.tanta.edu.eg
- Phone: +20-010-970-821-57
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.