Ursodeoxycholic Acid as add-on Therapy in Type 2 Diabetes Mellitus
A Clinical Study Evaluating the Use od Ursodeoxycholic Acid as Adjuvant Therapy in Type 2 Diabetes Mellitus
1 other identifier
interventional
88
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 diabetes-mellitus-type-2
Started Jun 2023
Typical duration for phase_2 diabetes-mellitus-type-2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedStudy Start
First participant enrolled
June 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 28, 2024
CompletedJune 15, 2023
June 1, 2023
1 year
June 5, 2023
June 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Glycemic control
Fasting blood glucose, glycated hemoglobin
12 weeks
Secondary Outcomes (5)
Lipid profile
12 weeks
Insulin resistance
12 weeks
Oxidative stress marker
12 weeks
Inflammation marker
12 weeks
Serum asprosin
12 weeks
Study Arms (2)
Group 1
NO INTERVENTION44 diabetic patients receiving dual treatment with metformin and dipeptidyl peptidase-4 (DPP-4) inhibitors (such as vildagliptin)
Group 2
ACTIVE COMPARATOR44 diabetic patients who will receive ursodeoxycholic acid 500 mg orally twice daily in addition to dual treatment with metformin and dipeptidyl peptidase-4 (DPP-4) inhibitors (such as vildagliptin)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
- Menoufia Universitycollaborator
Study Sites (2)
Faculty of medicine, Tanta University
Tanta, El-Gharbia, 31527, Egypt
Faculty of Medicine, Menoufia University
Shibīn al Kawm, Menoufia, 32511, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Eman Mabrouk Mahmoud Ghonaim
Study Record Dates
First Submitted
June 5, 2023
First Posted
June 15, 2023
Study Start
June 28, 2023
Primary Completion
June 28, 2024
Study Completion
November 28, 2024
Last Updated
June 15, 2023
Record last verified: 2023-06