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

June 5, 2023 updated by: Eman Ghonaim, Tanta University

A Clinical Study Evaluating the Use od Ursodeoxycholic Acid as Adjuvant Therapy in Type 2 Diabetes Mellitus

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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. More than 75% of diabetic patients live in low- and middle-income countries. About 90% of diabetic patients have type 2 diabetes.

Insulin resistance (IR) and β-cell dysfunction are the two main pathophysiological events contributing to type 2 diabetes.

Insulin resistance is a pathological condition in which insulin-dependent tissues fail to properly respond to normal circulatory levels of insulin. Inflammatory mediators play a key role in insulin resistance. For example, tumor necrosis factor alpha (TNF-α) impairs insulin signaling via serine phosphorylation of insulin receptor substrate (IRS-1). Additionally, it reduces glucose transporter-4 (GLUT-4) expression, limiting glucose entry into adipocytes and skeletal muscle cells. Similarly, IL-6 induces IRS degradation. Oxidative stress interferes with insulin signal transduction leading to IR. It activates several serine-threonine kinase pathways, which, in turn, phosphorylates IRS proteins leading to subsequent degradation.

β-cell dysfunction is associated with β-cell death. In an excessive nutritional state, as in obesity, hyperglycemia and hyperlipidemia are often present, favoring IR and chronic inflammation. Under these circumstances, β-cells are subject to toxic pressures including inflammation, endoplasmic reticulum stress, oxidative stress, as well as amyloid stress, that ultimately lead to loss of islet integrity.

Ursodeoxycholic acid (UDCA) is an endogenous hydrophilic bile acid normally present in human bile and traditionally used for the treatment of liver diseases. UDCA has direct antioxidant properties. It decreased glucose levels, alleviated hyperinsulinemia, and improved islet function in rats with liver fibrosis. Therefore, this study is designed to evaluate the efficacy of ursodeoxycholic acid as adjunctive therapy in patients with type 2 diabetes mellitus.

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • El-Gharbia
      • Tanta, El-Gharbia, Egypt, 31527
        • Recruiting
        • Faculty of medicine, Tanta University
        • Contact:
    • Menoufia
      • Shibīn Al Kawm, Menoufia, Egypt, 32511
        • Recruiting
        • Faculty of Medicine, Menoufia University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group 1
44 diabetic patients receiving dual treatment with metformin and dipeptidyl peptidase-4 (DPP-4) inhibitors (such as vildagliptin)
Active Comparator: Group 2
44 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)
Drug: Ursodeoxycholic acid
ursodeoxycholic acid 500 mg orally twice daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: 12 weeks
Fasting blood glucose, glycated hemoglobin
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipid profile
Time Frame: 12 weeks
Total cholesterol, triglycerides, HDL-cholesterol, and LDL-cholesterol
12 weeks
Insulin resistance
Time Frame: 12 weeks
Fasting insulin, HOMA-IR
12 weeks
Oxidative stress marker
Time Frame: 12 weeks
Serum malondialdehyde
12 weeks
Inflammation marker
Time Frame: 12 weeks
Interleukin-6, high mobility group box-1
12 weeks
Serum asprosin
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Collaborators

Menoufia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 28, 2023

Primary Completion (Estimated)

June 28, 2024

Study Completion (Estimated)

November 28, 2024

Study Registration Dates

First Submitted

June 5, 2023

First Submitted That Met QC Criteria

June 5, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4/2023 INTM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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