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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Ursodeoxycholic acid
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of medicine, Tanta UniversityRecruiting
  • Faculty of Medicine, Menoufia UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

44 diabetic patients receiving dual treatment with metformin and dipeptidyl peptidase-4 (DPP-4) inhibitors (such as vildagliptin)

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)

Outcomes

Primary Outcome Measures

Glycemic control
Fasting blood glucose, glycated hemoglobin

Secondary Outcome Measures

Lipid profile
Total cholesterol, triglycerides, HDL-cholesterol, and LDL-cholesterol
Insulin resistance
Fasting insulin, HOMA-IR
Oxidative stress marker
Serum malondialdehyde
Inflammation marker
Interleukin-6, high mobility group box-1
Serum asprosin

Full Information

First Posted
June 5, 2023
Last Updated
June 5, 2023
Sponsor
Tanta University
Collaborators
Menoufia University
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1. Study Identification

Unique Protocol Identification Number
NCT05902468
Brief Title
Ursodeoxycholic Acid as add-on Therapy in Type 2 Diabetes Mellitus
Official Title
A Clinical Study Evaluating the Use od Ursodeoxycholic Acid as Adjuvant Therapy in Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2023 (Anticipated)
Primary Completion Date
June 28, 2024 (Anticipated)
Study Completion Date
November 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
Collaborators
Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
No Intervention
Arm Description
44 diabetic patients receiving dual treatment with metformin and dipeptidyl peptidase-4 (DPP-4) inhibitors (such as vildagliptin)
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic acid
Intervention Description
ursodeoxycholic acid 500 mg orally twice daily for 12 weeks
Primary Outcome Measure Information:
Title
Glycemic control
Description
Fasting blood glucose, glycated hemoglobin
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Lipid profile
Description
Total cholesterol, triglycerides, HDL-cholesterol, and LDL-cholesterol
Time Frame
12 weeks
Title
Insulin resistance
Description
Fasting insulin, HOMA-IR
Time Frame
12 weeks
Title
Oxidative stress marker
Description
Serum malondialdehyde
Time Frame
12 weeks
Title
Inflammation marker
Description
Interleukin-6, high mobility group box-1
Time Frame
12 weeks
Title
Serum asprosin
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eman Ghonaim, Assistant lecturer
Phone
+20-010-970-821-57
Email
eman.ghonim@pharm.tanta.edu.eg
Facility Information:
Facility Name
Faculty of medicine, Tanta University
City
Tanta
State/Province
El-Gharbia
ZIP/Postal Code
31527
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eman Ghonaim, Assistant lecturer
Phone
+20-010-970-821-57
Email
eman.ghonim@pharm.tanta.edu.eg
Facility Name
Faculty of Medicine, Menoufia University
City
Shibīn Al Kawm
State/Province
Menoufia
ZIP/Postal Code
32511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eman Ghonaim, Assistant lecturer
Phone
+20-010-970-812-57
Email
eman.ghonim@pharm.tanta.edu.eg

12. IPD Sharing Statement

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

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