Diabetes Mellitus, Type 2Phase 2/3NCT05902468
Ursodeoxycholic Acid as add-on Therapy in Type 2 Diabetes Mellitus
A Phase 2/3 study testing Ursodeoxycholic acid in people with Diabetes Mellitus, Type 2, run by Tanta University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Ursodeoxycholic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesEgypt
- Study dates
- 28 Jun 2023to 28 Nov 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Faculty of Medicine, Menoufia University
Shibīn al Kawm, Menoufia, 32511
Eman Ghonaim, Assistant lecturer, +20-010-970-812-57, eman.ghonim@pharm.tanta.edu.eg
- Recruiting
Faculty of medicine, Tanta University
Tanta, El-Gharbia, 31527
Eman Ghonaim, Assistant lecturer, +20-010-970-821-57, eman.ghonim@pharm.tanta.edu.eg
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Ursodeoxycholic acid
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodeoxycholic acidDrug
ursodeoxycholic acid 500 mg orally twice daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | 44 diabetic patients receiving dual treatment with metformin and dipeptidyl peptidase-4 (DPP-4) inhibitors (such as vildagliptin) |
| Group 2 | Active comparator | 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) Receives: Drug: Ursodeoxycholic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
Fasting blood glucose, glycated hemoglobin
Measured: 12 weeks
Secondary outcomes (5)
Lipid profile
Total cholesterol, triglycerides, HDL-cholesterol, and LDL-cholesterol
Measured: 12 weeks
Insulin resistance
Fasting insulin, HOMA-IR
Measured: 12 weeks
Oxidative stress marker
Serum malondialdehyde
Measured: 12 weeks
Inflammation marker
Interleukin-6, high mobility group box-1
Measured: 12 weeks
Serum asprosin
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start28 Jun 2023 (estimated)
- Primary completion28 Jun 2024 (estimated)
- Study completion28 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Collaborators
- Menoufia University
- Responsible party
- Principal investigator, Eman Ghonaim, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902468
- Sponsor's protocol ID
- 4/2023 INTM
- Status last verified
- Jun 2023
- First submitted
- 5 Jun 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Use od Ursodeoxycholic Acid as Adjuvant Therapy in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05902468
- Acronym / sponsor ID
- 4/2023 INTM
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Collaborators
- Menoufia University
- Study start
- 28 Jun 2023 (estimated)
- Primary completion
- 28 Jun 2024 (estimated)
- Study completion
- 28 Nov 2024 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –44 diabetic patients receiving dual treatment with metformin and dipeptidyl peptidase-4 (DPP-4) inhibitors (such as vildagliptin) |
| Group 2 | Active comparator | Drug: Ursodeoxycholic acid44 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ursodeoxycholic acidursodeoxycholic acid 500 mg orally twice daily for 12 weeks | Drug | Group 2 |
Primary outcome
Glycemic control
Time frame: 12 weeks
Fasting blood glucose, glycated hemoglobin
5 secondary outcomes
Lipid profile
Time frame: 12 weeks
Insulin resistance
Time frame: 12 weeks
Oxidative stress marker
Time frame: 12 weeks
Inflammation marker
Time frame: 12 weeks
Serum asprosin
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ursodeoxycholic acid in people with Diabetes Mellitus, Type 2, run by Tanta University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman Ghonaim, Assistant lecturer (+20-010-970-821-57, eman.ghonim@pharm.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.