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The Potential Hepatoprotective Effect of Metformin in Patients With Beta Thalassemia Major

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ClinicalTrials.gov Identifier: NCT02984475
Recruitment Status : Recruiting
First Posted : December 7, 2016
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Mona Sobhy Abd El-Mon'em Gaber, Cairo University

Brief Summary:

Beta Thalassemia is a major public health problem in Mediterranean countries.In Egypt, it is considered as the most common chronic hemolytic anemia.one of the major complications in this inherited disorder is iron overload which lead to oxidative stress and tissue damage.

Regarding toxic effect of iron overload on liver, hepatomegaly is one of the most findings that resulting from hemosiderosis, extra medullary hematopoiesis, transmitted hepatitis B and C and cirrhosis.

A lot of studies have been carried out recently to study the beneficial role of metformin in non-diabetic patients of different disorders as non-alcoholic fatty liver disease (NAFLD).Among several studies, it's demonstrated that metformin significantly improved insulin resistance, aminotransferase levels and liver morphology.

The role of metformin in these studies is mainly thought to be antioxidant and anti-inflammatory effects. However, the role of Metformin on hepatic function in different populations with the same mechanism of liver injury should be further investigated.

This clinical trial will be carried out on 60 patients with beta thalassemia major receiving regular blood transfusion and iron chelating therapy, either HCV positive or negative patients.

They will be randomly distributed into either control group (group 1, n=30) receiving blood transfusion and taking iron chelating therapy or treatment group (group 2, n=30) receiving blood transfusion and taking iron chelating therapy along with metformin tablets (500 mg/twice daily) for 6 months.


Condition or disease Intervention/treatment Phase
Beta Thalassemia Major Anemia Drug: Metformin Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Potential Hepatoprotective Effect of Metformin in Patients With Beta Thalasemia Major
Study Start Date : December 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : April 2019


Arm Intervention/treatment
Active Comparator: treatment arm
30 patients receiving blood transfusion and taking iron-chelating therapy along with metformin tablets (500 mg once daily for the first week then twice daily for 6 months).
Drug: Metformin
Other Name: Cidophage

No Intervention: control arm
30 patients receiving blood transfusion and taking iron-chelating therapy.



Primary Outcome Measures :
  1. liver enzymes tests. [ Time Frame: 6 months ]
    Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST).


Secondary Outcome Measures :
  1. Metformin Safety - Number of participants with treatment-related adverse events [ Time Frame: 6 months ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  2. liver enzymes and function tests - Alkaline phosphatase (ALP). [ Time Frame: 6 months. ]
    Alkaline phosphatase (ALP).

  3. liver enzymes and function tests - Gama-Glutamyl transferase (GGT). [ Time Frame: 6 months. ]
    Gama-Glutamyl transferase (GGT).

  4. liver enzymes and function tests - total and direct bilirubin. [ Time Frame: 6 months. ]
    total and direct bilirubin.

  5. liver enzymes and function tests - Albumin. [ Time Frame: 6 months. ]
    Albumin .

  6. liver enzymes and function tests - International Normalized Ratio (INR). [ Time Frame: 6 months. ]
    International Normalized Ratio (INR).

  7. oxidative stress markers (MDA). [ Time Frame: 6 months. ]
    Malondialdehyde (MDA)

  8. oxidative stress markers (TAC). [ Time Frame: 6 months. ]
    Total antioxidant capacity (TAC).


Other Outcome Measures:
  1. Fibroscan. [ Time Frame: 6 months ]
    Fibroscan will be done for each patient before and at the end of the study.

  2. FIB 4 score. [ Time Frame: 6 months ]
    Fibrosis 4 score.

  3. APRI score. [ Time Frame: 6 months ]
    AST to platelet ratio index score.



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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with Beta-Thalassemia Major and receiving regular blood transfusion and on iron chelating therapy.
  • Weight: equal to or over 35 kg.
  • Normal renal function.

Exclusion Criteria:

  • Patients with renal impairment (serum creatinine more than twice the upper limit of normal).
  • Patients with heart failure.
  • Patients with sepsis or active infection.
  • Patients with diabetes mellitus (either primary or secondary to thalassemia).
  • regular consumption of medication with potential hepatotoxicity.
  • regular herbal medicine or antioxidant supplementation.
  • patients with gastrointestinal conditions preventing adsorption of oral medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02984475


Locations
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Egypt
Abo El Reesh Hospital Recruiting
Cairo., Egypt
Contact: Mona Gaber, Bachelor.    0223648368    mona.sobhy@pharma.cu.edu.eg   
El Demerdash (Ain Shams Teaching Hospital). Completed
Cairo., Egypt
Sponsors and Collaborators
Cairo University

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Responsible Party: Mona Sobhy Abd El-Mon'em Gaber, Teaching assistant-faculty of pharmacy-Cairo University, Cairo University
ClinicalTrials.gov Identifier: NCT02984475     History of Changes
Other Study ID Numbers: CL 1726
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Mona Sobhy Abd El-Mon'em Gaber, Cairo University:
Beta Thalassemia
Metformin
Oxidative stress
Iron overload
Liver function

Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs