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

• Status: Unknown status
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Treatments: Metformin

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.