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

NCT02984475 | Unknown Phase 4

• 1 other identifier: CL 1726
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Beta Thalassemia Major Anemia

Keywords

Beta Thalassemia; Metformin; Oxidative stress; Iron overload; Liver function

Outcome Measures

Primary Outcomes (1)

• liver enzymes tests.

  Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST).

  6 months

Secondary Outcomes (8)

• Metformin Safety - Number of participants with treatment-related adverse events

  6 months

• liver enzymes and function tests - Alkaline phosphatase (ALP).

  6 months.

• liver enzymes and function tests - Gama-Glutamyl transferase (GGT).

  6 months.

• liver enzymes and function tests - total and direct bilirubin.

  6 months.

• liver enzymes and function tests - Albumin.

  6 months.

Other Outcomes (3)

• Fibroscan.

  6 months

• FIB 4 score.

  6 months

• APRI score.

  6 months

Study Arms (2)

treatment arm

ACTIVE COMPARATOR

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

control arm

NO INTERVENTION

30 patients receiving blood transfusion and taking iron-chelating therapy.

Interventions

Metformin DRUG

Also known as: Cidophage

treatment arm

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Abo El Reesh Hospital

Cairo, Egypt

RECRUITING

El Demerdash (Ain Shams Teaching Hospital).

Cairo, Egypt

COMPLETED

MeSH Terms

Conditions

beta-Thalassemia; Iron Overload

Interventions

Metformin

Condition Hierarchy (Ancestors)

Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant-faculty of pharmacy-Cairo University

Study Record Dates

• First Submitted: November 25, 2016
• First Posted: December 7, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: April 1, 2019
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

EG (2)