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Efficacy and safety of metformin in the treatment of severe beta thalassemia with impaired glucose regulation: a multicenter, prospective, open, randomized controlled study

Efficacy and safety of metformin in the treatment of severe beta thalassemia with impaired glucose regulation: a multicenter, prospective, open, randomized controlled study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054943
Enrollment
Unknown
Registered
2021-12-29
Start date
2022-04-01
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thalassemia major

Interventions

enhanced iron removal
Group 2:Enhanced iron removal

Sponsors

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Patients with clinical and genetic confirmation of ß-TM and dependent on blood transfusion; 2. Meet IFG and/or IGT criteria according to ADA diagnostic criteria; 3. Age >= 10 and <= 18 years; 4. Male or non-pregnant women, non-breastfeeding women, and women who have no birth plan in the next three years; 5. Not participating in other clinical trials within 3 months; 6. The children and their legal guardians voluntarily participated in the study and signed the informed consent.?

Exclusion criteria

Exclusion criteria: 1. Congestive heart failure and severe pulmonary and renal dysfunction; 2. Impaired liver function, obvious clinical signs or liver disease symptoms, ALT or AST >= 3 x ULN; 3. Stress or other secondary hyperglycemia; 4. Taking drugs that affect glucose metabolism, including hypoglycemic drugs; 5. Active infection.

Design outcomes

Primary

MeasureTime frame
Blood glucose;HbA1C;

Countries

China

Contacts

Public ContactLiang Liyang

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

liangliy@mail.sysu.edu.cn+86 19927412576

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026