To study and know the efficiency of the anti- diabetic drug Metformin in patients who develop high blood sugar levels during the treatment phase of acute leukemia or blood cancer since they receive high dose steroids which causes high blood sugar levels.
Phase 4
- Conditions
- Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
- Registration Number
- CTRI/2023/12/060401
- Lead Sponsor
- I
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Treatment-naïve, newly diagnosed adults (= 18 years of age) with ALL requiring Insulin therapy for hyperglycemia during first 14 days of Induction chemotherapy, coming to the Department of Hematology after the Ethical approval for the study is granted, and providing informed consent for inclusion in the study, will be included in the study.
Exclusion Criteria
Known case or newly diagnosed Diabetic individuals or Already on Metformin therapy or with Contra-Indications to Metformin therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study the efficacy of Metformin as the anti-hyperglycemic agent during the Induction therapy in ALL patients by assessing the change/reduction in daily Insulin requirement.Timepoint: End of Induction therapy
- Secondary Outcome Measures
Name Time Method To know the effect of metformin on End of Induction Measurable residual disease by comparing it with Measurable residual disease of Patients who didn’t receive Metformin.Timepoint: End of Induction therapy