Acute Lymphoblastic Leukemia | Metformin and Transient Hyperglycemia
Acute Lymphoblastic Leukemia research study
What is the primary objective of this study?
The purpose of this study is to determine whether metformin is an effective adjunctive treatment for transient hyperglycemia in patients with acute lymphoblastic leukemia (ALL) undergoing induction chemotherapy
Who is eligible to participate?
Inclusion Criteria: - ALL patients on induction chemotherapy who develop transient hyperglycemia(definition of transient hyperglycemia: random blood glucose > 200 mg/dL x 2) - Adequate renal function (serum Cr < 1.5 mg/dL in males, < 1.2 mg/dL in females) - Adequate hepatic function (AST < 5x upper limit of normal) Exclusion Criteria: - Patients with known diagnosis of diabetes or those that are already on oral hypoglycemic agents or insulin - Allergy to metformin or any component of the formulation - Patients with pancreatitis (lipase level > 300 Units/L) - Patients with active infection (positive blood culture within 48 hours of study registration) - Patients with hemodynamic instability (PICU status, need for vasopressors within 48 hours of study entry) - Elevated hemoglobin A1c (greater than 6.0%)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Acute Lymphoblastic Leukemia
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:MetforminAll subjects will be started on metformin 500 mg orally twice daily. The dose will be increased by 500 mg weekly as tolerated until subjects' blood glucoses are well controlled or until the patient reaches metformin 1000 mg PO BID.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Metformin and insulin therapyUp to 30-40 patients will be in the prospectively recruited treatment group, which will receive both metformin and insulin therapy for transient hyperglycemia
Start Date: December 2011
Completed Date: May 2013
Primary Outcome: Length of Insulin Therapy (Days)
Secondary Outcome: Serum Fructosamine Level
Study sponsors, principal investigator, and references
Principal Investigator: Jamie R Wood, M.D.
Lead Sponsor: Children's Hospital Los Angeles
Pui CH, Burghen GA, Bowman WP, Aur RJ. Risk factors for hyperglycemia in children with leukemia receiving L-asparaginase and prednisone. J Pediatr. 1981 Jul;99(1):46-50.