Metformin and Transient Hyperglycemia

• Status: Terminated
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Los Angeles
• Treatments: Insulin; Insulin, Globin Zinc; Metformin

Criteria

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%)