Metformin and Transient Hyperglycemia

Stopped early · Not applicable

Conditions studied: Acute Lymphoblastic Leukemia, Hyperglycemia, Insulin Resistance, Diabetes Mellitus

In brief

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

Key facts

Study ID

NCT01486043

Run by

Children's Hospital Los Angeles

People needed

4

Starts

2011-12-01

Expected to finish

2013-05-01

Last updated by the study team

2015-01-30

Who can join

Age: 10 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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%)

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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