Status:
TERMINATED
Metformin and Transient Hyperglycemia
Lead Sponsor:
Children's Hospital Los Angeles
Conditions:
Acute Lymphoblastic Leukemia
Hyperglycemia
Eligibility:
All Genders
10-21 years
Phase:
NA
Brief 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 ch...
Detailed Description
ALL is the most common childhood cancer, representing one fourth of all cancers diagnosed under the age of 15 years. One of the most common side effects of ALL chemotherapy is transient hyperglycemia....
Eligibility Criteria
Inclusion
- 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
- 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%)
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01486043
Start Date
December 1 2011
End Date
May 1 2013
Last Update
January 30 2015
Active Locations (1)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027