Metformin as an Adjunctive Therapy For Transient Hyperglycemia in Patients With Acute Lymphoblastic Leukemia During Induction Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Length of Insulin Therapy (Days)
研究概览
简要总结
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
详细描述
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. Patients that develop this complication require treatment with insulin via injections to prevent severe medical complications such as dehydration, weight loss, ketoacidosis and life-threatening infections. Although insulin therapy is effective, it adds a lot of physical and psychological burden to patients because multiple daily insulin injections are required to achieve adequate blood glucose control.
In this pilot study, investigators aim to examine the effectiveness of metformin as an adjunctive treatment for transient hyperglycemia. Investigators will be comparing two groups of subjects (up to 40 subjects per group). Patients in the treatment group will be prospectively recruited, and they will be treated with metformin in addition to insulin therapy. Investigators will compare the treatment group to a historical control group acquired via chart review. These patients will have been treated with insulin alone.
Statistical comparison will be made between the two groups in terms of the length of insulin treatment, the total daily dose of insulin required, number of insulin injections, hemoglobin A1c level (measure of glycemic control over preceding 8- 12 weeks), and fructosamine level (measure of glycemic control over preceding 2-3 weeks).
Investigators hypothesize that the use of metformin will result in fewer numbers of insulin injections and fewer days of insulin therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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%)
研究组 & 干预措施
Metformin and insulin therapy
Up to 30-40 patients will be in the prospectively recruited treatment group, which will receive both metformin and insulin therapy for transient hyperglycemia
干预措施: Metformin (Drug)
结局指标
主要结局
Length of Insulin Therapy (Days)
时间窗: During the 30 days of induction chemotherapy (plus or minus 2 weeks)
次要结局
- Serum Fructosamine Level(At 1 month)
- Hemoglobin A1c(At 1 month)
研究者
Dr. Jamie R. Wood
Assistant Professor of Clinical Pediatrics; Director of Clinical Diabetes Programs at Children's Hospital Los Angeles, University of Southern California, Keck School of Medicine
Children's Hospital Los Angeles