Comparison of Insulin Alone to Insulin With Metformin to Treat Gestational Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Hgb A1c
研究概览
简要总结
This study is a prospective, unmasked randomized clinical trial comparing the use of insulin vs combination insulin and metformin for treatment in women diagnosed with gestational diabetes mellitus (GDM). The investigator's hypothesis is that the combination of metformin and insulin will be superior to insulin alone to achieve tight glucose control during pregnancy.
详细描述
The objective of this study is to compare the effectiveness of insulin alone vs the combination of insulin and metformin in treating patients with gestational diabetes (GDM). Currently, outside of pregnancy, the treatment of type 2 diabetes mellitus (T2DM) with both metformin and insulin is superior to using insulin alone. In pregnancy, insulin alone has traditionally been used, though some advocate the use of metformin alone as primary therapy. There have been no trials published to date specifically comparing combination therapy to insulin alone. Our hypothesis is that the combination of metformin and insulin will improve overall control of blood glucose, the improvement of which has been demonstrated to improve maternal and neonatal outcomes. Control of blood glucose will be determined by hemoglobin A1c at the time of delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able to read and write English and/or Spanish and give written consent
- •Diagnosis of GDM, defined as an abnormal glucose tolerance test performed after 12 weeks gestation using 1 of the 2 criteria below:
- •50 gram 1 hour oral diabetes screening testing yielding a result of > 200 mg/dL
- •A 100 gram 3 hour oral glucose tolerance testing yielding >2 abnormal values (normal values defined as fasting blood glucose < 95, 1 hour < 180, 2 hour < 155 and 3 hour < 140)
- •Singleton gestation
- •Gestational age between 12 and 34 weeks and 6 days determined by last menstrual period (LMP) confirmed by ultrasound using criteria set forth by the ACOG (Committee on Obstetric Practice). If LMP is unknown then gestational age must be set by ultrasound prior to 20 weeks gestation.
排除标准
- •Pre-existing DM either by diagnosis preceding pregnancy or hemoglobin A1c >6.5 collected during the current pregnancy
- •Uncontrolled chronic hypertension, as this may alter maternal and perinatal outcomes measured.
- •Multiple gestations
- •Major fetal anomalies anticipated to require NICU admission
- •Contraindication to metformin (allergy, history of lactic acidosis, pre-existing renal disease (Cr >1.5 mg/dL), active liver disease, current alcohol abuse).
- •Vitamin B12 deficiency, as metformin reduces intestinal absorption of vitamin B12
- •Medications known to effect glucose metabolism other than insulin and metformin as this may mask any effect between the two treatments.
- •Known inability to tolerate metformin.
研究组 & 干预措施
insulin
干预措施: Insulin (Drug)
insulin and metformin
干预措施: Insulin (Drug)
insulin and metformin
干预措施: Metformin (Drug)
结局指标
主要结局
Hgb A1c
时间窗: collected at the time of delivery
Hgb A1c test
次要结局
- Change in hemoglobin A1c over the course of the pregnancy(hemoglobin A1c will be collected at delivery (per above) and comparison performed after collection)
- Incidence of maternal side effects(Will be assessed weekly until delivery)
- Treatment acceptability(Will be collected postpartum after delivery)
- Incidence of hypertensive disorder of pregnancy(from enrollment through study completion (30 days after delivery))
- Incidence of composite of adverse maternal outcomes(from enrollment through study completion (30 days after delivery))
- Breast feeding status(Will be recorded at the time of hospital discharge after delivery (typically 2-4 days after delivery))
- Mode of delivery(recorded at time of delivery)
- Gestational age at delivery(recorded at time of delivery)
- Infant birthweight (using age/sex matched percentiles)(measured at time of birth)
- Total daily dose of insulin(Will be recorded on hospital admission for delivery)
- Maternal weight gain(This will be calculated as the difference from the weight measured at the inital prenatal visit (the specific timing of which is patient dependant) and at the time of admission for delivery)
- Glucose control(patients will collect glucose values fasting and 2 hrs postprandial every day from enrollment until delivery.)
- Incidence of maternal hypoglycemia(patients will be screened weekly for episodes of hypoglycemia until delivery)
- Incidence of composite neonatal morbidity(from delivery through study completion (30 days after delivery))
- Incidence neonatal hypoglycemia(from delivery through study completion (30 days after delivery))