Effect of Continuing Versus Holding Metformin During Hospitalizations to Internal Medicine on Glucose Control, Acidosis, Abdominal Symptoms, Length of Stay, and Mortality.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Mean glucose levels
研究概览
简要总结
A randomized study of continuing versus holding metformin during hospitalizations to internal medicine services to determine the effects on glucose control, acidosis, abdominal symptoms, length of stay, and mortality.
详细描述
The purpose of this study is to determine what the effects of the routine practice of holding metformin in hospitalized patients with type 2 diabetes are on outcomes.
The objectives of this study are to determine how holding versus continuing metformin during hospitalization to an internal medicine service affects the incidences of lactic acidosis, mean anion gap, mean glucose levels, low and very high blood sugars, GI effects after discharge, lack of continuation of metformin upon discharge, mean glucose levels, lengths of stay, and 30-day mortality.
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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (18+ years of age)
- •Admitted to an internal medicine service.
- •On Metformin prior to admission.
排除标准
- •Inability to take oral medications
- •eGFR < 30 ml/min/1.73 m2
- •Current Acidosis (pH < 7.35) including diabetic ketoacidosis
- •Child-Turcotte-Pugh class C hepatic cirrhosis
- •Acute Decompensated Heart Failure
- •Cognitively impaired and/or unable to consent
- •Lack of or unwillingness to share contact information
- •Pregnant women
研究组 & 干预措施
Metformin continuation
Continuation of home metformin regimen during hospitalization to an internal medicine service
干预措施: Metformin (Drug)
结局指标
主要结局
Mean glucose levels
时间窗: During hospitalization
Average of daily glucose levels during hospitalization
次要结局
- Incidence of hyperglycemia greater than 300 mg/dl.(During hospitalization)
- Incidence of hypoglycemia (Glu = 54 - 70).(During hospitalization)
- Incidence of moderate hypoglycemia (Glu < 54)(During hospitalization)
- Incidence of severe hypoglycemia (Glu < 54 with symptoms)(During hospitalization)
- Mean lactic acid levels.(During hospitalization)
- Incidence of lactic acid levels greater than 2.0.(During hospitalization)
- Mean anion gap.(During hospitalization)
- Incidence of anion gap > 11(During hospitalization)
- Incidence of elevated lactic acid level or anion gap.(During hospitalization)
- Incidence of inadvertently not continuing metformin on discharge(At discharge)
- GI adverse effects(Within 3 days of discharge)
- Mortality(30 +/- 3 days after discharge)