Prevention of Stress Hyperglycemia With the Use of DPP-4 Inhibitors in Non-diabetic Patients Undergoing Non-cardiac Surgery, a Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of Participants Experiencing Stress Hyperglycemia
研究概览
简要总结
The purpose of this study is to compare sitagliptin with a placebo for the prevention of high glucose after general surgery.
详细描述
Approximately 30-40% of hospitalized patients will develop stress hyperglycemia (high glucose in response to surgery or illness). High glucose is linked to an increased risk of hospital complications including wound infection, kidney failure and death. Patients with high glucose are treated with insulin given through an arm vein or by frequent insulin injections under the skin. Recent studies have found that inpatient therapy with oral dipeptidyl peptidase-4 inhibitor (DPP4-I) is an effective alternative to insulin in improving glycemic control with low risk of hypoglycemia in general medicine and surgical patients.
Sitagliptin is an oral medication approved by the Food and Drug Administration (FDA) to treat patients with diabetes. The aim of this study is to determine whether treatment with sitagliptin once daily can prevent the development of stress hyperglycemia during the postoperative period in non-diabetic patients undergoing general surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing non-cardiac surgery
- •No previous history of diabetes or hyperglycemia
- •Fasting blood glucose level of <126 mg/dl
- •Blood glucose <126mg/dl at the time of randomization (could occur at any time of the day)
排除标准
- •History of hyperglycemia (blood glucose equal to or above 126 mg/dl or HbA1C greater than 6.5%) or previous treatment with oral antidiabetic agents or insulin
- •Patients undergoing cardiac surgery
- •Patients anticipated to require ICU care following surgery
- •Severely impaired renal function (GFR < 30 ml/min) or clinically significant hepatic failure
- •Moribund patients and those at imminent risk of death (brain death or cardiac standstill)
- •Patients with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction
- •Patients with clinically relevant pancreatic or gallbladder disease
- •Treatment with oral (> 5 mg/day) or injectable corticosteroid
- •Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
- •Pregnancy or breast-feeding at time of enrollment
研究组 & 干预措施
Sitagliptin Arm
Participants will receive sitagliptin beginning the day prior to surgery and continuing daily during hospitalization (up to 10 days post-surgery).
Point of care (POC) testing will be done four times daily, before meals and at bedtime, or every 6 hours for patients who are not eating (NPO). Patients developing hyperglycemia during or after surgery will be treated with insulin per standard of care.
Patients with fasting and/or premeal blood glucose levels >180 mg/dl will receive supplemental insulin provided on a sliding scale. Patients with two consecutive fasting and/or premeal blood glucose levels >180 mg/dl, or with average daily blood glucose levels >180 mg/dl will be started on rescue therapy with subcutaneous insulin once daily plus correction doses by a sliding scale.
干预措施: Sitagliptin (Drug)
Sitagliptin Arm
Participants will receive sitagliptin beginning the day prior to surgery and continuing daily during hospitalization (up to 10 days post-surgery).
Point of care (POC) testing will be done four times daily, before meals and at bedtime, or every 6 hours for patients who are not eating (NPO). Patients developing hyperglycemia during or after surgery will be treated with insulin per standard of care.
Patients with fasting and/or premeal blood glucose levels >180 mg/dl will receive supplemental insulin provided on a sliding scale. Patients with two consecutive fasting and/or premeal blood glucose levels >180 mg/dl, or with average daily blood glucose levels >180 mg/dl will be started on rescue therapy with subcutaneous insulin once daily plus correction doses by a sliding scale.
干预措施: Supplemental insulin (insulin lispro) (Drug)
Sitagliptin Arm
Participants will receive sitagliptin beginning the day prior to surgery and continuing daily during hospitalization (up to 10 days post-surgery).
Point of care (POC) testing will be done four times daily, before meals and at bedtime, or every 6 hours for patients who are not eating (NPO). Patients developing hyperglycemia during or after surgery will be treated with insulin per standard of care.
Patients with fasting and/or premeal blood glucose levels >180 mg/dl will receive supplemental insulin provided on a sliding scale. Patients with two consecutive fasting and/or premeal blood glucose levels >180 mg/dl, or with average daily blood glucose levels >180 mg/dl will be started on rescue therapy with subcutaneous insulin once daily plus correction doses by a sliding scale.
干预措施: Supplemental insulin (insulin aspart) (Drug)
Sitagliptin Arm
Participants will receive sitagliptin beginning the day prior to surgery and continuing daily during hospitalization (up to 10 days post-surgery).
Point of care (POC) testing will be done four times daily, before meals and at bedtime, or every 6 hours for patients who are not eating (NPO). Patients developing hyperglycemia during or after surgery will be treated with insulin per standard of care.
Patients with fasting and/or premeal blood glucose levels >180 mg/dl will receive supplemental insulin provided on a sliding scale. Patients with two consecutive fasting and/or premeal blood glucose levels >180 mg/dl, or with average daily blood glucose levels >180 mg/dl will be started on rescue therapy with subcutaneous insulin once daily plus correction doses by a sliding scale.
干预措施: Long acting basal insulin (insulin detemir) (Drug)
Sitagliptin Arm
Participants will receive sitagliptin beginning the day prior to surgery and continuing daily during hospitalization (up to 10 days post-surgery).
Point of care (POC) testing will be done four times daily, before meals and at bedtime, or every 6 hours for patients who are not eating (NPO). Patients developing hyperglycemia during or after surgery will be treated with insulin per standard of care.
Patients with fasting and/or premeal blood glucose levels >180 mg/dl will receive supplemental insulin provided on a sliding scale. Patients with two consecutive fasting and/or premeal blood glucose levels >180 mg/dl, or with average daily blood glucose levels >180 mg/dl will be started on rescue therapy with subcutaneous insulin once daily plus correction doses by a sliding scale.
干预措施: Long acting basal insulin (insulin glargine) (Drug)
Placebo Arm
Participants will receive a placebo tablet beginning the day prior to surgery and continuing daily during hospitalization (up to 10 days post-surgery).
Point of care (POC) testing will be done four times daily, before meals and at bedtime, or every 6 hours for patients who are not eating (NPO). Patients developing hyperglycemia during or after surgery will be treated with insulin per standard of care.
Patients with fasting and/or premeal blood glucose levels >180 mg/dl will receive supplemental insulin provided on a sliding scale. Patients with two consecutive fasting and/or premeal blood glucose levels >180 mg/dl, or with average daily blood glucose levels >180 mg/dl will be started on rescue therapy with subcutaneous insulin once daily plus correction doses by a sliding scale.
干预措施: Placebo (Drug)
Placebo Arm
Participants will receive a placebo tablet beginning the day prior to surgery and continuing daily during hospitalization (up to 10 days post-surgery).
Point of care (POC) testing will be done four times daily, before meals and at bedtime, or every 6 hours for patients who are not eating (NPO). Patients developing hyperglycemia during or after surgery will be treated with insulin per standard of care.
Patients with fasting and/or premeal blood glucose levels >180 mg/dl will receive supplemental insulin provided on a sliding scale. Patients with two consecutive fasting and/or premeal blood glucose levels >180 mg/dl, or with average daily blood glucose levels >180 mg/dl will be started on rescue therapy with subcutaneous insulin once daily plus correction doses by a sliding scale.
干预措施: Supplemental insulin (insulin lispro) (Drug)
Placebo Arm
Participants will receive a placebo tablet beginning the day prior to surgery and continuing daily during hospitalization (up to 10 days post-surgery).
Point of care (POC) testing will be done four times daily, before meals and at bedtime, or every 6 hours for patients who are not eating (NPO). Patients developing hyperglycemia during or after surgery will be treated with insulin per standard of care.
Patients with fasting and/or premeal blood glucose levels >180 mg/dl will receive supplemental insulin provided on a sliding scale. Patients with two consecutive fasting and/or premeal blood glucose levels >180 mg/dl, or with average daily blood glucose levels >180 mg/dl will be started on rescue therapy with subcutaneous insulin once daily plus correction doses by a sliding scale.
干预措施: Supplemental insulin (insulin aspart) (Drug)
Placebo Arm
Participants will receive a placebo tablet beginning the day prior to surgery and continuing daily during hospitalization (up to 10 days post-surgery).
Point of care (POC) testing will be done four times daily, before meals and at bedtime, or every 6 hours for patients who are not eating (NPO). Patients developing hyperglycemia during or after surgery will be treated with insulin per standard of care.
Patients with fasting and/or premeal blood glucose levels >180 mg/dl will receive supplemental insulin provided on a sliding scale. Patients with two consecutive fasting and/or premeal blood glucose levels >180 mg/dl, or with average daily blood glucose levels >180 mg/dl will be started on rescue therapy with subcutaneous insulin once daily plus correction doses by a sliding scale.
干预措施: Long acting basal insulin (insulin detemir) (Drug)
Placebo Arm
Participants will receive a placebo tablet beginning the day prior to surgery and continuing daily during hospitalization (up to 10 days post-surgery).
Point of care (POC) testing will be done four times daily, before meals and at bedtime, or every 6 hours for patients who are not eating (NPO). Patients developing hyperglycemia during or after surgery will be treated with insulin per standard of care.
Patients with fasting and/or premeal blood glucose levels >180 mg/dl will receive supplemental insulin provided on a sliding scale. Patients with two consecutive fasting and/or premeal blood glucose levels >180 mg/dl, or with average daily blood glucose levels >180 mg/dl will be started on rescue therapy with subcutaneous insulin once daily plus correction doses by a sliding scale.
干预措施: Long acting basal insulin (insulin glargine) (Drug)
结局指标
主要结局
Number of Participants Experiencing Stress Hyperglycemia
时间窗: Up to time of discharge from hospital, an average of 10 days
The number of participants with at least one episode of stress hyperglycemia. Stress hyperglycemia is defined as a blood glucose \> 180 mg/dL.
次要结局
- Number of Patients Requiring Supplemental, Subcutaneous Insulin(Up to time of discharge from hospital, an average of 10 days)
- Total Daily Dose of Insulin for Patients Requiring Supplemental Insulin(Up to time of discharge from hospital, an average of 10 days)
- Length of Hospital Stay(Up to time of discharge from hospital, an average of 10 days)
- Number of Participants With Hypoglycemic Events(Up to time of discharge from hospital, an average of 10 days)
- Number of Patients Transferred to the ICU Immediately After Surgery or During Hospitalization(Up to time of discharge from hospital, an average of 10 days)
- Number of Days in the ICU(Up to time of discharge from hospital, an average of 10 days)
- Number of Participants With Hospital Readmissions After Discharge(Up to 40 days (average time of discharge from the hospital plus 30 days))
- Number of Participants With Emergency Room Visits After Discharge(Up to 40 days (average time of discharge from the hospital plus 30 days))
- Number of Participants Experiencing Complications(Up to 40 days (average time of discharge from the hospital plus 30 days))
研究者
Maya Fayfman
Instructor of Medicine
Emory University