The Effect of Pancreatic Polypeptide on Insulin Requirements for Type 1 (Auto-immune) and Post-pancreatectomy Diabetic Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Total Amount of Insulin Administered While on Placebo/PP.
研究概览
简要总结
The goal of this research is to see if pancreatic polypeptide (PP), a hormone that is naturally produced by the pancreas and that works to control the amount of glucose that the liver makes, will reduce the amount of insulin required for people who must take insulin to maintain their normal blood glucose level.
详细描述
The pancreas is a large gland located behind the stomach. One of the functions of the pancreas is to produce two hormones: insulin and pancreatic polypeptide. Insulin helps the cells to take in glucose. The liver makes glucose and insulin normally acts to decrease or shut off the liver's production of glucose. However, in patients whose pancreas no longer makes insulin or makes low levels of pancreatic polypeptide the liver cannot perform these duties as well. Studies have shown that these important functions of the liver are improved for these patients when pancreatic polypeptide is given together with their insulin. Because PP increases the liver's sensitivity to insulin and thereby reduces the amount of glucose produced by the liver, this will result in fewer swings in blood sugar levels both in the upper and lower range. With fewer swings in blood glucose, a patient should decrease the amount of insulin used. One of the main benefits of lowering total insulin requirement is a reduction in the development of dangerous low blood sugar levels.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female volunteers between the ages of 18-75 with:
- •10 subjects who are status post pancreatic resection and 10 volunteers who are Type 1 diabetic for > 8 years (volunteers must have a stable glycemic profile that includes use of an insulin pump to control their blood glucose) with or without prior pancreatic resection.
- •HbA1c levels ≤ 8.5.
排除标准
- •Lactating or pregnant females.
- •Brittle or Labile diabetics: Volunteers with extremely erratic patterns of glucose control with large fluctuations in glucose levels for no obvious reason.
- •Allergy to beef or beef by-products.
- •Hypoglycemia within the past year requiring medical or other assistance to correct.
- •Known autonomic neuropathy.
- •Documented blood glucose under 60 mg within the past year and hypoglycemic unawareness.
- •Durations of type 1 Diabetes Melitis (DM) ≤ 8 years.
- •Not currently on pump therapy.
- •Type 1 DM who has a BMI ≥ 35.
研究组 & 干预措施
Saline Placebo
Saline
干预措施: Placebo (Drug)
Pancreatic Polypeptide
Pancreatic Polypeptide
干预措施: Pancreatic Polypeptide (PP) (Drug)
结局指标
主要结局
Total Amount of Insulin Administered While on Placebo/PP.
时间窗: 2 years
Glucose values and the pattern of glycemic excursions over the 72 hour test period.
次要结局
- Frequency of Hypoglycemia Defined as < 60 mg/dl.(72 hours)