The Effect of Pancreatic Polypeptide on Insulin Requirements for Type 1 & Post-pancreatectomy Diabetic Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Pancreatic Polypeptide on Insulin Requirements for Type 1 (Auto-immune) and Post-pancreatectomy Diabetic Patients

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: Placebo
* Drug: Pancreatic Polypeptide (PP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Saline Placebo<br>Saline | Drug: Placebo<br>* 2pmol/kg-1/min-1 placebo infused continuously over 72 hours.<br>* Other names: Saline;|
| Active Comparator: Pancreatic Polypeptide<br>Pancreatic Polypeptide | Drug: Pancreatic Polypeptide (PP)<br>* 2pmol/kg-1/min-1 PP infused continuously over 72 hours.<br>* Other names: PP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Amount of Insulin Administered While on Placebo/PP. | Glucose values and the pattern of glycemic excursions over the 72 hour test period. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Hypoglycemia Defined as < 60 mg/dl. |  | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin pump therapy, Type 1 diabetic, Chronic pancreatitis, Pancreatic resection, Pancreatic polypeptide