Clinical trial NCT00791076: The Effect of Pancreatic Polypeptide on Insulin Requirements for Type 1 & Post-pancreatectomy Diabetic Patients
Official title: The Effect of Pancreatic Polypeptide on Insulin Requirements for Type 1 (Auto-immune) and Post-pancreatectomy Diabetic Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 1
Keywords: Insulin pump therapy
Type 1 diabetic
Chronic pancreatitis
Pancreatic resection
Pancreatic polypeptide
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2008-11-14
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total Amount of Insulin Administered While on Placebo/PP.
timeFrame: 2 years
Secondary outcomes:
measure: Frequency of Hypoglycemia Defined as < 60 mg/dl.
timeFrame: 72 hours
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Dariush Elahi, PhD
role: PRINCIPAL_INVESTIGATOR
References: