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

Phase 2

Terminated

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: Placebo; Drug: Pancreatic Polypeptide (PP)

• Registration Number: NCT00791076
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-11-13
• Study First Submitted QC: 2008-11-13
• Study First Posted: 2008-11-14
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Results First Submitted: 2017-05-01
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-29
• Last Update Submitted: 2017-06-29
• Results First Posted: 2017-07-12
• Last Update Posted: 2017-07-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline Placebo	Placebo	Saline
Pancreatic Polypeptide	Pancreatic Polypeptide (PP)	Pancreatic Polypeptide

Primary Outcome Measures

Name	Time	Method
Total Amount of Insulin Administered While on Placebo/PP.	2 years	Glucose values and the pattern of glycemic excursions over the 72 hour test period.

Secondary Outcome Measures

Name	Time	Method
Frequency of Hypoglycemia Defined as < 60 mg/dl.	72 hours

Trial Locations

Locations (1)

Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States