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

NCT ID: NCT00791076

Last Updated: 2017-07-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2010-06-30

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Saline Placebo

Saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

2pmol/kg-1/min-1 placebo infused continuously over 72 hours.

Pancreatic Polypeptide

Pancreatic Polypeptide

Group Type: ACTIVE_COMPARATOR

Pancreatic Polypeptide (PP)

Intervention Type: DRUG

2pmol/kg-1/min-1 PP infused continuously over 72 hours.

Interventions

Placebo

2pmol/kg-1/min-1 placebo infused continuously over 72 hours.

Intervention Type: DRUG

Pancreatic Polypeptide (PP)

2pmol/kg-1/min-1 PP infused continuously over 72 hours.

Intervention Type: DRUG

Other Intervention Names

Saline; PP

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dariush Elahi, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00010957

Identifier Type: -

Identifier Source: org_study_id