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

June 29, 2017 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Saline Placebo
Saline
Drug: Placebo
2pmol/kg-1/min-1 placebo infused continuously over 72 hours.
Other Names:
  • Saline
ACTIVE_COMPARATOR: Pancreatic Polypeptide
Drug: Pancreatic Polypeptide (PP)
2pmol/kg-1/min-1 PP infused continuously over 72 hours.
Other Names:
  • PP

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2007

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

November 13, 2008

First Submitted That Met QC Criteria

November 13, 2008

First Posted (ESTIMATE)

November 14, 2008

Study Record Updates

Last Update Posted (ACTUAL)

July 12, 2017

Last Update Submitted That Met QC Criteria

June 29, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00010957

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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