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

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ClinicalTrials.gov Identifier: NCT00791076
Recruitment Status : Terminated (PI left JHU)
First Posted : November 14, 2008
Results First Posted : July 12, 2017
Last Update Posted : July 12, 2017
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Placebo Drug: Pancreatic Polypeptide (PP) Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Pancreatic Polypeptide on Insulin Requirements for Type 1 (Auto-immune) and Post-pancreatectomy Diabetic Patients
Actual Study Start Date : October 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Saline Placebo
Saline
 Drug: Placebo
2pmol/kg-1/min-1 placebo infused continuously over 72 hours.
Other Name: Saline
Active Comparator: Pancreatic Polypeptide
Pancreatic Polypeptide
 Drug: Pancreatic Polypeptide (PP)
2pmol/kg-1/min-1 PP infused continuously over 72 hours.
Other Name: PP


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Frequency of Hypoglycemia Defined as < 60 mg/dl. [ Time Frame: 72 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791076


Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Dariush Elahi, PhD Johns Hopkins University
More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00791076     History of Changes
Other Study ID Numbers: NA_00010957
First Posted: November 14, 2008    Key Record Dates
Results First Posted: July 12, 2017
Last Update Posted: July 12, 2017
Last Verified: June 2017

Keywords provided by Johns Hopkins University:
Insulin pump therapy
Type 1 diabetic
Chronic pancreatitis
Pancreatic resection
Pancreatic polypeptide

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin
Pancreatic Polypeptide
Hypoglycemic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists