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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Johns Hopkins University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00791076
First received: November 13, 2008
Last updated: March 25, 2010
Last verified: March 2010
History of Changes
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 1
 Drug: Placebo
Drug: Pancreatic Polypeptide (PP)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effect of Pancreatic Polypeptide on Insulin Requirements for Type 1 (Auto-immune) and Post-pancreatectomy Diabetic Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Total amount of insulin administered while on placebo/PP. Glucose values and the pattern of glycemic excursions over the 72 hour test period. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of hypoglycemia defined as < 60 mg/dl. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2007
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Saline
 Drug: Placebo
2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours.
Other Name: Saline
Active Comparator: 2
Pancreatic Polypeptide
 Drug: Pancreatic Polypeptide (PP)
2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours.
Other Name: PP

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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 DM ≤ 8 years.
  • Not currently on pump therapy.
  • Type 1 DM who has a BMI ≥ 35.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dariush Elahi, PhD, Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier: NCT00791076     History of Changes
Other Study ID Numbers: NA_00010957
Study First Received: November 13, 2008
Last Updated: March 25, 2010
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on June 13, 2013