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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00791076 History of Changes
Other Study ID Numbers:	NA_00010957
First Posted:	November 14, 2008
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