Back to resultsThe Effect of Pancreatic Polypeptide on Insulin Requirements for Type 1 & Post-pancreatectomy Diabetic Patients
Primary Purpose
Diabetes Mellitus, Type 1
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Pancreatic Polypeptide (PP)
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Insulin pump therapy, Type 1 diabetic, Chronic pancreatitis, Pancreatic resection, Pancreatic polypeptide
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.
Sites / Locations
- Johns Hopkins Bayview Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Saline Placebo
Pancreatic Polypeptide
Arm Description
Saline
Pancreatic Polypeptide
Outcomes
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.
Secondary Outcome Measures
Frequency of Hypoglycemia Defined as < 60 mg/dl.
Full Information
NCT ID
NCT00791076
First Posted
November 13, 2008
Last Updated
June 29, 2017
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT00791076
Brief Title
The Effect of Pancreatic Polypeptide on Insulin Requirements for Type 1 & Post-pancreatectomy Diabetic Patients
Official Title
The Effect of Pancreatic Polypeptide on Insulin Requirements for Type 1 (Auto-immune) and Post-pancreatectomy Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
PI left JHU
Study Start Date
October 2007 (Actual)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Insulin pump therapy, Type 1 diabetic, Chronic pancreatitis, Pancreatic resection, Pancreatic polypeptide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saline Placebo
Arm Type
Placebo Comparator
Arm Description
Saline
Arm Title
Pancreatic Polypeptide
Arm Type
Active Comparator
Arm Description
Pancreatic Polypeptide
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
2pmol/kg-1/min-1 placebo infused continuously over 72 hours.
Intervention Type
Drug
Intervention Name(s)
Pancreatic Polypeptide (PP)
Other Intervention Name(s)
PP
Intervention Description
2pmol/kg-1/min-1 PP infused continuously over 72 hours.
Primary Outcome Measure Information:
Title
Total Amount of Insulin Administered While on Placebo/PP.
Description
Glucose values and the pattern of glycemic excursions over the 72 hour test period.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Frequency of Hypoglycemia Defined as < 60 mg/dl.
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dariush Elahi, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of Pancreatic Polypeptide on Insulin Requirements for Type 1 & Post-pancreatectomy Diabetic Patients
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