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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00791076
• Other study ID #: NA_00010957
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 13, 2008
• Last updated: March 25, 2010
• Start date: October 2007
• Est. completion date: June 2011

Study information

• Verified date: March 2010
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: June 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Drug:
• Placebo
2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours.
• Pancreatic Polypeptide (PP)
2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total amount of insulin administered while on placebo/PP. Glucose values and the pattern of glycemic excursions over the 72 hour test period.		2 years	No
Secondary	Frequency of hypoglycemia defined as < 60 mg/dl.		72 hours	No