Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 1
Treatments placebo, pancreatic polypeptide (pp)
Phase phase 2
Sponsor Johns Hopkins University
Start date October 2007
End date June 2010
Trial size 20 participants
Trial identifier NCT00791076, NA_00010957

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Placebo Comparator)
Saline
placebo Saline
2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours.
(Active Comparator)
Pancreatic Polypeptide
pancreatic polypeptide (pp) PP
2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Frequency of hypoglycemia defined as < 60 mg/dl.
time frame: 72 hours

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Official title The Effect of Pancreatic Polypeptide on Insulin Requirements for Type 1 (Auto-immune) and Post-pancreatectomy Diabetic Patients
Principal investigator Dariush Elahi, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by Johns Hopkins University.