TerminatedPhase 2

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

Stopped: PI left JHU

United States8 participantsStarted 2007-10

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Total Amount of Insulin Administered While on Placebo/PP.

Timeframe: 2 years

Trial details

NCT IDNCT00791076

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-06

Results submitted2017-05-01