Diabetes Mellitus, Type 1
Conditions
Keywords
Insulin pump therapy, Type 1 diabetic, Chronic pancreatitis, Pancreatic resection, Pancreatic polypeptide
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.
Interventions
DRUGPlacebo
2pmol/kg-1/min-1 placebo infused continuously over 72 hours.
2pmol/kg-1/min-1 PP infused continuously over 72 hours.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Amount of Insulin Administered While on Placebo/PP. | 2 years | Glucose values and the pattern of glycemic excursions over the 72 hour test period. |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of Hypoglycemia Defined as < 60 mg/dl. | 72 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants 2pmol/kg-1/min-1 saline infused continuously over 72 hours OR
2pmol/kg-1/min-1 PP infused continuously over 72 hours. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study was terminated,PI left institution | 8 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Customized >=18 and <=75 | 8 participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Population: Data was not collected for this outcome measure. The P.I. left the institution and the study was terminated.
Secondary
Frequency of Hypoglycemia Defined as < 60 mg/dl.
Time frame: 72 hours
Population: The PI left the institution and this study was terminated due to noncompliance with our Institutional Review Board. Data, if collected,is unknown since no data are available.