Safety Study of Repeated Doses of Glucagon on Animal Starch in the Liver

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to learn if giving multiple doses of a hormone called glucagon can cause a major decrease in liver glycogen (animal starch). Glucagon is currently approved by the Food and Drug Administration to be given as a large dose to treat severe low blood sugar. Our group is studying whether glucagon can be given in repeated small doses to prevent hypoglycemia.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Legacy Health System
• Collaborators: Juvenile Diabetes Research Foundation; Oregon Health and Science University
• Treatments: Glucagon; Glucagon-Like Peptide 1

Criteria

Inclusion Criteria:

• Type 1 diabetes mellitus diagnosed for at least 6 months

• Current usage of subcutaneous insulin pump treatment

• Age 18-65 years

• HbA1c of 5.5 - 7.7% at screening visit

• BMI 18-35 kg/m2

• Willingness to follow all study procedures, including attending all clinic visits

• Willingness to sign informed consent and HIPAA documents

Exclusion Criteria:

• Pregnancy or Lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test.

• Renal insufficiency (serum creatinine of 2.0 mg/dL or greater).

• Serum ALT or AST equal to or greater than 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as a serum albumin of less than 3.3 g/dL; or serum bilirubin of over 2.

• Hematocrit of less than or equal to 34%.

• Congestive heart failure, NYHA class II, III or IV.

• Coronary artery or cerebrovascular disease.

• Active foot ulceration.

• Active alcohol abuse, substance abuse, or severe mental illness (as judged by the principal investigator).

• Active malignancy, except basal cell or squamous cell skin cancers.

• Major surgical operation within 30 days prior to screening.

• Seizure disorder (epilepsy).

• Contraindication to an MRI scan, including having metallic splinters in the eye, a cardiac pacemaker, defibrillator, or any other ferromagnetic or electronically charged implanted device, or ferromagnetic clip(s) in the central nervous system.

• Currently administration of oral or parenteral corticosteroids.

• Use of an investigational drug within 30 days prior to screening.

• Bleeding disorder, treatment with warfarin, or platelet count below 50,000.

• History weight loss of ≥ 5 lbs over the prior month.

• Weight ≥ 300 lbs.

• Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen.

• Any reason the principal investigator deems exclusionary.