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

Completed · Not applicable

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT01986231

Run by

Legacy Health System

People needed

12

Starts

2011-01-01

Expected to finish

2012-12-01

Last updated by the study team

2015-05-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Oregon Health and Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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