N/A
N=12
Safety Study of Repeated Doses of Glucagon on Animal Starch in the Liver
Type 1 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01986231 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Assess Difference in Hepatic Glycogen Measured in the Fasting State Before vs. After Repeated Glucagon Administration — 6.5 g/L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Glucagon (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Legacy Health System
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assess Difference in Hepatic Glycogen Measured in the Fasting State Before vs. After Repeated Glucagon Administration |
6.5 | — |
| SECONDARY Assess Difference in Hepatic Glycogen Measured in the Fed State Before vs. After Repeated Glucagon Administration |
10.6 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01986231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.