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

NCT01986231 | Completed Results DMC

• 1 other identifier: IRB00006947
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes Mellitus

Keywords

diabetes; insulin; glucagon; glycogen; MRS

Outcome Measures

Primary Outcomes (1)

• Assess Difference in Hepatic Glycogen Measured in the Fasting State Before vs. After Repeated Glucagon Administration

  The mean difference in estimated hepatic glycogen will be assessed using Carbon 13 Magnetic Resonance Spectroscopy before vs. after glucagon administration in the fasting state.

  Baseline and 41 hours

Secondary Outcomes (1)

• Assess Difference in Hepatic Glycogen Measured in the Fed State Before vs. After Repeated Glucagon Administration

  Baseline and 41 hours

Study Arms (1)

Open-Label Glucagon

EXPERIMENTAL

Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg.

Drug: Glucagon

Interventions

Glucagon DRUG

Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.

Also known as: GlucaGen

Open-Label Glucagon

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Legacy Health System: lead
• Juvenile Diabetes Research Foundation: collaborator
• Oregon Health and Science University: collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Castle JR, El Youssef J, Bakhtiani PA, Cai Y, Stobbe JM, Branigan D, Ramsey K, Jacobs P, Reddy R, Woods M, Ward WK. Effect of Repeated Glucagon Doses on Hepatic Glycogen in Type 1 Diabetes: Implications for a Bihormonal Closed-Loop System. Diabetes Care. 2015 Nov;38(11):2115-9. doi: 10.2337/dc15-0754. Epub 2015 Sep 4.

  PMID: 26341131 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Insulin Resistance

Interventions

Glucagon; Glucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Glucagon-Like Peptides; Gastrointestinal Hormones

Results Point of Contact

• Title: Kenneth Ward
• Organization: Legacy Health System

kenward503@msn.com

971-570-2632

Study Officials

• W Kenneth Ward, MD

  Legacy Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 18, 2013
• Study Start: January 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 4, 2015
• Results First Posted: April 30, 2015

Record last verified: 2015-04

Locations

US (1)