Measuring Glucagon Kinetics in Humans

Overview

About this study

Our goal in this pilot study is to test and develop a novel method that will accurately measure, in vivo, glucagon kinetics in healthy humans and generate preliminary data in type 1 diabetes (T1DM) subjects under overnight fasted conditions.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age 18-50 years
  • BMI 19-30 kg/m2
  • Creatinine ≤ 1.5 mg/dl
  • No hypoglycemia unawareness by clinical history
  • current non-smoker
  • alcohol consumption <5 g/week
  • for women of child bearing potential, negative pregnancy test
  • no eating disorder
  • no current substance abuse
  • HbA1c ≤ 9% in T1DM subjects and < 5.7% in healthy nondiabetic subjects.
  • normal fasting glucose (70-99 mg/dl) in healthy subjects
  • On insulin pump therapy for at least six months for T1DM subjects
  • no symptomatic gastroparesis
  • no unstable retinopathy (requiring photocoagulation within past 6 months)

Exclusion Criteria:

  • Admission for diabetic ketoacidosis in the 12 months prior to enrollment
  • Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
  • History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist
  • Coronary artery disease or heart failure.
  • History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted)
  • Cystic fibrosis
  • A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
    • Inpatient psychiatric treatment in the past 6 months
    • Presence of a known adrenal disorder
    • Abnormal liver function test results (Transaminase >2 times the upper limit of normal);
    • Abnormal renal function test results (creatinine > 1.5 mg/dl);
    • Active gastroparesis or on medications for gastroparesis
    • If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
    • Uncontrolled thyroid disease (TSH undetectable or >10 mlU/L)
    • Abuse of alcohol or recreational drugs
  • Current use of the following drugs and supplements:
    • Any medication other than insulin, being taken to lower blood glucose, such as Pramlintide, Metformin, GLP-1 Analogs such as Liraglutide, and nutraceuticals intended to lower blood glucose
    • Oral or injectable glucocorticoids
    • Any other medication that the investigator believes is a contraindication to the subject’s participation

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Kelly Dunagan, R.N.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20306511

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