Measuring Glucagon Kinetics in Humans
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 15-006011
Sponsor Protocol Number: 15-006011
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.
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.
- 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)
- 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
Mayo Clinic principal investigator
Kelly Dunagan, R.N.
Closed for enrollment
Publications are currently not available