Status:
UNKNOWN
Study of Glucagon, Ghrelin and Growth Hormone as Counterregulatory Hormones
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Healthy
Eligibility:
MALE
18-30 years
Phase:
NA
Brief Summary
Glucagon has been used for decades as a test of growth hormone (GH) reserve. The pathway by which GH is stimulated by glucagon is not established. Acyl ghrelin has been shown to increase GH levels and...
Detailed Description
Glucagon given to healthy adults in doses of 1-1.5 mg i.m. has been shown to result in a peak glucagon level in the circulation after 30 min, followed by an increase in glucose and insulin levels. The...
Eligibility Criteria
Inclusion
- Healthy normal men
- Age 18-30 yrs
- BMI 18-27 kg/m2
Exclusion
- Medication or previous surgery known to affect ghrelin secretion.
- Medications known to have an impact on body weight (Seroquel, tricyclic antidepressants).
- Medications known to have an impact on the beta adrenergic system.
- Coronary artery disease, congestive heart failure, peripheral vascular disease, diabetes mellitus, significant hypertension (BP \>180 systolic or \>100 diastolic at rest); renal, hepatic, pulmonary disease; untreated hypothyroidism, untreated hyperthyroidism; history of seizure disorder; history of malignancy (other than some skin cancers), history of active chronic infections (e.g., HIV, tuberculosis).
- Endocrine disorders, i.e., pheochromocytoma, adrenal insufficiency
- Hematocrit \< 41% men
- History of daily tobacco use within past 3 months
- Chronic alcohol abuse by history
- Weight not stable (more than 10% weight change or more over past 6 months)
- Strenuous exercise for average of more than 60 min/day
- Investigational drug within past 6 weeks
- Psychiatric history especially eating disorders
- Transmeridian travel within 2 weeks prior to or during study
- Known hypersensitivity to beta-blockers
- Estimated Glomerular Filtration Rate below 60 mL/min/1.73m2.
- Known cardiac dysrhythmia, especially first degree heart block. -
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2014
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01795235
Start Date
December 1 2012
End Date
July 1 2014
Last Update
February 20 2013
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22902