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glucagon s.c. injection and atenolol tablet for Healthy Subjects
N/A
Waitlist Available
Led By Michael O Thorner
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
Study 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 to be stimulated by an increase in adrenergic activity. The proposed study will test the concept that with the fall in blood glucose it is likely that there is a sympathetic discharge which contributes to the increase in acyl ghrelin and indirectly leads to the increase in GH and cortisol.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Circulating acyl-ghrelin concentration after glucagon stimulation with and without beta-adrenergic blockade
Secondary outcome measures
Association between circulating acyl-ghrelin concentration and GH and cortisol after glucagon administration with and without beta-adrenergic blockade
Trial Design
4Treatment groups
Experimental Treatment
Group I: glucagon s.c. injection and placebo tabletExperimental Treatment2 Interventions
1 mg glucagon s.c. injection and one placebo tablet (preceded by one placebo tablet per day at 0900h for two days before admission).
Group II: glucagon s.c. injection and atenolol tabletExperimental Treatment2 Interventions
1 mg glucagon s.c. injection and 100 mg atenolol tablet
Group III: Saline s.c. injection and placebo tabletExperimental Treatment2 Interventions
Saline s.c. injection and one placebo tablet (preceded by one placebo tablet per day at 0900h for two days before admission).
Group IV: Saline s.c. injection and atenolol tabletExperimental Treatment2 Interventions
Saline s.c. injection and 100 mg atenolol tablet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sodium chloride
FDA approved
Placebo
1995
Completed Phase 3
~2670
Glucagon
FDA approved
Atenolol
FDA approved
Find a Location
Who is running the clinical trial?
Novo Nordisk A/SIndustry Sponsor
1,514 Previous Clinical Trials
2,415,062 Total Patients Enrolled
University of VirginiaLead Sponsor
754 Previous Clinical Trials
1,245,067 Total Patients Enrolled
Michael O ThornerPrincipal InvestigatorUniversity of Virginia
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