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Healthy | Study of Glucagon, Ghrelin and Growth Hormone as Counterregulatory Hormones

Healthy research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: 1. Healthy normal men 2. Age 18-30 yrs 3. BMI 18-27 kg/m2 Exclusion Criteria: 1. Medication or previous surgery known to affect ghrelin secretion. 2. Medications known to have an impact on body weight (Seroquel, tricyclic antidepressants). 3. Medications known to have an impact on the beta adrenergic system. 4. 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). 5. Endocrine disorders, i.e., pheochromocytoma, adrenal insufficiency 6. Hematocrit < 41% men 7. History of daily tobacco use within past 3 months 8. Chronic alcohol abuse by history 9. Weight not stable (more than 10% weight change or more over past 6 months) 10. Strenuous exercise for average of more than 60 min/day 11. Investigational drug within past 6 weeks 12. Psychiatric history especially eating disorders 13. Transmeridian travel within 2 weeks prior to or during study 14. Known hypersensitivity to beta-blockers 15. Estimated Glomerular Filtration Rate below 60 mL/min/1.73m2. 16. Known cardiac dysrhythmia, especially first degree heart block. -

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Healthy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:SalineSaline s.c.

Drug:GlucagonGlucagon s.c.

Drug:PlaceboSugar Pill

Drug:AtenololBeta-1 receptor antagonist

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Saline s.c. injection and placebo tabletSaline s.c. injection and one placebo tablet (preceded by one placebo tablet per day at 0900h for two days before admission).

glucagon s.c. injection and placebo tablet1 mg glucagon s.c. injection and one placebo tablet (preceded by one placebo tablet per day at 0900h for two days before admission).

Saline s.c. injection and atenolol tabletSaline s.c. injection and 100 mg atenolol tablet

glucagon s.c. injection and atenolol tablet1 mg glucagon s.c. injection and 100 mg atenolol tablet

Study Status

Unknown status

Start Date: December 2012

Completed Date: July 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Circulating acyl-ghrelin concentration after glucagon stimulation with and without beta-adrenergic blockade

Secondary Outcome: Association between circulating acyl-ghrelin concentration and GH and cortisol after glucagon administration with and without beta-adrenergic blockade

Study sponsors, principal investigator, and references

Principal Investigator: Michael O Thorner

Lead Sponsor: University of Virginia

Collaborator: Novo Nordisk A/S

More information:https://clinicaltrials.gov/show/NCT01795235

Discuss Atenolol