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Trial record 67 of 116 for:    Atenolol

Study of Glucagon, Ghrelin and Growth Hormone as Counterregulatory Hormones

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ClinicalTrials.gov Identifier: NCT01795235
Recruitment Status : Unknown
Verified February 2013 by Michael Thorner, MD, University of Virginia.
Recruitment status was:  Recruiting
First Posted : February 20, 2013
Last Update Posted : February 20, 2013
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Michael Thorner, MD, University of Virginia

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 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Saline Drug: Glucagon Drug: Placebo Drug: Atenolol Not Applicable

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 subsequent decline in glucose, insulin and glucagon was followed by an increase in cortisol and GH. Ghrelin is a 28 amino acid peptide which is released from the fundus of the stomach, within the oxyntic glands and the small intestine. It circulates in two major forms, acylated and des-acylated ghrelin. Acylated ghrelin has strong GH-releasing effects which are mediated via the G-protein coupled ghrelin receptor. The proposed study will test the concept that with the fall in blood glucose during a glucagon test 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Glucagon, Ghrelin and Growth Hormone as Counterregulatory Hormones
Study Start Date : December 2012
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Saline s.c. injection and placebo tablet
Saline s.c. injection and one placebo tablet (preceded by one placebo tablet per day at 0900h for two days before admission).
Drug: Saline
Saline s.c.
Other Names:
  • NormalSaline
  • 0.9% Sodium Chloride Solution

Drug: Placebo
Sugar Pill

glucagon s.c. injection and placebo tablet
1 mg glucagon s.c. injection and one placebo tablet (preceded by one placebo tablet per day at 0900h for two days before admission).
Drug: Glucagon
Glucagon s.c.
Other Name: Glucagon for injection

Drug: Placebo
Sugar Pill

Saline s.c. injection and atenolol tablet
Saline s.c. injection and 100 mg atenolol tablet
Drug: Saline
Saline s.c.
Other Names:
  • NormalSaline
  • 0.9% Sodium Chloride Solution

Drug: Atenolol
Beta-1 receptor antagonist
Other Name: Tenormin

glucagon s.c. injection and atenolol tablet
1 mg glucagon s.c. injection and 100 mg atenolol tablet
Drug: Glucagon
Glucagon s.c.
Other Name: Glucagon for injection

Drug: Atenolol
Beta-1 receptor antagonist
Other Name: Tenormin




Primary Outcome Measures :
  1. Circulating acyl-ghrelin concentration after glucagon stimulation with and without beta-adrenergic blockade [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Association between circulating acyl-ghrelin concentration and GH and cortisol after glucagon administration with and without beta-adrenergic blockade [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01795235


Contacts
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Contact: Ralf Nass, MD rmn9a@virginia.edu

Locations
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United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22902
Contact: Ralf Nass, MD       rmn9a@virginia.edu   
Principal Investigator: Michael O Thorner         
Sponsors and Collaborators
University of Virginia
Novo Nordisk A/S
Investigators
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Principal Investigator: Michael O Thorner University of Virginia

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Responsible Party: Michael Thorner, MD, MD, University of Virginia
ClinicalTrials.gov Identifier: NCT01795235     History of Changes
Other Study ID Numbers: 16391
First Posted: February 20, 2013    Key Record Dates
Last Update Posted: February 20, 2013
Last Verified: February 2013
Keywords provided by Michael Thorner, MD, University of Virginia:
men
Additional relevant MeSH terms:
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Atenolol
Glucagon
Hormones
Glucagon-Like Peptide 1
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Gastrointestinal Agents
Incretins
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action