Study of Glucagon, Ghrelin and Growth Hormone as Counterregulatory Hormones

NCT01795235 | Unknown

• 1 other identifier: 16391
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

men

Outcome Measures

Primary Outcomes (1)

• Circulating acyl-ghrelin concentration after glucagon stimulation with and without beta-adrenergic blockade

  18 months

Secondary Outcomes (1)

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

  18 months

Study Arms (4)

Saline s.c. injection and placebo tablet

OTHER

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

Drug: Saline; Drug: Placebo

glucagon s.c. injection and placebo tablet

OTHER

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; Drug: Placebo

Saline s.c. injection and atenolol tablet

OTHER

Saline s.c. injection and 100 mg atenolol tablet

Drug: Saline; Drug: Atenolol

glucagon s.c. injection and atenolol tablet

OTHER

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

Drug: Glucagon; Drug: Atenolol

Interventions

Saline DRUG

Saline s.c.

Also known as: NormalSaline, 0.9% Sodium Chloride Solution

Saline s.c. injection and atenolol tablet; Saline s.c. injection and placebo tablet

Glucagon DRUG

Glucagon s.c.

Also known as: Glucagon for injection

glucagon s.c. injection and atenolol tablet; glucagon s.c. injection and placebo tablet

Placebo DRUG

Sugar Pill

Saline s.c. injection and placebo tablet; glucagon s.c. injection and placebo tablet

Atenolol DRUG

Beta-1 receptor antagonist

Also known as: Tenormin

Saline s.c. injection and atenolol tablet; glucagon s.c. injection and atenolol tablet

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy normal men
• Age 18-30 yrs
• BMI 18-27 kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22902, United States

RECRUITING

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Interventions

Sodium Chloride; Glucagon; Injections; Atenolol

Condition Hierarchy (Ancestors)

Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Drug Administration Routes; Drug Therapy; Therapeutics; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Michael O Thorner

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ralf Nass, MD

CONTACT

rmn9a@virginia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 12, 2013
• First Posted: February 20, 2013
• Study Start: December 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

US (1)