HealthyNCT01795235
Study of Glucagon, Ghrelin and Growth Hormone as Counterregulatory Hormones
A study testing Saline, Glucagon and Atenolol in people with Healthy, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Saline, Glucagon and Atenolol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy normal men
- Age 18-30 yrs
- BMI 18-27 kg/m2
Who cannot join
- 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
Show all 16Show fewer
- 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. -
Trial locations and contacts
1 site in 1 country.
Ralf Nass, MD contact
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22902
Ralf Nass, MD, rmn9a@virginia.edu
Michael O Thorner
About this study
Official title: Glucagon, Ghrelin and Growth Hormone as Counterregulatory Hormones
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Saline, Glucagon, Placebo, Atenolol
- Keywords
- men
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
Also called NormalSaline, 0.9% Sodium Chloride Solution
Saline s.c.
GlucagonDrug
Also called Glucagon for injection
Glucagon s.c.
PlaceboDrug
Sugar Pill
AtenololDrug
Also called Tenormin
Beta-1 receptor antagonist
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Glucagon; Drug: Placebo |
| Saline s.c. injection and atenolol tablet | Other | Saline s.c. injection and 100 mg atenolol tablet Receives: Drug: Saline; Drug: Atenolol |
| glucagon s.c. injection and atenolol tablet | Other | 1 mg glucagon s.c. injection and 100 mg atenolol tablet Receives: Drug: Glucagon; Drug: Atenolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating acyl-ghrelin concentration after glucagon stimulation with and without beta-adrenergic blockade
Measured: 18 months
Secondary outcomes (1)
Association between circulating acyl-ghrelin concentration and GH and cortisol after glucagon administration with and without beta-adrenergic blockade
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Michael Thorner, MD, University of Virginia
- Investigators
- Michael O Thorner, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795235
- Sponsor's protocol ID
- 16391
- Status last verified
- Feb 2013
- First submitted
- 12 Feb 2013
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucagon, Ghrelin and Growth Hormone as Counterregulatory Hormones
- ClinicalTrials.gov ID
- NCT01795235
- Acronym / sponsor ID
- 16391
- Conditions
- Healthy
- Keywords
- men
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Dec 2012
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 20 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Saline s.c. injection and placebo tablet | Other | Drug: Saline, Drug: PlaceboSaline 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 tablet | Other | Drug: Glucagon, Drug: Placebo1 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 tablet | Other | Drug: Saline, Drug: AtenololSaline s.c. injection and 100 mg atenolol tablet |
| glucagon s.c. injection and atenolol tablet | Other | Drug: Glucagon, Drug: Atenolol1 mg glucagon s.c. injection and 100 mg atenolol tablet |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy normal men
- Age 18-30 yrs
- BMI 18-27 kg/m2
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SalineAlso: NormalSaline, 0.9% Sodium Chloride SolutionSaline s.c. | Drug | Saline s.c. injection and atenolol tablet, Saline s.c. injection and placebo tablet |
| GlucagonAlso: Glucagon for injectionGlucagon s.c. | Drug | glucagon s.c. injection and atenolol tablet, glucagon s.c. injection and placebo tablet |
| PlaceboSugar Pill | Drug | Saline s.c. injection and placebo tablet, glucagon s.c. injection and placebo tablet |
| AtenololAlso: TenorminBeta-1 receptor antagonist | Drug | Saline s.c. injection and atenolol tablet, glucagon s.c. injection and atenolol tablet |
Primary outcome
Circulating acyl-ghrelin concentration after glucagon stimulation with and without beta-adrenergic blockade
Time frame: 18 months
1 secondary outcome
Association between circulating acyl-ghrelin concentration and GH and cortisol after glucagon administration with and without beta-adrenergic blockade
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralf Nass, MD contact
Michael O Thorner principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline, Glucagon and Atenolol in people with Healthy, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ralf Nass, MD (rmn9a@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating acyl-ghrelin concentration after glucagon stimulation with and without beta-adrenergic blockade (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2013.