Suspended

Glucagon, Ghrelin and Growth Hormone as Counterregulatory Hormones

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What is being tested

Saline

+ Placebo

+ Glucagon

Drug
Who is being recruted

Endocrine System Diseases+7

+ Endocrine Gland Neoplasms

+ Congenital, Hereditary, and Neonatal Diseases and Abnormalities

From 18 to 30 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: December 2012
See protocol details

Summary

Principal SponsorUniversity of Virginia
Study ContactRalf Nass, MDMore contacts
Last updated: February 20, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01795235
Principal SponsorUniversity of Virginia
Study ContactRalf Nass, MDMore contacts
Last updated: February 20, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

6 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 30 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesEndocrine Gland NeoplasmsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplasmsNeoplasms by SiteMultiple Endocrine NeoplasiaNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornMultiple Endocrine Neoplasia Type 1

Criteria

3 inclusion criteria required to participate
Age 18-30 yrs
BMI 18-27 kg/m2
Healthy normal men
16 exclusion criteria prevent from participating
Chronic alcohol abuse by history
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
Estimated Glomerular Filtration Rate below 60 mL/min/1.73m2
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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 III

Saline s.c. injection and 100 mg atenolol tablet

Group IV

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University of Virginia

Charlottesville, United StatesOpen University of Virginia in Google Maps
SuspendedOne Study Center