Healthy
Conditions
Brief summary
The purpose of this study is to determine the effect of Octreotide on saliva enzymes. The study team hypothesizes that Octreotide will decrease the levels of certain proteins, specifically the metalloproteinase family.
Detailed description
This is a healthy volunteer pilot study. The purpose of this study is to determine the effect of a drug, Octreotide, on saliva enzymes in order to see if this drug can help prevent pharyngo-cutaneous fistulas (an abnormal tissue connection in the pharynx) in patients undergoing laryngectomy.
Interventions
DRUGOctreotide 1 MG/ML
100 mcg (1 ml) of Octreotide
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
This is a healthy volunteer pilot study. Subjects will be asked to provide a saliva sample after a 2 hour fast and 5 minutes after rinsing their mouth with tap water. The sample will be collected in an Eppendorf vial. After providing the saliva sample, each subject will be injected subcutaneously with 100 mcg (1 ml) of Octreotide by either a physician or registered nurse. A second sample of saliva will be collected using the same protocol 45-55 minutes after administering the drug.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults between the ages of 18-40 years old * Healthy volunteer who is willing to undergo research activities * Healthy volunteer with no self-report of disease, oral symptoms or lesions, or cold or flu like symptoms that would affect the reflective measurements in the oral cavity * Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
* Pregnant or nursing women * Children under the age of 18 or adults over 40 * Complaint of oral symptoms (self-reported) * Medical condition affecting saliva (e.g. Sjogren's) * History of head/neck radiation * Medication that might affect saliva (e.g. Proton Pump Inhibitors) * Known allergy to Octreotide * Non-English speaking * Diabetes, gallbladder disease, heart disease, high blood pressure, a heart rhythm disorder, thyroid problems, pancreatitis, kidney disease, or liver disease (self-reported)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To quantify the change of saliva proteomes of subjects pre-octreotide treatment | Day 1 pre-treatment | Saliva samples analyzed using quantitative LC/MS/MS using a nanAcquity UPLC system (Waters Corp) coupled to a Thermo Orbitrap Fusion Lumos high resolution accurate mass tandem mass spectrometer (Thermo) via a nanoelectrospray ionization source |
| To quantify the change of saliva proteomes of subjects post-octreotide treatment | Day 1 post-treatment | Saliva samples analyzed using quantitative LC/MS/MS using a nanAcquity UPLC system (Waters Corp) coupled to a Thermo Orbitrap Fusion Lumos high resolution accurate mass tandem mass spectrometer (Thermo) via a nanoelectrospray ionization source |
Countries
United States
Outcome results
None listed