Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
1996-12-31
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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A
Patients with Orthostatic Hypotension
Standing or upright tilt
stand upright or tilt table test
Microneurography
Recording from sympathetic nerve
QSweat
quantitative sweat testing
neck cuff stimulation
Blood pressure receptors in the neck arteries may be stimulated by applying suction through a collar around the neck.
phenylephrine,isoproterenol,nitroprusside,propranolol,edrophonium,atropine,tyramine
IV Pharmacological Testing
phenylephrine 12.5 - 400 ug, isoproterenol 0.1 - 0.4 ug or higher until desired effect, nitroprusside 0.1 - 1.6 ug/kg, propranolol 1.1 mg/min, edrophonium maximum of 10 mg, atropine .01 mg/kg, tyramine 250-4000 ug or higher until desired effect
clonidine,yohimbine,metoclopramide,alpha-methyldopa
Oral Pharmacological Testing
clonidine 0.1-0.3 mg, yohimbine 5-10 mg, metoclopramide 10 mg, alpha-methyldopa 62.5 mg, placebo
BodPod
Determination of body composition
Eye exam
Examination of pressure in the eye and eyelid fatiguability. The following eyedrops might be used:
1. 0.5% proparacaine (Alcaine, Allergan, Inc)
2. Fluress (0.4% benoxinate hydrochloride, fluorescein sodium, Akorn, Inc)
3. 0.5%, 1% tropicamide (Mydriacyl, Alcon)
4. Over-the-counter preservative-free artificial tears
5. 0.25%, 2.5% and 10% phenylephrine (Bausch and Lomb)
6. 1% cyclopentolate hydrochloride (Alcon)
Sleep study
Recording of sleep pattern overnight
Pain response testing
Subjects will rate the quality and intensity of 2 pain tasks.
Metabolic chamber
Determination of metabolic rate via 24hr stay in whole-room indirect calorimeter
Brain function studies
Questionnaires and computer tasks, an EEG and an MRI may be used to assess brain function.
Bicycle Exercise Test
Blood pressure and heart rate may be monitored while exercising on a stationary bicycle.
Interventions
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Standing or upright tilt
stand upright or tilt table test
Microneurography
Recording from sympathetic nerve
QSweat
quantitative sweat testing
neck cuff stimulation
Blood pressure receptors in the neck arteries may be stimulated by applying suction through a collar around the neck.
phenylephrine,isoproterenol,nitroprusside,propranolol,edrophonium,atropine,tyramine
IV Pharmacological Testing
phenylephrine 12.5 - 400 ug, isoproterenol 0.1 - 0.4 ug or higher until desired effect, nitroprusside 0.1 - 1.6 ug/kg, propranolol 1.1 mg/min, edrophonium maximum of 10 mg, atropine .01 mg/kg, tyramine 250-4000 ug or higher until desired effect
clonidine,yohimbine,metoclopramide,alpha-methyldopa
Oral Pharmacological Testing
clonidine 0.1-0.3 mg, yohimbine 5-10 mg, metoclopramide 10 mg, alpha-methyldopa 62.5 mg, placebo
BodPod
Determination of body composition
Eye exam
Examination of pressure in the eye and eyelid fatiguability. The following eyedrops might be used:
1. 0.5% proparacaine (Alcaine, Allergan, Inc)
2. Fluress (0.4% benoxinate hydrochloride, fluorescein sodium, Akorn, Inc)
3. 0.5%, 1% tropicamide (Mydriacyl, Alcon)
4. Over-the-counter preservative-free artificial tears
5. 0.25%, 2.5% and 10% phenylephrine (Bausch and Lomb)
6. 1% cyclopentolate hydrochloride (Alcon)
Sleep study
Recording of sleep pattern overnight
Pain response testing
Subjects will rate the quality and intensity of 2 pain tasks.
Metabolic chamber
Determination of metabolic rate via 24hr stay in whole-room indirect calorimeter
Brain function studies
Questionnaires and computer tasks, an EEG and an MRI may be used to assess brain function.
Bicycle Exercise Test
Blood pressure and heart rate may be monitored while exercising on a stationary bicycle.
Eligibility Criteria
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Inclusion Criteria
* non-smokers
* drug-free
* able to give informed consent
* free of pulmonary, renal, hematopoietic, hepatic and cardiac disease
Exclusion Criteria
* any chronic illness
* anemia (Hct\<30)
* women of childbearing age who are pregnant or nursing
* smokers
12 Years
70 Years
ALL
No
Sponsors
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Vanderbilt University Medical Center
OTHER
Responsible Party
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Emily M. Garland
Research Associate Professor
Principal Investigators
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Emily M Garland, PhD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University
Locations
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Vanderbilt University
Nashville, Tennessee, United States
Countries
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References
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Arnold AC, Garland EM, Celedonio JE, Raj SR, Abumrad NN, Biaggioni I, Robertson D, Luther JM, Shibao CA. Hyperinsulinemia and Insulin Resistance in Dopamine beta-Hydroxylase Deficiency. J Clin Endocrinol Metab. 2017 Jan 1;102(1):10-14. doi: 10.1210/jc.2016-3274.
Other Identifiers
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HL056693
Identifier Type: -
Identifier Source: secondary_id
030752
Identifier Type: -
Identifier Source: org_study_id
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