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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00179023 |
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Date of registration:
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13/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Autonomic Nervous System and Obesity
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Scientific title:
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The Autonomic Nervous System and Obesity |
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Date of first enrolment:
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April 2003 |
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Target sample size:
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128 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00179023 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Italo Biaggioni, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vanderbilt University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy normal (BMI <= 25 Kg/m2), obese (BMI between 30 and 40)volunteers, lean
hypertensive (BMI 20-28 Kg/m2), and obese hypertensive (BMI between 30 and 40)
- Ages 18-60
- Patients with pure autonomic failure and multiple system atrophy ages 18-80, referred
to our service for the diagnosis and treatment of their condition, and their age
sex-matched sedentary, healthy controls ages 18-80
Exclusion criteria:
- All medical students
- Pregnant women
- Heart failure, symptomatic coronary artery disease, liver impairment, history of
stroke or myocardial infarction, glaucoma
- History of serious allergies or asthma
- Subjects using beta-blockers
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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OBESITY
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HYPERTENSION
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PURE AUTONOMIC FAILURE
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SHY-DRAGER SYNDROME
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Intervention(s)
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Drug: Pseudoephedrine
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Drug: Trimethaphan
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Primary Outcome(s)
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Change in supine systolic blood pressure after achieving complete ganglionic blockade.
[Time Frame: 1-2 hour]
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Secondary Outcome(s)
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Change in resting energy expenditure after achieving complete autonomic blockade.
[Time Frame: 1-2 hour]
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Secondary ID(s)
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020548
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HL56693
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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