NCT00179023

The Autonomic Nervous System and Obesity

Completed Phase 1 Last updated 27 February 2018

What this trial tests

Phase 1 trial testing Trimethaphan in OBESITY in 128 participants. Completed in 1 January 2017.

Timeline

1 April 2003

Primary endpoint
1 January 2017

1 January 2017

Quick facts

Lead sponsor	Vanderbilt University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	128
Start date	1 April 2003
Primary completion	1 January 2017
Estimated completion	1 January 2017
Sites	1 location across United States

Drugs / interventions tested

• Trimethaphan — full drug profile →
• Trimethaphan — full drug profile →
• Pseudoephedrine (pseudoephedrine) — full drug profile →

Conditions studied

• OBESITY — all drugs for OBESITY →
• HYPERTENSION — all drugs for HYPERTENSION →
• PURE AUTONOMIC FAILURE — all drugs for PURE AUTONOMIC FAILURE →
• SHY-DRAGER SYNDROME — all drugs for SHY-DRAGER SYNDROME →

Sponsor

Vanderbilt University

Who can join

Adults 18 to 80, any sex, with OBESITY or HYPERTENSION. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in supine systolic blood pressure after achieving complete ganglionic blockade.
  Time frame: 1-2 hour

Sponsor's own description

In its simplest terms, obesity is the results of a positive balance between food intake and energy expenditure (EE). I.e., we take in more energy, in the form of food, than we expend, e.g., by exercise. In our sedentary society, resting EE accounts for most of total energy expenditure. The sympathetic nervous system (SNS, the one that produces adrenaline) is thought to contribute to resting EE. This conclusion is based on experiments where resting EE is decreased by beta-blockers, high blood pressure medicines that block only one aspect of the sympathetic nervous system. The investigators propose to use a different approach, by using a medication called trimethaphan that produces transient withdrawal of the autonomic nervous system. The investigators will then compare the measured resting EE before and after SNS withdraw and quantify the degree of contribution to the resting EE by the SNS and delineate differences between healthy normal, healthy obese, and patients with autonomic dysfunctions.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hypertension in Obese Black Women is Not Caused by Increased Sympathetic Vascular Tone.
   Marinos A, Gamboa A, Celedonio JE, Preheim BA, et al · · 2017 · cited 14× · PMID 29151035 · DOI 10.1161/jaha.117.006971
2. Chronic sympathetic attenuation and energy metabolism in autonomic failure.
   Shibao C, Buchowski MS, Chen KY, Yu C, et al · · 2012 · cited 5× · PMID 22469621 · DOI 10.1161/hypertensionaha.111.190157