CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 56 enrolled
Drug / intervention
Blocked +1 moredrug
Likely dose
Blocked 4 mgfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00580957
NCT00580957N/ACompleted

The Autonomic Nervous System and the Metabolic Syndrome

Vanderbilt University·interventional·Posted Dec 27, 2007·Updated Aug 5, 2016

In Brief

A clinical study evaluating Blocked and Intact for Obesity. Completed, enrolled 56 participants across 1 site.

Detailed Summary

The overall goal of this proposal is to determine the role of the autonomic nervous system in the insulin resistant state associated with obesity and the metabolic syndrome. Obesity results from an accumulation of excessive fat deposit due to increase caloric intake or decrease energy expenditure, this condition is usually associated with diseases such as hypertension or diabetes, a cluster known as the metabolic syndrome. The first step in the development of the metabolic syndrome is a resistance to the action of insulin. The mechanism underlying insulin resistance in obesity is still unknown, however some investigators have proposed that the autonomic nervous system, particularly the increase sympathetic activation in obesity may play an important role. We have extensive experience studying the role of the autonomic nervous system in the cardiovascular alterations associated with obesity by producing complete autonomic withdrawal with a drug named trimethaphan. We propose to use the same approach to study the role of the autonomic nervous system in the development of insulin resistance in obesity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 27, 2007
Enrollment StartAug 1, 2008
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 18.5 years ago

Interventions

Blockeddrug

Trimethaphan 4 mg/min IV will be infused for the duration of the study. L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance

Intactdrug

Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance