Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00179023
Status:
COMPLETED
Last Update Posted:
2018-03-01
First Post:
2005-09-13
Brief Title:
The Autonomic Nervous System and Obesity
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
The Autonomic Nervous System and Obesity
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In its simplest terms obesity is the results of a positive balance between food intake and energy expenditure EE Ie we take in more energy in the form of food than we expend eg 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
Detailed Description:
The rationale for this study is that even small alterations to energy metabolism can significantly change energy balance and body weight in the long term We will test the hypothesis that the sympathetic nervous system SNS activity contributes to resting and thermogenic components of energy expenditure EE
This study is divided in four different parts 1 2 3 4
Part 1 we will gauge the contribution of the sympathetic nervous system to resting energy expenditure blood pressure and determine differences between lean obese and patients with primary autonomic failure
Part 2 we will determine the degree of sympathetic blockade by a gradual infusion of the ganglionic blocker trimethaphanPart 2 has been closed
Part 3 we will determine the energy balance in patients with primary autonomic failure
Part 4 we will determine the contribution of the sympathetic nervous system to lipolysisPart 4 has been closed
Subjects selections
For part 1 and 2 we will study six groups of subjects n 40 for each group patients with pure autonomic failure patients with multiple system atrophy healthy normal controls BMI 25 obese controls BMI 30-40 and obese hypertensive BMI 30-40 and lean hypertensive BMI 20-28 A time interval of at least 1 week is required for those subjects who wish to participate in part 1 and part 2 For part 3 we will study two groups of subjects n12 for each group patients with autonomic failure and their age sex-matched sedentary healthy controls For part 4 we will study two groups of subjects n12 for each group healthy normal controls BMI 20-25 obese controls BMI 30-40
Part 2 and 4 have been closed
This study is divided in four different parts 1 2 3 4
Part 1 we will gauge the contribution of the sympathetic nervous system to resting energy expenditure blood pressure and determine differences between lean obese and patients with primary autonomic failure
Part 2 we will determine the degree of sympathetic blockade by a gradual infusion of the ganglionic blocker trimethaphanPart 2 has been closed
Part 3 we will determine the energy balance in patients with primary autonomic failure
Part 4 we will determine the contribution of the sympathetic nervous system to lipolysisPart 4 has been closed
Subjects selections
For part 1 and 2 we will study six groups of subjects n 40 for each group patients with pure autonomic failure patients with multiple system atrophy healthy normal controls BMI 25 obese controls BMI 30-40 and obese hypertensive BMI 30-40 and lean hypertensive BMI 20-28 A time interval of at least 1 week is required for those subjects who wish to participate in part 1 and part 2 For part 3 we will study two groups of subjects n12 for each group patients with autonomic failure and their age sex-matched sedentary healthy controls For part 4 we will study two groups of subjects n12 for each group healthy normal controls BMI 20-25 obese controls BMI 30-40
Part 2 and 4 have been closed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HL56693 | None | None | None |