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Deep Brain Stimulation Effects on Weight Change and Metabolic Rate

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ClinicalTrials.gov Identifier: NCT01933113
Recruitment Status : Completed
First Posted : September 2, 2013
Results First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Donald M. Whiting, MD, Allegheny Singer Research Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Obesity
Intervention Device: Deep Brain Stimulation of the Lateral Hypothalamic Area
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Arm
Hide Arm/Group Description

DBS of the LHA

Deep Brain Stimulation of the Lateral Hypothalamic Area

Period Title: Overall Study
Started 3
Completed 2
Not Completed 1
Reason Not Completed
Fractured nonfunctioning lead.             1
Arm/Group Title Single Arm
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DBS of the LHA

Deep Brain Stimulation of the Lateral Hypothalamic Area

Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
2
  66.7%
Male
1
  33.3%
[1]
Measure Analysis Population Description: One subject was withdrawn due to a lead breakage and medical instability pertaining to an unrelated abdominal infection.
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
3
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
BMI   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
2
 100.0%
[1]
Measure Description: Chronic obesity as defined as a BMI over 40
[2]
Measure Analysis Population Description: One subject was withdrawn due to lead fracture and unrelated abdominal infection leaving 2 evaluable subjects
1.Primary Outcome
Title Change in Metabolic Rate
Hide Description Metabolic rate of subjects will be measured while at Pennington Biomedical Research Center. Percentage of change in these parameters will be measured.
Time Frame One week of testing for each subject.
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm
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DBS of the LHA

Deep Brain Stimulation of the Lateral Hypothalamic Area

Overall Number of Participants Analyzed 2
Median (Standard Deviation)
Unit of Measure: percentage of increase in REM and SEE
Sleep Energy Expenditure (SEE) 7.6  (3.9598)
Resting Metabolic Rate (RMR) 18  (2.8284)
Time Frame Subjects were followed for a total of one week
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm
Hide Arm/Group Description Deep Brain Stimulation (DBS) of the Lateral Hypothalamic Area (LHA)
All-Cause Mortality
Single Arm
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Single Arm
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Arm
Affected / at Risk (%)
Total   0/3 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Donald Whiting, MD
Organization: Allegheny Health Network
Phone: 412-359-6200
Responsible Party: Donald M. Whiting, MD, Allegheny Singer Research Institute
ClinicalTrials.gov Identifier: NCT01933113     History of Changes
Other Study ID Numbers: DBS 5583
First Submitted: August 23, 2013
First Posted: September 2, 2013
Results First Submitted: October 10, 2017
Results First Posted: January 8, 2019
Last Update Posted: January 8, 2019