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Bariatric Surgery for Morbid Obesity

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ClinicalTrials.gov Identifier: NCT00675558
Recruitment Status : Completed
First Posted : May 9, 2008
Results First Posted : March 11, 2013
Last Update Posted : July 26, 2013
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Paul D. Berk, Columbia University

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Prospective
Conditions Obesity
Morbid Obesity
Interventions Procedure: Initial Surgery
Procedure: Second Bariatric Surgery
Enrollment 50
Recruitment Details Patients referred to several Divisions of the Department of Surgery at New York Presbyterian Hospital.
Pre-assignment Details  
Arm/Group Title Non-Obese (NO) Morbidly Obese (MO) Super-morbidly Obese (SMO)
Hide Arm/Group Description Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery. Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.

Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.

10 subjects of the original 30 subjects enrolled into this group received a second bariatric procedure. The remaining 20 subjects of the original 30 subjects did not continue on to the second phase (initial bariatric surgery) of the study.

Period Title: Surgery
Started 10 10 30
Completed 10 10 30
Not Completed 0 0 0
Period Title: Second Operation
Started 0 [1] 0 [2] 10 [3]
Completed 0 0 10
Not Completed 0 0 0
[1]
No medical reason, and no study-related reason for non-obese pts to have a second procedure.
[2]
No medical reason, and none for the goals of the study, for MO pts to have a second procedure .
[3]
As predicted, only 10 SMO patients medically required a second operation, and thus met study goals.
Arm/Group Title Non-Obese (NO) Morbidly Obese (MO) Super-morbidly Obese (SMO) Total
Hide Arm/Group Description Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery. Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery. Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery. Total of all reporting groups
Overall Number of Baseline Participants 10 10 30 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 30 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
30
 100.0%
50
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 30 participants 50 participants
Female
5
  50.0%
5
  50.0%
16
  53.3%
26
  52.0%
Male
5
  50.0%
5
  50.0%
14
  46.7%
24
  48.0%
1.Primary Outcome
Title Size of Adipocytes
Hide Description The mean diameters of omental adipocytes were measured
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Obese (NO) Morbidly Obese (MO) Super-morbidly Obese (SMO)
Hide Arm/Group Description:
Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
Overall Number of Participants Analyzed 10 10 30
Mean (Standard Deviation)
Unit of Measure: µm
73.4  (16.1) 99.0  (24.0) 103.0  (14.2)
2.Primary Outcome
Title Maximum Reaction Velocity (Vmax) for Facilitated LCFA Uptake
Hide Description The Vmax for facilitated Long Chain Fatty Acids (LCFA) uptake by omental adipocytes was measured.
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Obese (NO) Morbidly Obese (MO) Super-morbidly Obese (SMO)
Hide Arm/Group Description:
Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
Overall Number of Participants Analyzed 10 10 30
Mean (Standard Deviation)
Unit of Measure: pmol/sec
8.3  (1.8) 20.9  (4.1) 68.7  (9.45)
3.Secondary Outcome
Title Maximum Reaction Velocity (Vmax) for Fatty Acid Uptake Relative to Adipocyte Cell Surface Area
Hide Description Fatty acid uptake was expressed relative to adipocyte cell surface area [Vmax’(pmol/sec/µm^2) = Vmax/(cell surface area) X 10^8].
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Obese (NO) Morbidly Obese (MO) Super-morbidly Obese (SMO)
Hide Arm/Group Description:
Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
Overall Number of Participants Analyzed 10 10 30
Mean (Standard Deviation)
Unit of Measure: pmol/sec/μm^2
0.88  (0.39) 1.24  (0.36) 3.21  (1.89)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Non-Obese (NO) Morbidly Obese (MO) Super-morbidly Obese (SMO)
Hide Arm/Group Description Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery. Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery. Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
All-Cause Mortality
Non-Obese (NO) Morbidly Obese (MO) Super-morbidly Obese (SMO)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Non-Obese (NO) Morbidly Obese (MO) Super-morbidly Obese (SMO)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Non-Obese (NO) Morbidly Obese (MO) Super-morbidly Obese (SMO)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Paul D. Berk, MD
Organization: Columbia University Medical Center
Phone: 2120-305-4491
EMail: pb2158@columbia.edu
Layout table for additonal information
Responsible Party: Paul D. Berk, Columbia University
ClinicalTrials.gov Identifier: NCT00675558     History of Changes
Other Study ID Numbers: AAAC0355
R01DK072526 ( U.S. NIH Grant/Contract )
First Submitted: May 7, 2008
First Posted: May 9, 2008
Results First Submitted: December 6, 2012
Results First Posted: March 11, 2013
Last Update Posted: July 26, 2013