Trial Outcomes & Findings for Bariatric Surgery for Morbid Obesity (NCT NCT00675558)
NCT ID: NCT00675558
Last Updated: 2013-07-26
Results Overview
The mean diameters of omental adipocytes were measured
Recruitment status
COMPLETED
Target enrollment
50 participants
Primary outcome timeframe
4 years
Results posted on
2013-07-26
Participant Flow
Patients referred to several Divisions of the Department of Surgery at New York Presbyterian Hospital.
Participant milestones
| Measure |
Non-Obese (NO)
Patients with a BMI \< 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
|
Morbidly Obese (MO)
Patients with a BMI \> 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
|
Super-morbidly Obese (SMO)
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.
|
|---|---|---|---|
|
Surgery
STARTED
|
10
|
10
|
30
|
|
Surgery
COMPLETED
|
10
|
10
|
30
|
|
Surgery
NOT COMPLETED
|
0
|
0
|
0
|
|
Second Operation
STARTED
|
0
|
0
|
10
|
|
Second Operation
COMPLETED
|
0
|
0
|
10
|
|
Second Operation
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bariatric Surgery for Morbid Obesity
Baseline characteristics by cohort
| Measure |
Non-Obese (NO)
n=10 Participants
Non obese patients. Patients with a BMI \< 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
|
Morbidly Obese (MO)
n=10 Participants
Patients with a BMI \> 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
|
Super-morbidly Obese (SMO)
n=30 Participants
Patients with a BMI \> 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
0 • n=5 Participants
|
0 Participants
0 • n=7 Participants
|
0 Participants
0 • n=5 Participants
|
0 Participants
0 • n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
0 • n=5 Participants
|
10 Participants
0 • n=7 Participants
|
30 Participants
0 • n=5 Participants
|
50 Participants
0 • n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
0 • n=5 Participants
|
0 Participants
0 • n=7 Participants
|
0 Participants
0 • n=5 Participants
|
0 Participants
0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 yearsThe mean diameters of omental adipocytes were measured
Outcome measures
| Measure |
Non-Obese (NO)
n=10 Participants
Non obese patients. Patients with a BMI \< 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
|
Morbidly Obese (MO)
n=10 Participants
Patients with a BMI \> 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
|
Super-morbidly Obese (SMO)
n=30 Participants
Patients with a BMI \> 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
|
|---|---|---|---|
|
Size of Adipocytes
|
73.4 µm
Standard Deviation 16.1
|
99.0 µm
Standard Deviation 24.0
|
103.0 µm
Standard Deviation 14.2
|
PRIMARY outcome
Timeframe: 4 yearsThe Vmax for facilitated Long Chain Fatty Acids (LCFA) uptake by omental adipocytes was measured.
Outcome measures
| Measure |
Non-Obese (NO)
n=10 Participants
Non obese patients. Patients with a BMI \< 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
|
Morbidly Obese (MO)
n=10 Participants
Patients with a BMI \> 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
|
Super-morbidly Obese (SMO)
n=30 Participants
Patients with a BMI \> 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
|
|---|---|---|---|
|
Maximum Reaction Velocity (Vmax) for Facilitated LCFA Uptake
|
8.3 pmol/sec
Standard Deviation 1.8
|
20.9 pmol/sec
Standard Deviation 4.1
|
68.7 pmol/sec
Standard Deviation 9.45
|
SECONDARY outcome
Timeframe: 4 yearsFatty acid uptake was expressed relative to adipocyte cell surface area \[Vmax'(pmol/sec/µm\^2) = Vmax/(cell surface area) X 10\^8\].
Outcome measures
| Measure |
Non-Obese (NO)
n=10 Participants
Non obese patients. Patients with a BMI \< 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
|
Morbidly Obese (MO)
n=10 Participants
Patients with a BMI \> 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
|
Super-morbidly Obese (SMO)
n=30 Participants
Patients with a BMI \> 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
|
|---|---|---|---|
|
Maximum Reaction Velocity (Vmax) for Fatty Acid Uptake Relative to Adipocyte Cell Surface Area
|
0.88 pmol/sec/μm^2
Standard Deviation 0.39
|
1.24 pmol/sec/μm^2
Standard Deviation 0.36
|
3.21 pmol/sec/μm^2
Standard Deviation 1.89
|
Adverse Events
Non-Obese (NO)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Morbidly Obese (MO)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Super-morbidly Obese (SMO)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place