Metabolic Syndrome, Morbid Obesity
Conditions
Keywords
Omentectomy, metabolic syndrome, acute phase reactants
Brief summary
The aim of the present study was to evaluate the additional effect of sudden visceral fat reduction by omentectomy on Metabolic Syndrome, acute phase reactants and inflammatory mediators in patients with morbid obesity undergoing Laparoscopic Roux-en-Y Gastric Bypass.
Detailed description
Although weight loss controls Metabolic Syndrome and reduces the level of inflammatory markers in patients with Morbid Obesity, patients may enjoy the benefit achieving metabolic control before significant weight loss occurs.
Interventions
Laparoscopic Roux-en-Y Gastric Bypass was performed according to the following standards: Gastric pouch was constructed using the lesser curvature of the stomach. A 45mm stapler was initially fired horizontally 2 to 3 cm below the gastroesophageal junction and then 2 o 3 additional fires towards the angle of His and against a 32 French intragastric tube completed the vertical transection. Lengths of the biliopancreatic and alimentary limbs were approximately 50, and 150 cm respectively. An antecolic and antegastric gastrojejunostomy, 1.0 to 1.5 cm in size was hand sewn and the jejuno-jejunostomy was completed in a latero-lateral fashion using one fire of 45 mm lineal stapler with hand sewn closure of the common enterotomy.
PROCEDUREOmentectomy
After laparoscopic gastric bypass, the greater omentum was divided in the middle from the free edge to the colonic margin using ultrasonic energy. Attachments between the omentum and the transverse colon were dissected. The omentum was detached from the stomach transecting the vessels between the right gastroepiploic vessels and the greater curvature of the stomach. Once the omentum was freed from the stomach, the duodenum and the lower pole of the spleen, it was extracted from the abdominal cavity in a sterile plastic bag.
Sponsors
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* BMI \> 35 Kg/m2 * Metabolic syndrome diagnosed
Exclusion criteria
* Type 1 diabetes * Uncontrolled type 2 diabetes * Cirrhosis or active hepatitis * Pregnancy * Recent MI or stroke
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Components of Metabolic Syndrome (High-Density Lipoproteins) | Basal | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. |
| Components of Metabolic Syndrome (Glucose) | Basal | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. |
| Components of Metabolic Syndrome (Insulin) | Basal | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. |
| Components of Metabolic Syndrome (Total Cholesterol) | Basal | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. |
| Components of Metabolic Syndrome (Triglycerides) | Basal | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. |
| Components of Metabolic Syndrome (Low-Density Lipoproteins) | Basal | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. |
| Components of Metabolic Syndrome (Body Mass Index) | Basal | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. |
| Components of Metabolic Syndrome (Systolic Blood Pressure) | Basal | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. |
| Components of Metabolic Syndrome (Diastolic Blood Pressure) | Basal | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Phase Reactants and Inflammatory Mediators (Interleukine-6) | Basal | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement |
| Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein) | Basal | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement |
| Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha) | Basal | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. |
| Acute Phase Reactants and Inflammatory Mediators (Adiponectin) | Basal | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. |
| Acute Phase Reactants and Inflammatory Mediators (Leptin) | Basal | Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement. |
Participant flow
Recruitment details
Patients from the obesity clinic were recruited from November 2005 to October 2006
Participants by arm
| Arm | Count |
|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | 12 |
| Roux-en-Y Gastric Bypass Alone | 12 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Roux-en-Y Gastric Bypass Alone | Roux-en-Y Gastric Bypass/Omentectomy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 12 Participants | 24 Participants |
| Age Continuous | 39.8 years STANDARD_DEVIATION 11.1 | 36.8 years STANDARD_DEVIATION 12.9 | 38.3 years STANDARD_DEVIATION 11.9 |
| Region of Enrollment Mexico | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 11 Participants | 9 Participants | 20 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 1 / 12 | 0 / 12 |
Outcome results
Primary
Components of Metabolic Syndrome (Body Mass Index)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 1 month
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Body Mass Index) | 40.1 Kg/m2 | Standard Deviation 3 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Body Mass Index) | 40 Kg/m2 | Standard Deviation 3.9 |
p-value: 0.96t-test, 2 sided
Primary
Components of Metabolic Syndrome (Body Mass Index)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Body Mass Index) | 36.5 Kg/m2 | Standard Deviation 3 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Body Mass Index) | 36.2 Kg/m2 | Standard Deviation 3.8 |
p-value: 0.86t-test, 2 sided
Primary
Components of Metabolic Syndrome (Body Mass Index)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Body Mass Index) | 30.3 Kg/m2 | Standard Deviation 2.5 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Body Mass Index) | 30.7 Kg/m2 | Standard Deviation 3.8 |
p-value: 0.76t-test, 2 sided
Primary
Components of Metabolic Syndrome (Body Mass Index)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: Basal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Body Mass Index) | 44.9 Kg/m2 | Standard Deviation 3.1 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Body Mass Index) | 44.5 Kg/m2 | Standard Deviation 4.3 |
p-value: 0.79t-test, 2 sided
Primary
Components of Metabolic Syndrome (Body Mass Index)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Body Mass Index) | 32.4 Kg/m2 | Standard Deviation 2.9 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Body Mass Index) | 33.2 Kg/m2 | Standard Deviation 3.6 |
p-value: 0.6t-test, 2 sided
Primary
Components of Metabolic Syndrome (Diastolic Blood Pressure)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Diastolic Blood Pressure) | 70 mmHg | Standard Deviation 17.3 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Diastolic Blood Pressure) | 76.7 mmHg | Standard Deviation 15.3 |
p-value: 0.64t-test, 2 sided
Primary
Components of Metabolic Syndrome (Diastolic Blood Pressure)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: Basal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Diastolic Blood Pressure) | 85.5 mmHg | Standard Deviation 7.9 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Diastolic Blood Pressure) | 89 mmHg | Standard Deviation 3.9 |
p-value: 0.2t-test, 2 sided
Primary
Components of Metabolic Syndrome (Diastolic Blood Pressure)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Diastolic Blood Pressure) | 71.7 mmHg | Standard Deviation 4.1 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Diastolic Blood Pressure) | 76.6 mmHg | Standard Deviation 8.7 |
p-value: 0.21t-test, 2 sided
Primary
Components of Metabolic Syndrome (Diastolic Blood Pressure)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Diastolic Blood Pressure) | 70 mmHg | Standard Deviation 6.3 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Diastolic Blood Pressure) | 81.3 mmHg | Standard Deviation 6.4 |
p-value: <0.01t-test, 2 sided
Primary
Components of Metabolic Syndrome (Diastolic Blood Pressure)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Diastolic Blood Pressure) | 74.4 mmHg | Standard Deviation 8.2 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Diastolic Blood Pressure) | 75 mmHg | Standard Deviation 7.1 |
p-value: 0.92t-test, 2 sided
Primary
Components of Metabolic Syndrome (Glucose)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Glucose) | 87.5 mg/dl | Standard Deviation 9.4 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Glucose) | 90.5 mg/dl | Standard Deviation 5.7 |
p-value: 0.39t-test, 2 sided
Primary
Components of Metabolic Syndrome (Glucose)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Glucose) | 88.1 mg/dl | Standard Deviation 9.4 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Glucose) | 89.3 mg/dl | Standard Deviation 7.9 |
p-value: 0.75t-test, 2 sided
Primary
Components of Metabolic Syndrome (Glucose)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: Basal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Glucose) | 99.8 mg/dl | Standard Deviation 8.6 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Glucose) | 105 mg/dl | Standard Deviation 35.6 |
p-value: 0.65t-test, 2 sided
Primary
Components of Metabolic Syndrome (Glucose)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Glucose) | 96.6 mg/dl | Standard Deviation 25.7 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Glucose) | 88.3 mg/dl | Standard Deviation 10.8 |
p-value: 0.33t-test, 2 sided
Primary
Components of Metabolic Syndrome (Glucose)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Glucose) | 87.6 mg/dl | Standard Deviation 4.8 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Glucose) | 85.5 mg/dl | Standard Deviation 7.8 |
p-value: 0.47t-test, 2 sided
Primary
Components of Metabolic Syndrome (High-Density Lipoproteins)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (High-Density Lipoproteins) | 42.9 mg/dl | Standard Deviation 8.7 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (High-Density Lipoproteins) | 45.8 mg/dl | Standard Deviation 12.8 |
p-value: 0.55t-test, 2 sided
Primary
Components of Metabolic Syndrome (High-Density Lipoproteins)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: Basal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (High-Density Lipoproteins) | 38.6 mg/dl | Standard Deviation 9.1 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (High-Density Lipoproteins) | 35.5 mg/dl | Standard Deviation 10.1 |
p-value: 0.44t-test, 2 sided
Primary
Components of Metabolic Syndrome (High-Density Lipoproteins)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (High-Density Lipoproteins) | 31.5 mg/dl | Standard Deviation 9.7 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (High-Density Lipoproteins) | 31.4 mg/dl | Standard Deviation 7.8 |
p-value: 0.97t-test, 2 sided
Primary
Components of Metabolic Syndrome (High-Density Lipoproteins)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (High-Density Lipoproteins) | 38.3 mg/dl | Standard Deviation 12.5 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (High-Density Lipoproteins) | 40.9 mg/dl | Standard Deviation 10.6 |
p-value: 0.61t-test, 2 sided
Primary
Components of Metabolic Syndrome (High-Density Lipoproteins)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (High-Density Lipoproteins) | 34.8 mg/dl | Standard Deviation 10 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (High-Density Lipoproteins) | 35.5 mg/dl | Standard Deviation 8.6 |
p-value: 0.85t-test, 2 sided
Primary
Components of Metabolic Syndrome (Insulin)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Insulin) | 7.3 μU/μL | Standard Deviation 3.6 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Insulin) | 6.6 μU/μL | Standard Deviation 1.5 |
p-value: 0.67t-test, 2 sided
Primary
Components of Metabolic Syndrome (Insulin)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Insulin) | 9.8 μU/μL | Standard Deviation 3 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Insulin) | 10.4 μU/μL | Standard Deviation 4.9 |
p-value: 0.74t-test, 2 sided
Primary
Components of Metabolic Syndrome (Insulin)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: Basal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Insulin) | 21.6 μU/μL | Standard Deviation 9.8 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Insulin) | 22 μU/μL | Standard Deviation 12.4 |
p-value: 0.94t-test, 2 sided
Primary
Components of Metabolic Syndrome (Insulin)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Insulin) | 8.4 μU/μL | Standard Deviation 2.7 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Insulin) | 7.9 μU/μL | Standard Deviation 2.8 |
p-value: 0.72t-test, 2 sided
Primary
Components of Metabolic Syndrome (Low-Density Lipoproteins)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: Basal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Low-Density Lipoproteins) | 106.8 mg/dl | Standard Deviation 32.3 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Low-Density Lipoproteins) | 126.6 mg/dl | Standard Deviation 50 |
p-value: 0.44t-test, 2 sided
Primary
Components of Metabolic Syndrome (Low-Density Lipoproteins)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Low-Density Lipoproteins) | 77.1 mg/dl | Standard Deviation 23.7 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Low-Density Lipoproteins) | 104.1 mg/dl | Standard Deviation 37.6 |
p-value: 0.07t-test, 2 sided
Primary
Components of Metabolic Syndrome (Low-Density Lipoproteins)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Low-Density Lipoproteins) | 91.1 mg/dl | Standard Deviation 21.9 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Low-Density Lipoproteins) | 91 mg/dl | Standard Deviation 32.1 |
p-value: 0.99t-test, 2 sided
Primary
Components of Metabolic Syndrome (Low-Density Lipoproteins)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Low-Density Lipoproteins) | 95 mg/dl | Standard Deviation 18.2 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Low-Density Lipoproteins) | 94.6 mg/dl | Standard Deviation 17.2 |
p-value: 0.96t-test, 2 sided
Primary
Components of Metabolic Syndrome (Low-Density Lipoproteins)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Low-Density Lipoproteins) | 71.4 mg/dl | Standard Deviation 14.7 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Low-Density Lipoproteins) | 104.2 mg/dl | Standard Deviation 43.3 |
p-value: 0.035t-test, 2 sided
Primary
Components of Metabolic Syndrome (Systolic Blood Pressure)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Systolic Blood Pressure) | 116.7 mmHg | Standard Deviation 5.2 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Systolic Blood Pressure) | 124.3 mmHg | Standard Deviation 11.4 |
p-value: 0.15t-test, 2 sided
Primary
Components of Metabolic Syndrome (Systolic Blood Pressure)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: Basal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Systolic Blood Pressure) | 131.8 mmHg | Standard Deviation 9.8 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Systolic Blood Pressure) | 134.6 mmHg | Standard Deviation 6.9 |
p-value: 0.45t-test, 2 sided
Primary
Components of Metabolic Syndrome (Systolic Blood Pressure)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Systolic Blood Pressure) | 115.6 mmHg | Standard Deviation 9 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Systolic Blood Pressure) | 115 mmHg | Standard Deviation 7.1 |
p-value: 0.92t-test, 2 sided
Primary
Components of Metabolic Syndrome (Systolic Blood Pressure)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Systolic Blood Pressure) | 120 mmHg | Standard Deviation 20 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Systolic Blood Pressure) | 116.7 mmHg | Standard Deviation 11.5 |
p-value: 0.81t-test, 2 sided
Primary
Components of Metabolic Syndrome (Systolic Blood Pressure)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Systolic Blood Pressure) | 108.3 mmHg | Standard Deviation 9.8 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Systolic Blood Pressure) | 125 mmHg | Standard Deviation 10.7 |
p-value: 0.01t-test, 2 sided
Primary
Components of Metabolic Syndrome (Total Cholesterol)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Total Cholesterol) | 157.4 mg/dl | Standard Deviation 25.9 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Total Cholesterol) | 166.6 mg/dl | Standard Deviation 25.9 |
p-value: 0.42t-test, 2 sided
Primary
Components of Metabolic Syndrome (Total Cholesterol)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: Basal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Total Cholesterol) | 182.8 mg/dl | Standard Deviation 36.6 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Total Cholesterol) | 192.3 mg/dl | Standard Deviation 55.4 |
p-value: 0.64t-test, 2 sided
Primary
Components of Metabolic Syndrome (Total Cholesterol)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Total Cholesterol) | 125 mg/dl | Standard Deviation 22.5 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Total Cholesterol) | 159.7 mg/dl | Standard Deviation 44.8 |
p-value: 0.038t-test, 2 sided
Primary
Components of Metabolic Syndrome (Total Cholesterol)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Total Cholesterol) | 143.4 mg/dl | Standard Deviation 29.6 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Total Cholesterol) | 167.7 mg/dl | Standard Deviation 44.5 |
p-value: 0.14t-test, 2 sided
Primary
Components of Metabolic Syndrome (Total Cholesterol)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Total Cholesterol) | 155.2 mg/dl | Standard Deviation 27.7 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Total Cholesterol) | 171.9 mg/dl | Standard Deviation 31.6 |
p-value: 0.21t-test, 2 sided
Primary
Components of Metabolic Syndrome (Triglycerides)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Triglycerides) | 99.1 mg/dl | Standard Deviation 34 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Triglycerides) | 118 mg/dl | Standard Deviation 62.2 |
p-value: 0.4t-test, 2 sided
Primary
Components of Metabolic Syndrome (Triglycerides)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: Basal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Triglycerides) | 180.4 mg/dl | Standard Deviation 83.8 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Triglycerides) | 292.4 mg/dl | Standard Deviation 248.3 |
p-value: 0.18t-test, 2 sided
Primary
Components of Metabolic Syndrome (Triglycerides)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Triglycerides) | 108.7 mg/dl | Standard Deviation 40.1 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Triglycerides) | 150.1 mg/dl | Standard Deviation 69.2 |
p-value: 0.1t-test, 2 sided
Primary
Components of Metabolic Syndrome (Triglycerides)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Triglycerides) | 108.6 mg/dl | Standard Deviation 36.7 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Triglycerides) | 140.5 mg/dl | Standard Deviation 62.2 |
p-value: 0.16t-test, 2 sided
Primary
Components of Metabolic Syndrome (Triglycerides)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Components of Metabolic Syndrome (Triglycerides) | 123.1 mg/dl | Standard Deviation 28.3 |
| Roux-en-Y Gastric Bypass Alone | Components of Metabolic Syndrome (Triglycerides) | 159.3 mg/dl | Standard Deviation 79.8 |
p-value: 0.18t-test, 2 sided
Secondary
Acute Phase Reactants and Inflammatory Mediators (Adiponectin)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Acute Phase Reactants and Inflammatory Mediators (Adiponectin) | 18.7 ng/ml | Standard Deviation 6.6 |
| Roux-en-Y Gastric Bypass Alone | Acute Phase Reactants and Inflammatory Mediators (Adiponectin) | 17.7 ng/ml | Standard Deviation 6.5 |
p-value: 0.72t-test, 2 sided
Secondary
Acute Phase Reactants and Inflammatory Mediators (Adiponectin)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: Basal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Acute Phase Reactants and Inflammatory Mediators (Adiponectin) | 10.7 ng/ml | Standard Deviation 5.1 |
| Roux-en-Y Gastric Bypass Alone | Acute Phase Reactants and Inflammatory Mediators (Adiponectin) | 9.5 ng/ml | Standard Deviation 4.8 |
p-value: 0.57t-test, 2 sided
Secondary
Acute Phase Reactants and Inflammatory Mediators (Adiponectin)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Acute Phase Reactants and Inflammatory Mediators (Adiponectin) | 13.9 ng/ml | Standard Deviation 4.3 |
| Roux-en-Y Gastric Bypass Alone | Acute Phase Reactants and Inflammatory Mediators (Adiponectin) | 15.8 ng/ml | Standard Deviation 6.2 |
p-value: 0.43t-test, 2 sided
Secondary
Acute Phase Reactants and Inflammatory Mediators (Adiponectin)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Acute Phase Reactants and Inflammatory Mediators (Adiponectin) | 18.9 ng/ml | Standard Deviation 5.1 |
| Roux-en-Y Gastric Bypass Alone | Acute Phase Reactants and Inflammatory Mediators (Adiponectin) | 16.4 ng/ml | Standard Deviation 10.4 |
p-value: 0.56t-test, 2 sided
Secondary
Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein) | 22.2 μg/mL | Standard Deviation 33.6 |
| Roux-en-Y Gastric Bypass Alone | Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein) | 16.7 μg/mL | Standard Deviation 18.4 |
p-value: 0.64t-test, 2 sided
Secondary
Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein) | 8.9 μg/mL | Standard Deviation 20.1 |
| Roux-en-Y Gastric Bypass Alone | Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein) | 2.8 μg/mL | Standard Deviation 3.1 |
p-value: 0.42t-test, 2 sided
Secondary
Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement
Time frame: Basal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein) | 64.5 μg/mL | Standard Deviation 75.4 |
| Roux-en-Y Gastric Bypass Alone | Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein) | 69.2 μg/mL | Standard Deviation 57.2 |
p-value: 0.87t-test, 2 sided
Secondary
Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein) | 29.6 μg/mL | Standard Deviation 35.7 |
| Roux-en-Y Gastric Bypass Alone | Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein) | 16.5 μg/mL | Standard Deviation 16.4 |
p-value: 0.28t-test, 2 sided
Secondary
Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Acute Phase Reactants and Inflammatory Mediators (Interleukine-6) | 9.9 pg/ml | Standard Deviation 27.8 |
| Roux-en-Y Gastric Bypass Alone | Acute Phase Reactants and Inflammatory Mediators (Interleukine-6) | 6.8 pg/ml | Standard Deviation 12.3 |
p-value: 0.74t-test, 2 sided
Secondary
Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Acute Phase Reactants and Inflammatory Mediators (Interleukine-6) | 4.3 pg/ml | Standard Deviation 5.6 |
| Roux-en-Y Gastric Bypass Alone | Acute Phase Reactants and Inflammatory Mediators (Interleukine-6) | 6.0 pg/ml | Standard Deviation 7.2 |
p-value: 0.57t-test, 2 sided
Secondary
Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement
Time frame: Basal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Acute Phase Reactants and Inflammatory Mediators (Interleukine-6) | 4.8 pg/ml | Standard Deviation 9.5 |
| Roux-en-Y Gastric Bypass Alone | Acute Phase Reactants and Inflammatory Mediators (Interleukine-6) | 8.9 pg/ml | Standard Deviation 16.9 |
p-value: 0.49t-test, 2 sided
Secondary
Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Acute Phase Reactants and Inflammatory Mediators (Interleukine-6) | 17.2 pg/ml | Standard Deviation 36.9 |
| Roux-en-Y Gastric Bypass Alone | Acute Phase Reactants and Inflammatory Mediators (Interleukine-6) | 11.2 pg/ml | Standard Deviation 20.6 |
p-value: 0.65t-test, 2 sided
Secondary
Acute Phase Reactants and Inflammatory Mediators (Leptin)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Acute Phase Reactants and Inflammatory Mediators (Leptin) | 52.4 ng/ml | Standard Deviation 35.5 |
| Roux-en-Y Gastric Bypass Alone | Acute Phase Reactants and Inflammatory Mediators (Leptin) | 65.8 ng/ml | Standard Deviation 57.9 |
p-value: 0.52t-test, 2 sided
Secondary
Acute Phase Reactants and Inflammatory Mediators (Leptin)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Acute Phase Reactants and Inflammatory Mediators (Leptin) | 55 ng/ml | Standard Deviation 39.6 |
| Roux-en-Y Gastric Bypass Alone | Acute Phase Reactants and Inflammatory Mediators (Leptin) | 87 ng/ml | Standard Deviation 57.1 |
p-value: 0.59t-test, 2 sided
Secondary
Acute Phase Reactants and Inflammatory Mediators (Leptin)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: Basal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Acute Phase Reactants and Inflammatory Mediators (Leptin) | 55.4 ng/ml | Standard Deviation 30 |
| Roux-en-Y Gastric Bypass Alone | Acute Phase Reactants and Inflammatory Mediators (Leptin) | 103.6 ng/ml | Standard Deviation 153.1 |
p-value: 0.32t-test, 2 sided
Secondary
Acute Phase Reactants and Inflammatory Mediators (Leptin)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Acute Phase Reactants and Inflammatory Mediators (Leptin) | 39.8 ng/ml | Standard Error 23.6 |
| Roux-en-Y Gastric Bypass Alone | Acute Phase Reactants and Inflammatory Mediators (Leptin) | 44.7 ng/ml | Standard Error 24.4 |
p-value: 0.64t-test, 2 sided
Secondary
Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha) | 5.3 pg/ml | Standard Deviation 2.3 |
| Roux-en-Y Gastric Bypass Alone | Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha) | 4.9 pg/ml | Standard Deviation 1.9 |
p-value: 0.68t-test, 2 sided
Secondary
Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha) | 5.9 pg/ml | Standard Deviation 7.1 |
| Roux-en-Y Gastric Bypass Alone | Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha) | 4.8 pg/ml | Standard Deviation 3.5 |
p-value: 0.71t-test, 2 sided
Secondary
Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Time frame: Basal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha) | 5.2 pg/ml | Standard Deviation 3.3 |
| Roux-en-Y Gastric Bypass Alone | Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha) | 5.7 pg/ml | Standard Deviation 2.7 |
p-value: 0.72t-test, 2 sided
Secondary
Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha) | 2.5 pg/ml | Standard Deviation 2.6 |
| Roux-en-Y Gastric Bypass Alone | Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha) | 4.7 pg/ml | Standard Deviation 2.9 |
p-value: 0.08t-test, 2 sided