Trial Outcomes & Findings for Omentectomy and Metabolic Syndrome (NCT NCT00923260)

NCT ID: NCT00923260

Last Updated: 2009-12-07

Results Overview

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: Basal
• Results posted on: 2009-12-07

Participant Flow

Patients from the obesity clinic were recruited from November 2005 to October 2006

Participant milestones

Measure	Roux-en-Y Gastric Bypass/Omentectomy	Roux-en-Y Gastric Bypass Alone
Overall Study STARTED	12	12
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Roux-en-Y Gastric Bypass/Omentectomy	Roux-en-Y Gastric Bypass Alone
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Omentectomy and Metabolic Syndrome

Baseline characteristics by cohort

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=12 Participants	Roux-en-Y Gastric Bypass Alone n=12 Participants	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	36.8 years STANDARD_DEVIATION 12.9 • n=5 Participants	39.8 years STANDARD_DEVIATION 11.1 • n=7 Participants	38.3 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment Mexico	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Basal

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Body Mass Index)	44.9 Kg/m2 Standard Deviation 3.1	44.5 Kg/m2 Standard Deviation 4.3

PRIMARY outcome

Timeframe: 1 month

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Body Mass Index)	40.1 Kg/m2 Standard Deviation 3.0	40 Kg/m2 Standard Deviation 3.9

PRIMARY outcome

Timeframe: 3 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Body Mass Index)	36.5 Kg/m2 Standard Deviation 3.0	36.2 Kg/m2 Standard Deviation 3.8

PRIMARY outcome

Timeframe: 6 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Body Mass Index)	32.4 Kg/m2 Standard Deviation 2.9	33.2 Kg/m2 Standard Deviation 3.6

PRIMARY outcome

Timeframe: 1 year

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Body Mass Index)	30.3 Kg/m2 Standard Deviation 2.5	30.7 Kg/m2 Standard Deviation 3.8

PRIMARY outcome

Timeframe: Basal

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Systolic Blood Pressure)	131.8 mmHg Standard Deviation 9.8	134.6 mmHg Standard Deviation 6.9

PRIMARY outcome

Timeframe: 1 month

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Systolic Blood Pressure)	120 mmHg Standard Deviation 20	116.7 mmHg Standard Deviation 11.5

PRIMARY outcome

Timeframe: 3 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Systolic Blood Pressure)	115.6 mmHg Standard Deviation 9.0	115 mmHg Standard Deviation 7.1

PRIMARY outcome

Timeframe: 6 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Systolic Blood Pressure)	108.3 mmHg Standard Deviation 9.8	125 mmHg Standard Deviation 10.7

PRIMARY outcome

Timeframe: 1 year

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Systolic Blood Pressure)	116.7 mmHg Standard Deviation 5.2	124.3 mmHg Standard Deviation 11.4

PRIMARY outcome

Timeframe: Basal

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Diastolic Blood Pressure)	85.5 mmHg Standard Deviation 7.9	89 mmHg Standard Deviation 3.9

PRIMARY outcome

Timeframe: 1 month

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Diastolic Blood Pressure)	70 mmHg Standard Deviation 17.3	76.7 mmHg Standard Deviation 15.3

PRIMARY outcome

Timeframe: 3 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Diastolic Blood Pressure)	74.4 mmHg Standard Deviation 8.2	75 mmHg Standard Deviation 7.1

PRIMARY outcome

Timeframe: 6 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Diastolic Blood Pressure)	70 mmHg Standard Deviation 6.3	81.3 mmHg Standard Deviation 6.4

PRIMARY outcome

Timeframe: 1 year

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Diastolic Blood Pressure)	71.7 mmHg Standard Deviation 4.1	76.6 mmHg Standard Deviation 8.7

PRIMARY outcome

Timeframe: Basal

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Glucose)	99.8 mg/dl Standard Deviation 8.6	105 mg/dl Standard Deviation 35.6

PRIMARY outcome

Timeframe: 1 month

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Glucose)	96.6 mg/dl Standard Deviation 25.7	88.3 mg/dl Standard Deviation 10.8

PRIMARY outcome

Timeframe: 3 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Glucose)	87.5 mg/dl Standard Deviation 9.4	90.5 mg/dl Standard Deviation 5.7

PRIMARY outcome

Timeframe: 6 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Glucose)	87.6 mg/dl Standard Deviation 4.8	85.5 mg/dl Standard Deviation 7.8

PRIMARY outcome

Timeframe: 1 year

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Glucose)	88.1 mg/dl Standard Deviation 9.4	89.3 mg/dl Standard Deviation 7.9

PRIMARY outcome

Timeframe: Basal

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Insulin)	21.6 μU/μL Standard Deviation 9.8	22 μU/μL Standard Deviation 12.4

PRIMARY outcome

Timeframe: 3 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Insulin)	9.8 μU/μL Standard Deviation 3.0	10.4 μU/μL Standard Deviation 4.9

PRIMARY outcome

Timeframe: 6 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Insulin)	8.4 μU/μL Standard Deviation 2.7	7.9 μU/μL Standard Deviation 2.8

PRIMARY outcome

Timeframe: 1 year

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Insulin)	7.3 μU/μL Standard Deviation 3.6	6.6 μU/μL Standard Deviation 1.5

PRIMARY outcome

Timeframe: Basal

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Total Cholesterol)	182.8 mg/dl Standard Deviation 36.6	192.3 mg/dl Standard Deviation 55.4

PRIMARY outcome

Timeframe: 1 month

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Total Cholesterol)	125 mg/dl Standard Deviation 22.5	159.7 mg/dl Standard Deviation 44.8

PRIMARY outcome

Timeframe: 3 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Total Cholesterol)	143.4 mg/dl Standard Deviation 29.6	167.7 mg/dl Standard Deviation 44.5

PRIMARY outcome

Timeframe: 6 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Total Cholesterol)	155.2 mg/dl Standard Deviation 27.7	171.9 mg/dl Standard Deviation 31.6

PRIMARY outcome

Timeframe: 1 year

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Total Cholesterol)	157.4 mg/dl Standard Deviation 25.9	166.6 mg/dl Standard Deviation 25.9

PRIMARY outcome

Timeframe: Basal

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Triglycerides)	180.4 mg/dl Standard Deviation 83.8	292.4 mg/dl Standard Deviation 248.3

PRIMARY outcome

Timeframe: 1 month

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Triglycerides)	108.7 mg/dl Standard Deviation 40.1	150.1 mg/dl Standard Deviation 69.2

PRIMARY outcome

Timeframe: 3 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Triglycerides)	108.6 mg/dl Standard Deviation 36.7	140.5 mg/dl Standard Deviation 62.2

PRIMARY outcome

Timeframe: 6 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Triglycerides)	123.1 mg/dl Standard Deviation 28.3	159.3 mg/dl Standard Deviation 79.8

PRIMARY outcome

Timeframe: 1 year

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Triglycerides)	99.1 mg/dl Standard Deviation 34	118 mg/dl Standard Deviation 62.2

PRIMARY outcome

Timeframe: Basal

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Low-Density Lipoproteins)	106.8 mg/dl Standard Deviation 32.3	126.6 mg/dl Standard Deviation 50

PRIMARY outcome

Timeframe: 1 month

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Low-Density Lipoproteins)	71.4 mg/dl Standard Deviation 14.7	104.2 mg/dl Standard Deviation 43.3

PRIMARY outcome

Timeframe: 3 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Low-Density Lipoproteins)	77.1 mg/dl Standard Deviation 23.7	104.1 mg/dl Standard Deviation 37.6

PRIMARY outcome

Timeframe: 6 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Low-Density Lipoproteins)	91.1 mg/dl Standard Deviation 21.9	91 mg/dl Standard Deviation 32.1

PRIMARY outcome

Timeframe: 1 year

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (Low-Density Lipoproteins)	95 mg/dl Standard Deviation 18.2	94.6 mg/dl Standard Deviation 17.2

PRIMARY outcome

Timeframe: Basal

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (High-Density Lipoproteins)	38.6 mg/dl Standard Deviation 9.1	35.5 mg/dl Standard Deviation 10.1

PRIMARY outcome

Timeframe: 1 month

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (High-Density Lipoproteins)	31.5 mg/dl Standard Deviation 9.7	31.4 mg/dl Standard Deviation 7.8

PRIMARY outcome

Timeframe: 3 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (High-Density Lipoproteins)	34.8 mg/dl Standard Deviation 10	35.5 mg/dl Standard Deviation 8.6

PRIMARY outcome

Timeframe: 6 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (High-Density Lipoproteins)	38.3 mg/dl Standard Deviation 12.5	40.9 mg/dl Standard Deviation 10.6

PRIMARY outcome

Timeframe: 1 year

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Components of Metabolic Syndrome (High-Density Lipoproteins)	42.9 mg/dl Standard Deviation 8.7	45.8 mg/dl Standard Deviation 12.8

SECONDARY outcome

Timeframe: Basal

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)	4.8 pg/ml Standard Deviation 9.5	8.9 pg/ml Standard Deviation 16.9

SECONDARY outcome

Timeframe: 3 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)	17.2 pg/ml Standard Deviation 36.9	11.2 pg/ml Standard Deviation 20.6

SECONDARY outcome

Timeframe: 6 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)	9.9 pg/ml Standard Deviation 27.8	6.8 pg/ml Standard Deviation 12.3

SECONDARY outcome

Timeframe: 1 year

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)	4.3 pg/ml Standard Deviation 5.6	6.0 pg/ml Standard Deviation 7.2

SECONDARY outcome

Timeframe: Basal

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)	64.5 μg/mL Standard Deviation 75.4	69.2 μg/mL Standard Deviation 57.2

SECONDARY outcome

Timeframe: 3 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)	29.6 μg/mL Standard Deviation 35.7	16.5 μg/mL Standard Deviation 16.4

SECONDARY outcome

Timeframe: 6 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)	22.2 μg/mL Standard Deviation 33.6	16.7 μg/mL Standard Deviation 18.4

SECONDARY outcome

Timeframe: 1 year

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)	8.9 μg/mL Standard Deviation 20.1	2.8 μg/mL Standard Deviation 3.1

SECONDARY outcome

Timeframe: Basal

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)	5.2 pg/ml Standard Deviation 3.3	5.7 pg/ml Standard Deviation 2.7

SECONDARY outcome

Timeframe: 3 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)	5.3 pg/ml Standard Deviation 2.3	4.9 pg/ml Standard Deviation 1.9

SECONDARY outcome

Timeframe: 6 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)	2.5 pg/ml Standard Deviation 2.6	4.7 pg/ml Standard Deviation 2.9

SECONDARY outcome

Timeframe: 1 year

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)	5.9 pg/ml Standard Deviation 7.1	4.8 pg/ml Standard Deviation 3.5

SECONDARY outcome

Timeframe: Basal

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Acute Phase Reactants and Inflammatory Mediators (Leptin)	55.4 ng/ml Standard Deviation 30	103.6 ng/ml Standard Deviation 153.1

SECONDARY outcome

Timeframe: 3 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Acute Phase Reactants and Inflammatory Mediators (Leptin)	39.8 ng/ml Standard Error 23.6	44.7 ng/ml Standard Error 24.4

SECONDARY outcome

Timeframe: 6 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Acute Phase Reactants and Inflammatory Mediators (Leptin)	52.4 ng/ml Standard Deviation 35.5	65.8 ng/ml Standard Deviation 57.9

SECONDARY outcome

Timeframe: 1 year

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Acute Phase Reactants and Inflammatory Mediators (Leptin)	55 ng/ml Standard Deviation 39.6	87 ng/ml Standard Deviation 57.1

SECONDARY outcome

Timeframe: Basal

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Acute Phase Reactants and Inflammatory Mediators (Adiponectin)	10.7 ng/ml Standard Deviation 5.1	9.5 ng/ml Standard Deviation 4.8

SECONDARY outcome

Timeframe: 3 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Acute Phase Reactants and Inflammatory Mediators (Adiponectin)	13.9 ng/ml Standard Deviation 4.3	15.8 ng/ml Standard Deviation 6.2

SECONDARY outcome

Timeframe: 6 months

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Acute Phase Reactants and Inflammatory Mediators (Adiponectin)	18.7 ng/ml Standard Deviation 6.6	17.7 ng/ml Standard Deviation 6.5

SECONDARY outcome

Timeframe: 1 year

Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Outcome measures

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=11 Participants	Roux-en-Y Gastric Bypass Alone n=11 Participants
Acute Phase Reactants and Inflammatory Mediators (Adiponectin)	18.9 ng/ml Standard Deviation 5.1	16.4 ng/ml Standard Deviation 10.4

Adverse Events

Roux-en-Y Gastric Bypass/Omentectomy

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Roux-en-Y Gastric Bypass Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Roux-en-Y Gastric Bypass/Omentectomy n=12 participants at risk	Roux-en-Y Gastric Bypass Alone n=12 participants at risk
Surgical and medical procedures Pancreatic Fistula	8.3% 1/12 • Number of events 1	0.00% 0/12

Other adverse events

Adverse event data not reported

Additional Information

Dr. Miguel F Herrera

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Phone: (+52) 55 54870208

Email: miguelfherrera@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place