Metabolic SyndromeNCT00923260
Omentectomy and Metabolic Syndrome
A study testing Laparoscopic Roux-en-Y Gastric Bypass and Omentectomy in people with Metabolic Syndrome and Morbid Obesity, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Metabolic Syndrome, Morbid Obesity
- What is being tested?
- Laparoscopic Roux-en-Y Gastric Bypass and Omentectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Jul 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI > 35 Kg/m2
- Metabolic syndrome diagnosed
Who cannot join
- Type 1 diabetes
- Uncontrolled type 2 diabetes
- Cirrhosis or active hepatitis
- Pregnancy
- Recent MI or stroke
About this study
Official title: Effect of Omentectomy on Metabolic Syndrome, Acute Phase Reactants & Inflammatory Mediators in Patients Undergoing LRYGBP: A Randomized Trial
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.
Read the 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.
- Conditions
- Metabolic Syndrome, Morbid Obesity
- Being tested
- Laparoscopic Roux-en-Y Gastric Bypass, Omentectomy
- Keywords
- Omentectomy, metabolic syndrome, acute phase reactants
- Medical subject headings
- Metabolic Syndrome, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Roux-en-Y Gastric BypassProcedure or surgery
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.
OmentectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Experimental | Laparoscopic Roux-en-Y Gastric Bypass with omentectomy Receives: Procedure: Laparoscopic Roux-en-Y Gastric Bypass; Procedure: Omentectomy |
| Roux-en-Y Gastric Bypass alone | Active comparator | Not described Receives: Procedure: Laparoscopic Roux-en-Y Gastric Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Basal
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.
Measured: 1 month
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 1 year
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.
Measured: Basal
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.
Measured: 1 month
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 1 year
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.
Measured: Basal
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.
Measured: 1 month
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 1 year
Components of Metabolic Syndrome (Glucose)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Measured: Basal
Components of Metabolic Syndrome (Glucose)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Measured: 1 month
Components of Metabolic Syndrome (Glucose)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Measured: 3 months
Components of Metabolic Syndrome (Glucose)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Measured: 6 months
Components of Metabolic Syndrome (Glucose)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Measured: 1 year
Components of Metabolic Syndrome (Insulin)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Measured: Basal
Components of Metabolic Syndrome (Insulin)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Measured: 3 months
Components of Metabolic Syndrome (Insulin)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Measured: 6 months
Components of Metabolic Syndrome (Insulin)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Measured: 1 year
Components of Metabolic Syndrome (Total Cholesterol)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Measured: Basal
Components of Metabolic Syndrome (Total Cholesterol)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Measured: 1 month
Components of Metabolic Syndrome (Total Cholesterol)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Measured: 3 months
Components of Metabolic Syndrome (Total Cholesterol)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Measured: 6 months
Components of Metabolic Syndrome (Total Cholesterol)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Measured: 1 year
Components of Metabolic Syndrome (Triglycerides)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Measured: Basal
Components of Metabolic Syndrome (Triglycerides)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Measured: 1 month
Components of Metabolic Syndrome (Triglycerides)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Measured: 3 months
Components of Metabolic Syndrome (Triglycerides)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Measured: 6 months
Components of Metabolic Syndrome (Triglycerides)
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Measured: 1 year
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.
Measured: Basal
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.
Measured: 1 month
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 1 year
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.
Measured: Basal
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.
Measured: 1 month
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 1 year
Secondary outcomes (20)
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
Measured: Basal
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 1 year
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
Measured: Basal
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.
Measured: 3 months
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.
Measured: 6 months
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
Measured: 1 year
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.
Measured: Basal
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.
Measured: 3 months
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
Measured: 6 months
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.
Measured: 1 year
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.
Measured: Basal
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 1 year
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.
Measured: Basal
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study startDec 2005
- Primary completionOct 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Investigators
- Miguel F Herrrera, MD, PhD, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00923260
- Sponsor's protocol ID
- INCMNSZ-1486
- Status last verified
- Nov 2009
- First submitted
- 28 Jan 2009
- Last updated
- 7 Dec 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Herrera MF, Pantoja JP, Velazquez-Fernandez D, Cabiedes J, Aguilar-Salinas C, Garcia-Garcia E, Rivas A, Villeda C, Hernandez-Ramirez DF, Davila A, Zarain A. Potential additional effect of omentectomy on metabolic syndrome, acute-phase reactants, and inflammatory mediators in grade III obese patients undergoing laparoscopic Roux-en-Y gastric bypass: a randomized trial. Diabetes Care. 2010 Jul;33(7):1413-8. doi: 10.2337/dc09-1833.
PubMed 20587720
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Omentectomy on Metabolic Syndrome, Acute Phase Reactants & Inflammatory Mediators in Patients Undergoing LRYGBP: A Randomized Trial
- ClinicalTrials.gov ID
- NCT00923260
- Acronym / sponsor ID
- INCMNSZ-1486
- Conditions
- Metabolic Syndrome, Morbid Obesity
- Keywords
- Omentectomy, metabolic syndrome, acute phase reactants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 18 Jun 2009 (estimated)
- Results
- Posted 18 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roux-en-Y Gastric Bypass/Omentectomy | Experimental | Procedure: Laparoscopic Roux-en-Y Gastric Bypass, Procedure: OmentectomyLaparoscopic Roux-en-Y Gastric Bypass with omentectomy |
| Roux-en-Y Gastric Bypass alone | Active comparator | Procedure: Laparoscopic Roux-en-Y Gastric Bypass |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI > 35 Kg/m2
- Metabolic syndrome diagnosed
Key exclusion criteria (5 listed)
- Type 1 diabetes
- Uncontrolled type 2 diabetes
- Cirrhosis or active hepatitis
- Pregnancy
- Recent MI or stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Roux-en-Y Gastric BypassLaparoscopic 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. | Procedure or surgery | Roux-en-Y Gastric Bypass alone, Roux-en-Y Gastric Bypass/Omentectomy |
| OmentectomyAfter 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. | Procedure or surgery | Roux-en-Y Gastric Bypass/Omentectomy |
Primary outcome
Components of Metabolic Syndrome (Body Mass Index)
Time frame: 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)
Time frame: 1 month
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)
Time frame: 3 months
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)
Time frame: 6 months
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)
Time frame: 1 year
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)
Time frame: 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)
Time frame: 1 month
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)
Time frame: 3 months
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)
Time frame: 6 months
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)
Time frame: 1 year
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)
Time frame: 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)
Time frame: 1 month
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)
Time frame: 3 months
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)
Time frame: 6 months
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)
Time frame: 1 year
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (Glucose)
Time frame: Basal
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (Glucose)
Time frame: 1 month
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (Glucose)
Time frame: 3 months
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (Glucose)
Time frame: 6 months
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (Glucose)
Time frame: 1 year
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (Insulin)
Time frame: Basal
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (Insulin)
Time frame: 3 months
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (Insulin)
Time frame: 6 months
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (Insulin)
Time frame: 1 year
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (Total Cholesterol)
Time frame: 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)
Time frame: 1 month
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (Total Cholesterol)
Time frame: 3 months
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (Total Cholesterol)
Time frame: 6 months
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (Total Cholesterol)
Time frame: 1 year
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (Triglycerides)
Time frame: Basal
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (Triglycerides)
Time frame: 1 month
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (Triglycerides)
Time frame: 3 months
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (Triglycerides)
Time frame: 6 months
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (Triglycerides)
Time frame: 1 year
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)
Time frame: 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)
Time frame: 1 month
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)
Time frame: 3 months
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)
Time frame: 6 months
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)
Time frame: 1 year
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (High-Density Lipoproteins)
Time frame: Basal
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (High-Density Lipoproteins)
Time frame: 1 month
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (High-Density Lipoproteins)
Time frame: 3 months
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (High-Density Lipoproteins)
Time frame: 6 months
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (High-Density Lipoproteins)
Time frame: 1 year
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
20 secondary outcomes
Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)
Time frame: Basal
Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)
Time frame: 3 months
Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)
Time frame: 6 months
Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)
Time frame: 1 year
Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)
Time frame: Basal
Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)
Time frame: 3 months
Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)
Time frame: 6 months
Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)
Time frame: 1 year
Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)
Time frame: Basal
Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)
Time frame: 3 months
Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)
Time frame: 6 months
Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)
Time frame: 1 year
Acute Phase Reactants and Inflammatory Mediators (Leptin)
Time frame: Basal
Acute Phase Reactants and Inflammatory Mediators (Leptin)
Time frame: 3 months
Acute Phase Reactants and Inflammatory Mediators (Leptin)
Time frame: 6 months
Acute Phase Reactants and Inflammatory Mediators (Leptin)
Time frame: 1 year
Acute Phase Reactants and Inflammatory Mediators (Adiponectin)
Time frame: Basal
Acute Phase Reactants and Inflammatory Mediators (Adiponectin)
Time frame: 3 months
Acute Phase Reactants and Inflammatory Mediators (Adiponectin)
Time frame: 6 months
Acute Phase Reactants and Inflammatory Mediators (Adiponectin)
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20587720Herrera MF, Pantoja JP, Velazquez-Fernandez D, Cabiedes J, Aguilar-Salinas C, Garcia-Garcia E, Rivas A, Villeda C, Hernandez-Ramirez DF, Davila A, Zarain A. Potential additional effect of omentectomy on metabolic syndrome, acute-phase reactants, and inflammatory mediators in grade III obese patients undergoing laparoscopic Roux-en-Y gastric bypass: a randomized trial. Diabetes Care. 2010 Jul;33(7):1413-8. doi: 10.2337/dc09-1833.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel F Herrrera, MD, PhD principal investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Roux-en-Y Gastric Bypass and Omentectomy in people with Metabolic Syndrome and Morbid Obesity, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Components of Metabolic Syndrome (Body Mass Index) (time frame: Basal). The study lists 44 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00923260, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2009; AzTrials last refreshed its copy on 6 Nov 2026.