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Completed

NCT Number: NCT00923260

Omentectomy and Metabolic Syndrome

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.

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Key information

Conditions

Metabolic Syndrome Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Morbid Obesity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic Roux-en-Y Gastric Bypass

Procedure

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.

Omentectomy

Procedure

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. 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.

  42. 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.

  43. 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.

  44. 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.

Secondary outcomes

  1. Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)

    Time frame: Basal

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

  2. Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)

    Time frame: 3 months

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

  3. Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)

    Time frame: 6 months

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

  4. Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)

    Time frame: 1 year

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

  5. Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)

    Time frame: Basal

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

  6. Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)

    Time frame: 3 months

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

  7. Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)

    Time frame: 6 months

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

  8. Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)

    Time frame: 1 year

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

  9. Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)

    Time frame: Basal

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

  10. Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)

    Time frame: 3 months

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

  11. Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)

    Time frame: 6 months

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

  12. Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)

    Time frame: 1 year

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

  13. Acute Phase Reactants and Inflammatory Mediators (Leptin)

    Time frame: Basal

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

  14. Acute Phase Reactants and Inflammatory Mediators (Leptin)

    Time frame: 3 months

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

  15. Acute Phase Reactants and Inflammatory Mediators (Leptin)

    Time frame: 6 months

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

  16. Acute Phase Reactants and Inflammatory Mediators (Leptin)

    Time frame: 1 year

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

  17. Acute Phase Reactants and Inflammatory Mediators (Adiponectin)

    Time frame: Basal

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

  18. Acute Phase Reactants and Inflammatory Mediators (Adiponectin)

    Time frame: 3 months

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

  19. Acute Phase Reactants and Inflammatory Mediators (Adiponectin)

    Time frame: 6 months

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

  20. Acute Phase Reactants and Inflammatory Mediators (Adiponectin)

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Registry information

Official study title

Effect of Omentectomy on Metabolic Syndrome, Acute Phase Reactants & Inflammatory Mediators in Patients Undergoing LRYGBP: A Randomized Trial

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Jun 18, 2009
Registry last updated
Dec 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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