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Effect of the Omentectomy on the Hyperglycemia and the Resistance to the Insulin in Patients With Morbid Obesity (omentectomy)

This study has been completed.
Sponsor:
Information provided by:
Universidad de Guanajuato
ClinicalTrials.gov Identifier:
NCT00454597
First received: March 27, 2007
Last updated: May 30, 2008
Last verified: May 2008
History of Changes
  Purpose

To determine if the omentectomy diminishes hyperglycemia and improves the resistance to the insulin in patients with morbid obesity and propensity to develop to Diabetes Mellitus type 2.


Condition Intervention Phase
Obesity
Diabetes Mellitus Type 2
 Procedure: omentectomy
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: PHASE 1 The Effect of the Omentectomy on the Hyperglycemia and the Resistance to the Insulin in Patients With Morbid Obesity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universidad de Guanajuato:

Primary Outcome Measures:
  • To compare the Blood levels of of glucose, curve of tolerance wing glucose, hemoglobin glycosylated, insulin, triglyceride, cholesterol, HDL, LDL, leptin and Adiponectin before and after the procedure [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the metabolic conditions of the subjects of both groups to the 15 days and the month, 6, 12 and 24 months later to the procedure [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: February 2007
Study Completion Date: December 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: omentectomy
    surgery omentectomy
Detailed Description:

To determine the Blood levels of glucose, curve of tolerance to the glucose, hemoglobin glycosylated, insulin, triglyceride, cholesterol, HDL, LDL, leptin and Adiponectin in patients with Obesity Morbid and that will be put under umbilical surgery and cholecystectomy opened.

To put under them umbilical surgery or Cholecystectomy open with and without omentectomy To compare the Blood levels of of glucose, curve of tolerance wing glucose, hemoglobin glycosylated, insulin, triglyceride, cholesterol, HDL, LDL, leptin and Adiponectin before and after the procedure

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All the patients with Obesity Morbid who suffer of hernia umbilical Chronic Cholecystitis Lithiasic non worsened.
  • Patient with age between the 18 to 55 years of age.
  • Both sorts.
  • Patient with index of corporal mass from 30 to 35.
  • Patient with index waist greater or equal hip of 100cm in men and women greater of 88cm.
  • Patient that has a central glucose of 100 to 125mg.
  • Patient that has a tolerance to the glucose of 140 to 200mg.
  • Patient which they have a result of triglyceride in blood of 300 or greater.
  • Patient that has values of LHD below 40 mg/dl.

Exclusion Criteria:

  • Patient that they have I diagnose already established of Diabetes Mellitus type 2 and in medical treatment.
  • Patient with elevation of hepátic enzymes (more than 50% of the superior limits of normality) and/or creatinin in 1,5 serum > mg/Dl.
  • Patient with Diabetic ketoacidosis history.
  • Uso of oral anticoagulants.
  • Positive Test of pregnancy (Human Chorionic Gonadotropin ) for women.
  • Recurrent Infections and at the time of the study.
  • Umbilical Hernia complicated and strangled or Worsened Chronic Cholecystitis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00454597

Locations
Mexico
Hospital General Regional de León, Universidad de Guanajuato, Facultad de Medicina de León
Leon, Guanajuato, Mexico, 37320
Sponsors and Collaborators
Universidad de Guanajuato
Investigators
Principal Investigator: Arturo MD Reyes Hernandez, Surgery Universidad de Guanajuato, Facultad de Medicina de León, Hospital General Regional de León
  More Information

Publications:
Torquati A, L.R., Abumrad N, Richards, WO., Is Roux-en-Y Gastric Bypass Surgery the Most Effective Treatment for Type 2 Diabetes Mellitus in Morbidly Obese Patients? Journal of Gastrointestinal Surgery, 2005. ( Accepted in press). Hansen, E., et al., Omentectomy Improves Insulin Sensitivity in Skeletal Muscle in vivo. 2005, Abstract Society of University Surgeons. Thorne, A., et al., A pilot study of long-term effects of a novel obesity treatment: omentectomy in connection with adjustable gastric banding. Int J Obes Relat Metab Disord, 2002. 26(2): p. 193-9.

Responsible Party: arturo reyes hernandez, universidad de guanajuato
ClinicalTrials.gov Identifier: NCT00454597     History of Changes
Other Study ID Numbers: 0910-0459, ID :0910-0459
Study First Received: March 27, 2007
Last Updated: May 30, 2008
Health Authority: Mexico: National Institute of Public Health, Health Secretariat

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperglycemia
Obesity
Obesity, Morbid
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013