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

Obesity Clinical Trial

— omentectomy  

Official title:

PHASE 1 The Effect of the Omentectomy on the Hyperglycemia and the Resistance to the Insulin in Patients With Morbid Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00454597
• Other study ID #: 0910-0459
• Secondary ID: ID :0910-0459
• Status: Completed
• Phase: Phase 0
• First received: March 27, 2007
• Last updated: May 30, 2008
• Start date: February 2007
• Est. completion date: December 2007

Study information

• Verified date: May 2008
• Source: Universidad de Guanajuato
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: National Institute of Public Health, Health Secretariat
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Hyperglycemia
• Obesity
• Obesity, Morbid

Intervention

Procedure:
• omentectomy
surgery omentectomy

Locations

Country	Name	City	State
Mexico	Hospital General Regional de León, Universidad de Guanajuato, Facultad de Medicina de León	Leon	Guanajuato

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Guanajuato

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

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., Omen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		3 months	No
Secondary	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		3 months	No