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Completed

NCT Number: NCT00454597

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Hospital General Regional de León, Universidad de Guanajuato, Facultad de Medicina de León

León, Guanajuato, 37320, Mexico

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Omentectomy

Procedure

surgery omentectomy

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Universidad de Guanajuato

Other

Registry information

Official study title

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

Acronym: omentectomy

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Apr 2, 2007
Registry last updated
Jun 4, 2008

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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