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

May 30, 2008 updated by: Universidad de Guanajuato

PHASE 1 The 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Guanajuato
      • Leon, Guanajuato, Mexico, 37320
        • Hospital General Regional de León, Universidad de Guanajuato, Facultad de Medicina de León

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Guanajuato

Investigators

  • Principal Investigator: Arturo MD Reyes Hernandez, Surgery, Universidad de Guanajuato, Facultad de Medicina de León, Hospital General Regional de León

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

March 27, 2007

First Submitted That Met QC Criteria

March 30, 2007

First Posted (Estimate)

April 2, 2007

Study Record Updates

Last Update Posted (Estimate)

June 4, 2008

Last Update Submitted That Met QC Criteria

May 30, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0910-0459
  • ID :0910-0459

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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