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

NCT ID: NCT00454597

Last Updated: 2008-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Obesity Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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omentectomy

surgery omentectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Guanajuato

OTHER

Sponsor Role lead

Responsible Party

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universidad de guanajuato

Principal Investigators

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Arturo MD Reyes Hernandez, Surgery

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

León, Guanajuato, Mexico

Site Status

Countries

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Mexico

References

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Thorne A, Lonnqvist F, Apelman J, Hellers G, Arner P. 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 Feb;26(2):193-9. doi: 10.1038/sj.ijo.0801871.

Reference Type RESULT
PMID: 11850750 (View on PubMed)

Other Identifiers

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ID :0910-0459

Identifier Type: -

Identifier Source: secondary_id

0910-0459

Identifier Type: -

Identifier Source: org_study_id