Back to results

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

Primary Purpose

Obesity, Diabetes Mellitus Type 2

Status

Completed

Phase

Early Phase 1

Locations

Mexico

Study Type

Interventional

Intervention

omentectomy

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Outcomes

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

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

Full Information

NCT ID

NCT00454597

First Posted

March 27, 2007

Last Updated

May 30, 2008

Sponsor

Universidad de Guanajuato

1. Study Identification

Unique Protocol Identification Number

NCT00454597

Brief Title

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

Acronym

omentectomy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

March 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Universidad de Guanajuato

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Diabetes Mellitus Type 2

7. Study Design

Primary Purpose

Prevention

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

omentectomy

Intervention Description

surgery omentectomy

Primary Outcome Measure Information:

Title

Time Frame

3 months

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arturo MD Reyes Hernandez, Surgery

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Leon

State/Province

Guanajuato

ZIP/Postal Code

37320

Country

Mexico

12. IPD Sharing Statement

Citations:

PubMed Identifier

11850750

Citation

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.

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs