Effect of the Omentectomy on the Hyperglycemia and the Resistance to the Insulin in Patients With Morbid Obesity - Full Text View

Purpose

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.

Condition	Intervention	Phase
Obesity Diabetes Mellitus Type 2	Procedure: omentectomy	Phase 0

MedlinePlus related topics:

Diabetes Obesity

Drug Information available for:

Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Universidad de Guanajuato:

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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment:	21
Study Start Date:	February 2007
Study Completion Date:	December 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Intervention Details:

surgery omentectomy

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

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454597

Locations


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

Sponsors and Collaborators

Universidad de Guanajuato

Investigators


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

More Information

Publications of Results:

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., Omentectomy Improves Insulin Sensitivity in Skeletal Muscle in vivo. 2005, Abstract Society of University Surgeons. Thorne, A., et al., 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. 26(2): p. 193-9.

Responsible Party:	universidad de guanajuato ( arturo reyes hernandez )
Study ID Numbers:	0910-0459, ID :0910-0459
First Received:	March 27, 2007
Last Updated:	May 30, 2008
ClinicalTrials.gov Identifier:	NCT00454597
Health Authority:	Mexico: National Institute of Public Health, Health Secretariat

Study placed in the following topic categories:

Obesity

Metabolic Diseases

Diabetes Mellitus

Endocrine System Diseases

Obesity, Morbid

Overweight

Insulin

Body Weight

Signs and Symptoms

Hyperglycemia

Diabetes Mellitus, Type 2

Nutrition Disorders

Overnutrition

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on October 22, 2008

Sponsored by:	Universidad de Guanajuato
Information provided by:	Universidad de Guanajuato
ClinicalTrials.gov Identifier:	NCT00454597