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

NCT00454597 | Completed Early Phase 1 DMC

• 2 other identifiers: 0910-0459ID :0910-0459
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Diabetes Mellitus Type 2

Outcome Measures

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

  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

  3 months

Interventions

omentectomy PROCEDURE

surgery omentectomy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Guanajuato: lead

Study Sites (1)

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

León, Guanajuato, 37320, Mexico

Location

Related Publications (1)

• 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.

  PMID: 11850750 RESULT

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Arturo MD Reyes Hernandez, Surgery

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 27, 2007
• First Posted: April 2, 2007
• Study Start: February 1, 2007
• Primary Completion: March 1, 2007
• Study Completion: December 1, 2007
• Last Updated: June 4, 2008

Record last verified: 2008-05

Locations

ME (1)