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OpenTrials
Completed

NCT Number: NCT00434525

Laparoscopic Sleeve Gastrectomy With and Without Omentectomy

* The investigators aim to determine the clinical and metabolic effects of sleeve gastrectomy with or without omentectomy in the treatment of morbid obesity. * The investigators hypothesize that the endocrine suppression of ghrelin (appetite hormone)and resistin (insulin antagonist) provided by sleeve gastrectomy and omentectomy (omentum or intra-abdominal fat removal) will provide clinical and metabolic benefits for morbidly obese patients.

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Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

VA North Texas

Dallas, Texas, 75216, United States

About this study

This is a phase 3 prospective randomized trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Morbidly obese VETERANS ONLY (BMI>35 with comorbidities or BMI>40)
  • Age > 18

Exclusion criteria

  • Pregnancy
  • Uncontrolled medical or psychiatric conditions
  • Previous bariatric procedure

Treatment and study plan

Laparoscopic restrictive procedure

Procedure

Patients will receive laparoscopic sleeve gastrectomy with or without omentectomy

Sleeve gastrectomy

Procedure

Sleeve gastrectomy

Primary outcomes

  1. Weight loss

    Time frame: 5 years

Secondary outcomes

  1. Metabolic outcomes

    Time frame: 5 years

  2. Diabetes resolution

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

North Texas Veterans Healthcare System

Fed

Registry information

Official study title

Metabolic Effects of Laparoscopic Sleeve Gastrectomy With or Without Omentectomy: Prospective Randomized Trial

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 13, 2007
Registry last updated
Dec 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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