Characteristics of Dendritic Cells Before and After Gastric Banding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00488930
Recruitment Status : Terminated (Terminated due to a lack of recruitment and decision by the PI not to continue.)
First Posted : June 20, 2007
Last Update Posted : October 26, 2016
Information provided by (Responsible Party):
Santiago Horgan, University of California, San Diego

Brief Summary:

A research study to find out more about a specific white blood cell called a dendritic cell. These cells are found in a layer of fat in the body called the omentum. The omentum is a layer of fat that covers the bowels (intestines) and protects them.

The purpose of this study is to allow us to compare dendritic cells in normal weight individuals to the dendritic cells of people who are extremely overweight. These cells will be collected from the omentum, the layer of fat that covers and protects the bowels (intestines), from the mesentery, which is another layer of fat that surrounds the intestines directly, and from the subcutaneous tissue, which is the layer of fat just under the skin.

Condition or disease Intervention/treatment
Morbid Obesity Hyperglycemia Diabetes Mellitus Other: Observational

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Characteristics of Dendritic Cells Before and After Gastric Banding
Study Start Date : June 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Intervention Details:
    Other: Observational
    data collection ONLY

Primary Outcome Measures :
  1. Measure changes in dendritic cells at baseline, 6 months and 1 year following weight loss [ Time Frame: 1 year ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All subjects being treated for obesity at this institution

Inclusion Criteria:

  • For gastric banding subjects to qualify for study inclusion, subjects have to have a BMI ranging from 33-40. Currently a BMI of 33 is our lower level of acceptable for bypass. Subjects with a BMI>40 will be excluded because their fat cells are very large and therefore fragile and unsuitable for research use.

Control Group:

  • All adult subjects 18 years or greater being seen in the minimally invasive surgery clinic for elective laparoscopic surgery will also be screened.
  • These will be subjects who are non-obese (BMI<30) and undergoing laparoscopic surgery for a different indication such as hernia repair or cholecystectomy. These will be patients who are undergoing elective procedures to minimize the impact an acute inflamed abdomen may have on the fat cells.

Exclusion Criteria:

  • Women who are pregnant or planning to become pregnant will be excluded from this study. Gastric banding cannot not be performed on pregnant women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00488930

United States, California
UCSD Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Principal Investigator: Santiago Horgan, MD UCSD
Study Director: Jerrold M Olefsky, MD UCSD

Responsible Party: Santiago Horgan, Professor of Surgery, University of California, San Diego Identifier: NCT00488930     History of Changes
Other Study ID Numbers: 070685
Internal Funding
NIH MED 1736
First Posted: June 20, 2007    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by Santiago Horgan, University of California, San Diego:
Diabetes Mellitus Type I
Diabetes Mellitus Type II

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity, Morbid
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nutrition Disorders
Body Weight
Signs and Symptoms