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Characteristics of Dendritic Cells Before and After Gastric Banding

This study has been terminated.
(Terminated due to a lack of recruitment and decision by the PI not to continue.)
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00488930
First received: June 11, 2007
Last updated: July 14, 2011
Last verified: July 2011
  Purpose

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 Intervention
Morbid Obesity
Hyperglycemia
Diabetes Mellitus
Other: Observational

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Characteristics of Dendritic Cells Before and After Gastric Banding

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Measure changes in dendritic cells at baseline, 6 months and 1 year following weight loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: June 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Observational
    data collection ONLY
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All subjects being treated for obesity at this institution

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488930

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

No publications provided

Responsible Party: Santiago Horgan, MD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00488930     History of Changes
Other Study ID Numbers: 070685, Internal Funding, NIH MED 1736
Study First Received: June 11, 2007
Last Updated: July 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Obesity
Hyperglycemia
Diabetes Mellitus Type I
Diabetes Mellitus Type II

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

ClinicalTrials.gov processed this record on November 20, 2014