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:
University of California, San Diego
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
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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
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 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013