Characteristics of Dendritic Cells Before and After Gastric Banding

NCT00488930 | Terminated

• 3 other identifiers: 070685Internal FundingNIH MED 1736
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity; Hyperglycemia; Diabetes Mellitus

Keywords

Obesity; Hyperglycemia; Diabetes Mellitus Type I; Diabetes Mellitus Type II

Outcome Measures

Primary Outcomes (1)

• Measure changes in dendritic cells at baseline, 6 months and 1 year following weight loss

  1 year

Interventions

Observational OTHER

data collection ONLY

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All subjects being treated for obesity at this institution

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Medical Center

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Obesity, Morbid; Hyperglycemia; Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Santiago Horgan, MD

  UCSD

  PRINCIPAL INVESTIGATOR

• Jerrold M Olefsky, MD

  UCSD

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: June 11, 2007
• First Posted: June 20, 2007
• Study Start: June 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

US (1)