Adipose Tissue Inflammation in Individuals Undergoing Bariatric Surgery

Bariatric Surgery Candidate Clinical Trial

Official title:

Adipose Tissue Inflammation in Individuals Undergoing Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03419273
• Other study ID #: Bariatric surgery
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: October 2019
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A growing body of work done over the past few decades has established that adipose tissue as an active endocrine organ which secretes a wide range of metabolic and immunological factors collectively called "adipokines (1)." Importantly, these secreted factors enter into the circulation and have paracrine and autocrine actions, which profoundly impact systemic metabolism (e.g., insulin sensitivity). Additionally, in animals, loss of ovarian hormone production via ovariectomy (similar to menopause in humans) leads to increases in both in adipose tissue mass and in adipose tissue inflammation (2) making this tissue less healthy than that from premenopausal animals. To date, no studies have investigated the effect of menopause on abdominal fat in overweight individuals. Knowing if adipose tissue-specific changes occur with menopause may potentially lead to recommendations or therapeutics to improve women's health post menopause.

Description:

Subjects will just have to agree to having a small amount of adipose tissue being removed during the bariatric surgery. The investigators will also collect a blood sample at that time. There will be no other visits for the subject.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 1, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Women who are premenopausal or who are postmenopausal and have been for at least one year.

Males will be recruited to age match female subjects. All subject are already scheduled to have bariatric surgery at the University of Missouri-Columbia Department of Surgery.

Exclusion Criteria:

• Women who are perimenopausal. Women who are on Hormone Replacement Therapy.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Inflammation
• Obesity, Morbid

Intervention

Procedure:
• bariatric surgery
We are recruiting only those going through bariatric surgery

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TNFa	TNFa	measured in the one sample collected at surgery
Primary	Il-6	Il-6	measured in the one sample collected at surgery
Primary	macrophage	macrophage	measured in the one sample collected at surgery