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OpenTrials
Completed

NCT Number: NCT03419273

Adipose Tissue Inflammation in Individuals Undergoing Bariatric Surgery

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.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Missouri

Columbia, Missouri, 65211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bariatric surgery

Procedure

We are recruiting only those going through bariatric surgery

Primary outcomes

  1. TNFa

    Time frame: measured in the one sample collected at surgery

    TNFa

  2. Il-6

    Time frame: measured in the one sample collected at surgery

    Il-6

  3. macrophage

    Time frame: measured in the one sample collected at surgery

    macrophage

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 1, 2018
Registry last updated
Oct 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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