NCT03419273

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

October 3, 2019

Status Verified

October 1, 2019

Enrollment Period

1.7 years

First QC Date

January 20, 2018

Last Update Submit

October 1, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • TNFa

    TNFa

    measured in the one sample collected at surgery

  • Il-6

    Il-6

    measured in the one sample collected at surgery

  • macrophage

    macrophage

    measured in the one sample collected at surgery

Interventions

We are recruiting only those going through bariatric surgery

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All subject are already scheduled to have bariatric surgery at the University of Missouri-Columbia Department of Surgery.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

Location

Related Publications (1)

  • Porter JW, Barnas JL, Welly R, Spencer N, Pitt J, Vieira-Potter VJ, Kanaley JA. Age, Sex, and Depot-Specific Differences in Adipose-Tissue Estrogen Receptors in Individuals with Obesity. Obesity (Silver Spring). 2020 Sep;28(9):1698-1707. doi: 10.1002/oby.22888. Epub 2020 Jul 31.

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Jill Kanaley, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 20, 2018

First Posted

February 1, 2018

Study Start

July 1, 2017

Primary Completion

March 31, 2019

Study Completion

July 1, 2019

Last Updated

October 3, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations