Obesity, MorbidNCT03419273
Adipose Tissue Inflammation in Individuals Undergoing Bariatric Surgery
An observational study of Obesity, Morbid and Bariatric Surgery Candidate, run by University of Missouri-Columbia at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid, Bariatric Surgery Candidate
- What is being tested?
- bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 1 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All subject are already scheduled to have bariatric surgery at the University of Missouri-Columbia Department of Surgery.
Who may be able to join
- 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.
Who cannot join
- Women who are perimenopausal. Women who are on Hormone Replacement Therapy.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Obesity, Morbid, Bariatric Surgery Candidate
- Being tested
- bariatric surgery
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bariatric surgeryProcedure or surgery
We are recruiting only those going through bariatric surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
TNFa
TNFa
Measured: measured in the one sample collected at surgery
Il-6
Il-6
Measured: measured in the one sample collected at surgery
macrophage
macrophage
Measured: measured in the one sample collected at surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start1 Jul 2017
- Primary completion31 Mar 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill Kanaley, University of Missouri-Columbia
- Investigators
- Jill Kanaley, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419273
- Sponsor's protocol ID
- Bariatric surgery
- Status last verified
- Oct 2019
- First submitted
- 20 Jan 2018
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32734695
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Tissue Inflammation in Individuals Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03419273
- Acronym / sponsor ID
- Bariatric surgery
- Conditions
- Obesity, Morbid, Bariatric Surgery Candidate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 1 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All subject are already scheduled to have bariatric surgery at the University of Missouri-Columbia Department of Surgery.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Women who are perimenopausal. Women who are on Hormone Replacement Therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bariatric surgeryWe are recruiting only those going through bariatric surgery | Procedure or surgery | – |
Primary outcome
TNFa
Time frame: measured in the one sample collected at surgery
TNFa
Il-6
Time frame: measured in the one sample collected at surgery
Il-6
macrophage
Time frame: measured in the one sample collected at surgery
macrophage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Derived from this study: PubMed 32734695Porter 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Kanaley, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid and Bariatric Surgery Candidate, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TNFa (time frame: measured in the one sample collected at surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03419273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019.