Obesity, Morbid Clinical Trial
Official title:
Impact of Bariatric Surgery on Circulating Inflammatory and Pro-vascular Progenitor Cell Populations.
NCT number | NCT04132531 |
Other study ID # | PRO_B_001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2018 |
Est. completion date | August 13, 2019 |
Verified date | October 2019 |
Source | St. Michael's Hospital, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Obesity and diabetes are linked to increased risk for health problems such as heart attack,
stroke, and death. At the cellular level, obesity and diabetes increase levels of harmful
inflammatory cells (M1 macrophages) and decreases levels of protective stem cells
(circulating progenitor cells) in the blood.
Bariatric (weight loss) surgery is an effective treatment that leads to significant weight
loss and improved health in patients with obesity. However, it is unknown if weight loss
surgery also replenishes healthy stem cells and decreases inflammatory cells in the body.
Therefore, the purpose of this research study is to compare levels of these stem and
inflammatory cells before and after bariatric surgery, and to compare to a control group of
healthy normal weight participants.
The investigators anticipate that inflammatory cell levels will be reduced and stem cell
levels and function will be restored after bariatric surgery, similar to levels of healthy
normal weight individuals.
Status | Completed |
Enrollment | 38 |
Est. completion date | August 13, 2019 |
Est. primary completion date | June 25, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Individuals undergoing bariatric surgery - Must be able to provide two visits, before and after surgery Exclusion Criteria: - Unable to provide written consent - Unable to provide two visits for blood collection |
Country | Name | City | State |
---|---|---|---|
Canada | St. Michael's Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
St. Michael's Hospital, Toronto | Humber River Hospital, University of Western Ontario, Canada |
Canada,
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* Note: There are 29 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes in the concentration of oxidative stress and inflammatory markers | Baseline and after surgery, 3-4 months | ||
Primary | Change in the frequency of circulating cells with aldehyde dehydrogenase activity. | Baseline and after surgery, 3-4 months | ||
Secondary | Change in the frequency of circulating cells with aldehyde dehydrogenase activity and cell surface marker expression. | Baseline and after surgery, 3-4 months |
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