Effect of Weight Loss Surgery on Stem Cells.

NCT04132531 | Completed

• 1 other identifier: PRO_B_001
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity, Morbid; Stem Cells; Cardiovascular Morbidity

Keywords

Stem Cells; Obesity; Cardiovascular Events; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in the frequency of circulating cells with aldehyde dehydrogenase activity.

  Baseline and after surgery, 3-4 months

Secondary Outcomes (1)

• Change in the frequency of circulating cells with aldehyde dehydrogenase activity and cell surface marker expression.

  Baseline and after surgery, 3-4 months

Other Outcomes (1)

• Changes in the concentration of oxidative stress and inflammatory markers

  Baseline and after surgery, 3-4 months

Study Arms (2)

Normal weight control

Individuals who are generally healthy and have a body mass index less than 25 kg/m\^2.

Bariatric Surgery Group

Individuals electing to undergo bariatric surgery (generally with a body mass index between 35 and 40 kg/m\^2 with an additional co-morbidity such as type 2 diabetes, or individuals with a body mass index greater than 40 kg/m\^2) and who are willing to participate for 2 visits, one before and one after surgery. The intervention in this group is bariatric surgery.

Procedure: Bariatric (weight loss) surgery

Interventions

Bariatric (weight loss) surgery PROCEDURE

Surgical intervention for weight reduction, whereby the stomach is resected and the gastrointestinal tract is rerouted in the case of Roux-en-y gastric bypass, or the stomach is only resected in the case of sleeve gastrectomy.

Bariatric Surgery Group

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Community Sample/Residents mainly from the Greater Toronto Area.

You may qualify if:

• Individuals undergoing bariatric surgery
• Must be able to provide two visits, before and after surgery

You may not qualify if:

• Unable to provide written consent
• Unable to provide two visits for blood collection

Sponsors & Collaborators

• Unity Health Toronto: lead
• Humber River Hospital: collaborator
• University of Western Ontario, Canada: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (30)

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Biospecimen

Retention: SAMPLES WITH DNA

Serum was collected and stored.

MeSH Terms

Conditions

Obesity, Morbid; Obesity; Diabetes Mellitus, Type 2

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Subodh Verma, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• David A Hess, PhD

  Robart's Research Institute, London, Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Surgery and Pharmacology & Toxicology

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 18, 2019
• Study Start: May 1, 2018
• Primary Completion: June 25, 2019
• Study Completion: August 13, 2019
• Last Updated: October 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Starting 6 month following publication.

Locations

CA (1)