DNA Methylation and Vascular Function
2 other identifiers
interventional
80
1 country
1
Brief Summary
The main objective is to examine DNA hypomethylation as an underlying mechanism for the increased production of inflammatory cytokines and the impaired vascular function in obese individuals and as a potential target for nonpharmacological preventive/therapeutic interventions such as aerobic exercise.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Oct 2019
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2018
CompletedFirst Posted
Study publicly available on registry
May 17, 2018
CompletedStudy Start
First participant enrolled
October 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
September 15, 2025
September 1, 2025
6.7 years
May 3, 2018
September 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
DNA methylation status of adipocytokines in obese individuals
DNA methylation of 20 preselected adipocytokines using "Amplicon sequencing-based methylation profiling" will be measured in fat tissue collected from obese individuals who are scheduled for bariatric surgery before and after 12 weeks of aerobic exercise training.
Month 24-30
Secondary Outcomes (2)
Vascular health biomarkers in obese individuals before and after exercise training
Month 24-30
Flow induced dilation
Month 1-20
Study Arms (2)
Exercising
ACTIVE COMPARATOR12 weeks of aerobic exercise training
Non-exercising
NO INTERVENTIONstandard of care
Interventions
Eligibility Criteria
You may qualify if:
- BMI ≥ 35 kg/m2
- Between ages 18-50 years
- Not pregnant
- Approved for a bariatric surgery
You may not qualify if:
- To avoid confounding from other inflammatory conditions individuals with current cancer, heart, kidney or liver disease, gallbladder disease or acute or chronic inflammatory diseases (including rheumatoid arthritis, lupus and other autoimmune diseases and genetic diseases) will be excluded
- Pregnant women will be excluded, as they will not be eligible for bariatric surgery
- Current smokers
- Currently abusing alcohol or drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abeer Mohamed, MD, PhD
University of Illinois at Chicago
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Postdoctoral Research Associate
Study Record Dates
First Submitted
May 3, 2018
First Posted
May 17, 2018
Study Start
October 11, 2019
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
September 15, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, CSR
- Time Frame
- Month 30-36
All data obtained will be shared with the public openly via publication in the most rigorous, visible and appropriate scientific journals possible. Data will be published as soon as it is reasonable to do so (i.e., sufficient data generated to warrant a suitable paper). Supplemental data for each published paper will be made available in one location on the laboratory webpage of the applicant and her mentor. The applicant and other investigators are open to collaboration with outside groups as well when there is mutual interest in this approach. In accordance to the NIH public access requirement (Section 218), we will submit to the National Library of Medicine's PubMed Central an electronic version of our final peer-reviewed manuscripts upon acceptance for publication to be made public no later than 12 months after the official date of publication. We will make every effort to keep findings of this research project widely available and accessible to the research community.