Study Stopped
Issue with telomere measurement
BAriatric Surgery Induced Chromosomal Change
BASICC
Long-term Impact of Surgically Induced Rapid Weight Loss on Telomere Length and Its Potential Implications in the Genesis and Prevention of Neoplastic Disease Processes in Subjects With Severe Obesity
1 other identifier
observational
120
1 country
1
Brief Summary
The purpose of this study is to better understand the impact of weight-loss surgery on telomere length. Telomeres are a key marker of biological aging of cells. Telomere shortening is a natural process of aging. Several pathologies and lifestyles are associated with premature telomere shortening, such as obesity, diabetes mellitus or sedentary lifestyle. New evidence supports that telomere shortening can be partially reversed by lifestyle changes such as healthy diet, reduced stress, or increased physical activity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2023
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
June 6, 2023
CompletedStudy Start
First participant enrolled
June 12, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2025
CompletedOctober 24, 2025
October 1, 2025
1.6 years
June 6, 2023
October 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Telomere length
Difference in terms of telomere length between patients with obesity class II or more (Body Mass Index \[BMI\] ≥ 35kg/m2) and patients after metabolic and bariatric surgery.
1 day
Secondary Outcomes (4)
Metabolic disease remission (hypertension and type 2 diabetes remission versus no remission)
1 day
Excessive weight loss (Weight loss [kg] / excess body weight [kg]) x 100 = Percent of excess body weight loss)
1 day
Lifestyle (Simple Lifestyle Indicator Questionnaire)
1 day
Oxidative stress (Interleukin-1β, Interleukin-6, TNF-α)
1 day
Study Arms (2)
Control group
BMI ≥ 35 kg/m2 without previous bariatric surgery
Treatment group
Having had Sleeve Gastrectomy or Roux-en-Y Gastric Bypass more than 12 months ago and without a weight regain of ≥ 15% of nadir weight
Eligibility Criteria
The population will be divided in two groups; the control group (with obesity) and the treatment group (after Sleeve Gastrectomy or Roux-en-Y Gastric Bypass).
You may qualify if:
- BMI ≥ 35 kg/m2 without previous bariatric surgery (control group) OR
- Having had Sleeve Gastrectomy or Roux-en-Y Gastric Bypass more than 12 months ago and without a weight regain of ≥ 15% of nadir weight (treatment group)
You may not qualify if:
- under 18 years of age
- no informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic Florida
Weston, Florida, 33331, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
June 6, 2023
First Posted
June 15, 2023
Study Start
June 12, 2023
Primary Completion
January 20, 2025
Study Completion
January 20, 2025
Last Updated
October 24, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share