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BAriatric Surgery Induced Chromosomal Change

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05903521
Acronym
BASICC
Enrollment
120
Registered
2023-06-15
Start date
2023-06-12
Completion date
2025-01-20
Last updated
2025-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Morbid

Keywords

Telomere length, Metabolic and bariatric surgery

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.

Detailed description

This study aims to evaluate the impact of metabolic and bariatric surgery on telomere length as well as the role of type 2 diabetes resolution and oxidative stress improvement on telomere lengthening. The investigators hypothesize that metabolic and bariatric surgery is associated with the lengthening of telomeres as a possible underlying mechanism of cancer risk reduction. It is a prospective, single-center study including patients with obesity class II or more (Body Mass Index ≥ 35kg/m2) and patients having had metabolic and bariatric surgery more than 12 months ago.

Interventions

None listed

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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)

Exclusion criteria

* under 18 years of age * no informed consent

Design outcomes

Primary

MeasureTime frameDescription
Telomere length1 dayDifference 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.

Secondary

MeasureTime frameDescription
Metabolic disease remission (hypertension and type 2 diabetes remission versus no remission)1 dayEvaluate if remission of metabolic disease (no remission versus remission) has an impact of metabolic disease remission on telomere length after bariatric and metabolic surgery
Excessive weight loss (Weight loss [kg] / excess body weight [kg]) x 100 = Percent of excess body weight loss)1 dayEvaluate if the amount of excessive weight loss has an impact on telomere length after bariatric and metabolic
Lifestyle (Simple Lifestyle Indicator Questionnaire)1 dayEvaluate if lifestyle (Simple Lifestyle Indicator Questionnaire) has an impact of lifestyle on telomere length after bariatric and metabolic
Oxidative stress (Interleukin-1β, Interleukin-6, TNF-α)1 dayEvaluate if oxidative stress level (Interleukin-1β, Interleukin-6, TNF-α) has an impact on telomere length after bariatric and metabolic

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026