BAriatric Surgery Induced Chromosomal Change

NCT ID: NCT05903521

Last Updated: 2025-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-12

Study Completion Date

2025-01-20

Brief Summary

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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

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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.

Conditions

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Obesity, Morbid

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

BMI ≥ 35 kg/m2 without previous bariatric surgery

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Emanuele LoMenzo

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cleveland Clinic Florida

Weston, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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23-488

Identifier Type: -

Identifier Source: org_study_id

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