BAriatric Surgery Induced Chromosomal Change

Study Overview
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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.

Official Title
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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

Conditions
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Obesity, Morbid

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>BMI ≥ 35 kg/m2 without previous bariatric surgery | |
| Treatment group<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telomere length, Metabolic and bariatric surgery