BAriatric Surgery Induced Chromosomal Change

Recruiting

• Conditions: Obesity, Morbid

• Registration Number: NCT05903521
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-06
• Study Start: 2023-06-12
• Study First Posted: 2023-06-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-15
• Primary Completion: 2023-10
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Telomere length	1 day	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cleveland Clinic Florida; 🇺🇸 Weston, Florida, United States