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Trial Title:
BAriatric Surgery Induced Chromosomal Change
NCT ID:
NCT05903521
Condition:
Obesity, Morbid
Conditions: Official terms:
Obesity
Obesity, Morbid
Conditions: Keywords:
Telomere length
Metabolic and bariatric surgery
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
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).
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Cleveland Clinic Florida
Address:
City:
Weston
Zip:
33331
Country:
United States
Status:
Recruiting
Contact:
Last name:
Raul J Rosenthal, MD
Phone:
954-659-5228
Email:
rosentr@ccf.org
Contact backup:
Last name:
Pauline Aeschbacher, MD
Phone:
(954) 659 5228
Email:
aeschbp@ccf.org
Start date:
June 12, 2023
Completion date:
December 2023
Lead sponsor:
Agency:
The Cleveland Clinic
Agency class:
Other
Source:
The Cleveland Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05903521
