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BASICC: BAriatric Surgery Induced Chromosomal Change

Sponsor
The Cleveland Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05903521
Collaborator
(none)
126
Enrollment
1
Location
6
Anticipated Duration (Months)
21
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    126 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    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
    Anticipated Study Start Date :
    Jun 1, 2023
    Anticipated Primary Completion Date :
    Oct 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Control group

    BMI ≥ 35 kg/m2 without previous bariatric surgery
    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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    3. 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

    4. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cleveland Clinic Florida Weston Florida United States 33331

    Sponsors and Collaborators

    • The Cleveland Clinic

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Raul Rosenthal, Prof., The Cleveland Clinic
    ClinicalTrials.gov Identifier:
    NCT05903521
    Other Study ID Numbers:
    • 23-488
    First Posted:
    Jun 15, 2023
    Last Update Posted:
    Jun 18, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Raul Rosenthal, Prof., The Cleveland Clinic
    Telomere length
    Metabolic and bariatric surgery
    Additional relevant MeSH terms:
    Obesity
    Obesity, Morbid

    Study Results

    No Results Posted as of Jun 18, 2023