BAriatric Surgery Induced Chromosomal Change (BASICC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity, Morbid

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 Type: Observational
• Enrollment (Estimated): 126

Contacts and Locations

Study Locations

• United States
  • Florida
    • Weston, Florida, United States, 33331
      • Recruiting
      • Cleveland Clinic Florida
      • Contact: Raul J Rosenthal, MD; Phone Number: 954-659-5228; Email: rosentr@ccf.org
      • Contact: Pauline Aeschbacher, MD; Phone Number: (954) 659 5228; Email: aeschbp@ccf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2023
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: June 6, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Telomere length; Metabolic and bariatric surgery
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 23-488

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No