Impact of Bariatric and Metabolic Surgery on the Reduction of Premature Aging.

NCT06618846 | Completed DMC

• 1 other identifier: DI2018 013048
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

We invite the participants to take a part in a research study conducted at the 2nd Department of General Surgery of the Jagiellonian University Medical College. This study is for patients who are scheduled for laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB) to treat morbid obesity. Study Purpose: The study aims to assess how obesity surgery impacts aging, specifically by examining changes in telomere length (a marker of molecular age). The research will also evaluate other aspects of ageing, such as metabolic, psychological, and biochemical factors, to understand how surgery may reverse aging. Study Design: The study will be observational and consist of two phases. In the first phase (pre-surgery), clinical and metabolic data will be collected, including blood samples for inflammatory markers, DNA damage tests, and gene expression analysis. Psychological and metabolic age will also be assessed. The second phase will take place 24 months after surgery, with similar tests repeated. A third stage will focus on a detailed gene expression analysis for the 12 patients showing the most significant changes in telomere length and DNA damage. What Will Be The Participants Asked For: The participants will be asked to provide blood samples (for the analysis of: inflammatory markers: C-reactive protein, Tumor necrosis factor alpha, Interleukin-6, marker of DNA damage and total oxidative capacity; the other 2 probes will be collected to analyze telomere length and the probe for RNA to identify gene expression connected to telomere elongation), as well as to complete psychological and metabolic assessments (body composition analysis) in two time points - before and 24 months after surgery. Tests and assessments will take approximately 30 minutes. Voluntary Participation: Participation is entirely voluntary. The participation will NOT affect the treatment at any timepoints. This study seeks to provide new insights into premature aging in patients with morbid obesity, which could help improve care for future bariatric patients. The participants might gain more knowledge about the outcomes of their surgical treatment.

Conditions

Obesity and Obesity-related Medical Conditions

Keywords

biological age markers; bariatric surgery; metabolic surgery; premature aging

Outcome Measures

Primary Outcomes (1)

• The impact of bariatric and metabolic surgery on reduction of premature aging

  The primary outcome will be to determine the effect of metabolic surgery after two years on: telomere length in base pairs, DNA damage in picogram, Interleukin-6 in picogram per mililitr, C-reactive protein in miligram per deciliter, tumor necrosis factor alpha in picogram per milliliter, total oxidative status in micromole per liter and the results of Color Trial Test presented as seconds of test completion and achieved centile.

  Two years

Study Arms (1)

bariatric patients

Patients who were qualified for bariatric or metabolic surgery

Procedure: laparoscopic sleeve gastric bypass

Interventions

laparoscopic sleeve gastric bypass PROCEDURE

This is the observational study that investigate the impact of laparoscopic Sleeve Gastrectomy (LSG) or laparoscopic Roux-en-Y Gastric Bypass on premature aging by the assesment of biological age markers (telomere lenght, IL-6, TNFalpha, total oxidative status, DNA damage, cognitive function)

bariatric patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 patients aged between 18-65 years old who were qualified for the bariatric or metabolic surgery with criteria (BMI values \> 40 kg m2 or BMI \> 35 kg/m2 with obesity related complication), who met the inclusion criteria at the follow up visit after 2 years. All study participants participated in an aftercare programme, which included meetings with a dietician and a psychologist.

You may qualify if:

• BMI values \> 40 kg m2 or BMI \> 35 kg/m2 with obesity related complications, age range between 18 and 60
• consent to participant in the study

You may not qualify if:

• reversal bariatric surgery or previous bariatric surgery, pregnancy during follow up period, uncontrolled thyroid disorders, kidney diseases, pancreatitis, cancer, depression, neurological disorders, any condition affecting cognitive function or consumed medications impairing cognitive functioning
• lack of consent to participant in the study

Sponsors & Collaborators

• University Hospital in Krakow: lead
• Jagiellonian University: collaborator

Study Sites (1)

University Hospital Krakow

Krakow, 30-688, Poland

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA samples to determine telomere lenght RNA samples to determine microRNA from telomerase

MeSH Terms

Conditions

Obesity; Aging, Premature

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD Candidate, Medical Doctor

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 1, 2024
• Study Start: November 17, 2019
• Primary Completion: July 1, 2020
• Study Completion: June 30, 2021
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

PL (1)