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Obesity and Obesity-related Medical ConditionsNCT06618846

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

An observational study of Obesity and Obesity-related Medical Conditions, run by University Hospital in Krakow at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
laparoscopic sleeve gastric bypass
Type of treatment
Surgery or procedure
How many people
100 participants
Where
1 sitePoland
Study dates
17 Nov 2019to 30 Jun 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • University Hospital Krakow

    Krakow, 30-688

Other trials in Poland

About this study

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:

Read more

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.

Read the detailed description

We would like to invite the participants to take part in a research study carried out at the 2nd Department of General Surgery of the Jagiellonian University CM.

Participation in the study is offered to patients who have qualified for surgical treatment of morbid obesity and have been accepted for laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB) in the Department of Endoscopic, Metabolic and Soft Tissue Surgery. It is well known that morbid obesity contributes to premature aging. One of the topics addressed in recent scientific research is the mechanism of reversal of the aging process in patients undergoing LSG or LRYGB surgery. Assessments of the progression of aging can be carried out by evaluating the age of the body in different contexts. For this purpose, metabolic age - indicating the level of basal metabolism, psychological age - the ability to cognitively function, focus attention, remember, biochemical age - the level of oxidative stress on cells - are determined. A much better parameter for assessing organismal age is telomere length (TL) - molecular age. Telomeres are specialised structures located at the ends of chromosomes - the intracellular structures that carry genetic information. Telomere shortening with age is part of the normal aging process. It has been shown that patients suffering from morbid obesity have shorter telomere lengths compared to people of the same age who have never suffered from obesity, and that telomeres might lengthen after bariatric surgery. However, it is unclear what is responsible for the effect of telomere lengthening, thereby reversing the aging process. The proposed study aims to assess the effect of metabolic surgery on telomere length change and other markers of aging (metabolic age, psychological age, biochemical age, molecular age). The secondary objectives of the study will be to understand the mechanisms responsible for reversing the aging process in bariatric and metabolic surgery patients.

An observational study consisting of two phases was planned. In the first stage, baseline anthropometric and clinical data will be collected on the day of admission to the surgical ward, including the following parameters: age, sex, body weight, height, BMI, duration of obesity, family history of obesity, preoperative weight loss, information on concomitant diseases and medications taken. For the assessment of biochemical and molecular aging, the participants will be asked to consent to the collection of three tubes of peripheral blood.

One blood sample will be preserved in serum tubes for the analysis of inflammatory parameters such as Interleukin-6 (IL-6), C-reactive protein (CRP), Tumor necrosis factor alpha (TNFalpha) and for the determination of the blood antioxidant capacity - total oxidative status (TOS). A second blood sample will be collected into tubes containing an anticoagulant in the form of EDTA for the isolation of DNA for the assessment of DNA damage marker and telomere length. A third blood sample will be preserved in special RNA Pax tubes for testing of expression of genes related to telomere lenghtening. The other markers of aging will include: metabolic age (assessed by bioimpedance scanning, TANITA) and the psychological age determined by using special psychological tests (CTT Colour Connectivity Test and Winscosin Card Sorting Test) for the assessment of cognitive function. Ale the tests will take approximately 30 minutes to be completed.

The second stage of the study will take place 24 months after the operation at the follow-up visit, when all the steps described above will be performed again.

After receiving the results from the first two stages of the study, the third stage will identify the twelve patients (six LSG patients and six LRYGB patients) who will show the greatest difference in telomere length 24 months after surgery and the greatest change in the degree of DNA damage. An in-depth analysis of the expression of genes responsible for telomere lengthening will be carried out in these patients.

This study is an attempt to identify new clinical aspects of the surgical treatment undertaken.The results obtained are expected to help understand the mechanism of premature aging in people suffering from higher stages of obesity, which may in future contribute to the individualisation of perioperative care for bariatric patients and the introduction of prevention programmes.

The decision to participate in the study is completely voluntary. Everyone assesses for themselves whether they have understood the doctor\'s explanations and the written information provided about the trial. The course of treatment is not altered if a decision is made not to participate.

Being tested
laparoscopic sleeve gastric bypass
Keywords
biological age markers, bariatric surgery, metabolic surgery, premature aging
Medical subject headings
Obesity, Aging, Premature

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • laparoscopic sleeve gastric bypassProcedure or surgery

    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)

Study groups in NCT06618846
Study groupRoleWhat they receive
bariatric patientsPatients who were qualified for bariatric or metabolic surgery
Receives: Procedure: laparoscopic sleeve gastric bypass

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2024
  2. Study start17 Nov 2019
  3. Primary completion1 Jul 2020
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06618846
Sponsor's protocol ID
DI2018 013048
Status last verified
Sep 2024
First submitted
20 Sep 2024
Last updated
1 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Obesity-related Medical Conditions, run by University Hospital in Krakow at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The impact of bariatric and metabolic surgery on reduction of premature aging (time frame: Two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.

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