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.
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
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions
- 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.
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 group | Role | What they receive |
|---|---|---|
| bariatric patients | Patients 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.
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.
- First posted1 Oct 2024
- Study start17 Nov 2019
- Primary completion1 Jul 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital in Krakow
- Sponsor type
- University, hospital or other
- Collaborators
- Jagiellonian University
- Responsible party
- Principal investigator, Alicja Dudek, University Hospital in Krakow
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Bariatric and Metabolic Surgery on the Reduction of Premature Aging.
- ClinicalTrials.gov ID
- NCT06618846
- Acronym / sponsor ID
- DI2018 013048
- Keywords
- biological age markers, bariatric surgery, metabolic surgery, premature aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital in KrakowUniversity, hospital or other
- Collaborators
- Jagiellonian University
- Study start
- 17 Nov 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bariatric patients | – | Procedure: laparoscopic sleeve gastric bypassPatients who were qualified for bariatric or metabolic surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic sleeve gastric bypassThis 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) | Procedure or surgery | bariatric patients |
Primary outcome
The impact of bariatric and metabolic surgery on reduction of premature aging
Time frame: Two years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.