Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618846
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Impact of Bariatric and Metabolic Surgery on the Reduction of Premature Aging
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Bariatric and Metabolic Surgery on the Reduction of Premature Aging
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 undertakenThe 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 doctor39s explanations and the written information provided about the trial The course of treatment is not altered if a decision is made not to participate
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 undertakenThe 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 doctor39s 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None