Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Obesity

Prostatic Neoplasms

Adenocarcinoma

Obesity, Morbid

Overweight

Overnutrition

Nutrition Disorders

Body Weight

All Drugs and Chemicals

Antineoplastic Agents

Reproductive Control Agents

Hormones

Leuprolide

Antineoplastic Agents, Hormonal

After enrollment in the clinical trial, all men will be enrolled in diet and exercise counseling through the weight management program for a total of 4 weeks. If participants lose \>5 pounds of total body weight from weight management alone in the first 4 weeks, these participants will be excluded from study and will not undergo BAE but will be encouraged to continue with weight management. Those still enrolled will undergo BAE. Within 7 days of BAE, men will be given ADT (lupron subcutaneous injection).

These patients will undergo embolization with 300-500µm Bead Block particles.

Bead Block 300-500 um

All participants will be enrolled in weight management through the Johns Hopkins Weight Management Center. During weeks -4 through 0, participants will be required to go to weekly visits. Weight management will include counseling on diet, exercise and behavior change. Food programs, pharmacotherapy and other procedures will not be utilized.

Weight Management

22.5 mg will be given as a single intramuscular or subcutaneous injection once every 12 weeks according to the standard of care for prostate cancer. If leuprolide acetate, 22.5 mg for 3-month administration is not available, a suitable substitute may be allowed upon approval by the principle investigator

Lupron

Catherine Marshall, M.D.

The standard of care for obese men starting Androgen deprivation therapy (ADT) is physician based dietary and exercise counseling. Interventions to lessen the harmful effects of ADT are needed yet have been limited. Exercise is one strategy that has been attempted however there is conflicting data as to whether or not exercise effectively improves body mass, results in sustained weight loss, improvements in metabolic risk profiles including glucose tolerance and lipid profiles in men starting ADT, or has any effect of progression of cancer. Dietary interventions have been attempted without clear improvement in weight, metabolic factors, quality of life or cancer progression. Bariatric arterial embolization (BAE), given it results in weight loss in obese men and women without cancer, may be able to stave off the harmful side effects of ADT by inducing weight loss. Therefore, the investigators hypothesize that Bariatric Arterial embolization (BAE), done prior to initiation of ADT, will mitigate the weight gain and metabolic side effects associated with ADT, by inducing weight loss of at least 5% in obese men with biochemical recurrent prostate cancer starting ADT.

The primary objective is to determine if BAE, done prior to ADT initiation in obese men (with obesity related comorbid condition) with biochemically recurrent prostate cancer, can induce 5% or greater weight loss at 6 months.

Bariatric Arterial Embolization for Men Starting Hormones for Prostate Cancer

BASH-PC: Bariatric Arterial Embolization for Men Starting Hormones for Prostate Cancer

The amount of Time (months) till prostate-specific antigen (PSA) progression which will be assessed by PSA blood test at screening, 12 weeks, 24 weeks, 36 weeks, and 48 weeks. With PSA progression defined as first PSA increase that is 25% and 2ng/mL above the nadir, and which is confirmed by a second value at least 3 weeks later, or the amount of Time till radiographic progression which will be assessed by RECIST v1.1 using conventional CT chest/abd/pelvis or NM Bone scan. Radiographic progression will be defined as visceral and nodal disease or at least 2 new bone lesions.

C-Reactive Protein (CRP) levels in mg/dL.

Erythrocyte Sedimentation Rate (ESR) in millimeters per hour.

Tumor Necrosis Factor Alpha (TNF-α) levels in pg/mL.

Interleukin 1 alpha (IL-1α) levels in pg/mL.

Interleukin 1 beta (IL-1β) levels in pg/mL.

Active Glucagon-like Peptide-1 (GLP-1) levels in pmol/L.

Insulin-like growth factor 1 (IGF-1) levels in ng/mL.

To evaluate changes in the microbiome of men with prostate cancer before and after undergoing BAE and starting ADT.

High density lipoprotein (HDL) levels in mg/dL.

Fasting glucose (mg/dL) will be assessed at specified time points for any changes. Fasting glucose within normal is \<126 mg/dL.

Hemoglobin A1c levels in percentage will be assessed at 12 weeks, 24 weeks, 36 weeks, and 48 weeks.

Low density lipoprotein (LDL) levels in mg/dL.

Quality of Life scored on a scale from 0 to 48, higher scores representing highest level of functioning possible.

Impact of Weight on Quality of Life all 31 questions are scored on a scale from 1 to 5, higher scores representing poorer quality of life.

The global PSQI score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

All questions are scored on a scale from 0 to 100. The total score from all of the questions answered is divided by the total number of the questions answered yielding a global score from 0-100 with 100 representing the highest level of functioning possible.

Fatigue Rated by 9 each item on a 0-10 and 1 on a yes no scale, higher scores representing more fatigue.

Number of participants who experience at least 5 percent weight loss at 6 months after BAE.

Number of adverse events will be assessed to determine if there are any increased adverse events in men with prostate cancer undergoing BAE.

Blood pressure (mmHg) will be assessed for changes over the specified time points.

Respiratory rate in breaths per minute will be assessed for changes over the specified time points.

Oxygen saturation (percentage) will be assessed for changes over the specified time points.

Maryland Cigarette Restitution Fund

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Hernia

Prolapse

Pelvic Organ Prolapse

Genital Diseases, Female

Mediastinal Neoplasms

Hernia, Inguinal

Hernia, Ventral

Thymoma

Thymus Neoplasms

Prostatic Diseases

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Pathological Conditions, Anatomical

Hernia, Abdominal

Neoplasms by Histologic Type

Thoracic Neoplasms

Lymphatic Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Mediastinal Diseases

Thoracic Diseases

Respiratory Tract Diseases

Subjects scheduled to undergo robotic-assisted surgery

Robotic-assisted Surgery

This prospective, multicenter, single-arm study is being conducted to confirm safety, effectiveness, and usability of da Vinci Surgical System in performing robotic-assisted surgical procedures.

Clinical Investigation of the da Vinci Surgical System

A Prospective, Multicenter Clinical Investigation of the da Vinci Surgical System

Effectiveness defined as the ability to complete the planned da Vinci robotic-assisted procedures without conversion to open.

Safety defined as the incidence of all intra-operative and post-operative adverse events that occur through the 30-day follow-up period.

Intuitive Surgical

Gland and Hormone Related Diseases

Digestive System Diseases

Heart and Blood Diseases

Nervous System Diseases

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Ear, Nose, and Throat Diseases

Diabetes Mellitus

Diabetes Mellitus, Type 2

Hyperlipoproteinemias

Hyperlipidemias

Intestinal Diseases

Hypertension

Gastroesophageal Reflux

Weight Loss

Apnea

Sleep Apnea Syndromes

Gastrointestinal Diseases

Rheumatic Diseases

Collagen Diseases

Pain

Musculoskeletal Pain

Somatoform Disorders

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

Esophageal Motility Disorders

Esophageal Spasm, Diffuse

Deglutition Disorders

Esophageal Diseases

Dyslipidemias

Lipid Metabolism Disorders

Muscular Diseases

Neurologic Manifestations

Mental Disorders

Psychotic Disorders

Connective Tissue Diseases

Subjects who have had bariatric surgery for obesity - primary and revision. Bariatric surgical procedures include laparoscopic adjustable gastric banding (LAGB), laparoscopic sleeve gastrectomy (LSG), Roux-en-Y gastric bypass (RYGB), bilio-pancreatic diversion (BPD) with or without duodenal switch (BPD-DS).

Subjects who have had endoscopic bariatric therapies for obesity - primary and revision. Bariatric endoscopic procedures include ablation techniques, intragastric balloons, submucosal tunneling procedures (PSAM, GEM, G-POEM), tissue plication platforms (POSE, ROSE), endoluminal sleeves and endoscopic suturing devices (ESG).

Subjects who follow lifestyle modification and/or anti-obesity medications for treatment of obesity with no previous surgical intervention for obesity. Medical therapies include weight loss diets or anti-obesity medications.

Blood Collection

Urine Collection

Tissue (gastric, duodenum, jejunum and ileum - number of biopsies will be 3-4 from each site, ranging in size from 4-7mm) - These samples collected will be extra biopsies that are taken for research purposes during a clinically planned endoscopy for which biopsies are being planned.

Tissue Sample Collection

Michele B Ryan, MS

Michele B. Ryan, MS

Pichamol Jirapinyo, MD, MPH

The goal of this observational study has the purpose of collecting biological samples from obese patients undergoing evaluation for weight loss by means of medical or endoscopic therapies; and of post bariatric surgery patients presenting with short- and long-term surgical complications. The aim is to enhance the overall understanding of the mechanisms leading to obesity, weight loss, failure to lose weight, and weight regain following treatment. Additional goals are to determine the efficacy of endoscopic and surgical procedures, to identify potential therapeutic targets and disease biomarkers that predict response to therapy.

The prevalence of obesity in the U.S. has reached unacceptably high numbers over the past three decades. Approximately 68% of the American population over the age of 20 is overweight, while 35.7% meet criteria for obesity (CDC). Obesity has become a leading cause of morbidity, mortality and reduced quality of life; and places patients at high risk for several chronic conditions, including: diabetes (DM), hypertension (HTN), hyperlipidemia (HL), sleep apnea, GERD, musculoskeletal disorders and cancer. In addition, obesity imposes a major burden in the American healthcare system, with an estimated annual cost of 147 billion U.S. dollars.

Treatment of obesity is challenging. Preventive measures and medical therapy have not been effective in fighting this epidemic. Diet and exercise, though logical, are hindered by high recidivism and a propensity to regain weight to pre-weight loss levels. Anti-obesity drugs are largely ineffective and limited by safety and side-effects profile. Even bariatric surgery, which provides significant and rapid weight loss, is still followed by substantial weight regain over time. In addition, surgery is associated with a 1% mortality risk, 5-25% 1-year morbidity, and is not readily accessible. Fewer than 1% of eligible obese patients undergo surgery each year. In face of all these challenges, there is an urgent need to better understand the pathophysiology of obesity and the effects of current weight loss interventions. This knowledge will provide a new framework for the development of more effective preventive measures and therapies.

The pathophysiology of obesity is complex. Weight gain results from an energy imbalance; that is, when energy intake is higher than expenditure. In this context, obesity has been attributed to a shift in diet toward increased consumption of energy-dense foods, and to sedentary lifestyle. However, little is known about the physiological mechanisms underlying this trend, which are thought to be regulated by genetic, metabolic and neurobehavioral factors. Even less is understood on how increased adiposity leads to the development of many metabolic disorders, including DM. Surprisingly, these mechanisms can be reversed by bariatric procedures, which in addition to weight loss, have dramatic beneficial effects on metabolic disorders such as DM, HTN, and HL. Therefore, surgery has become an important study tool to enhance our understanding of the pathophysiology of obesity. The collection of biological samples from patients before and after weight loss therapies, including endoscopic and surgical procedures, will provide the basis for a series of studies that will focus on investigating:

* the mechanisms that lead to obesity, particularly appetite and gut regulatory peptides;
* the clinical, physiological, hormonal and metabolic changes imposed by medical, surgical and endoscopic procedures to treat obesity;
* the mechanisms of weight regain following bariatric surgery;
* the mechanism of failure to lose weight following endoscopic or surgical procedures;
* the effects of endoscopic procedures on weight regain following bariatric surgery;
* biomarkers that predict response to medical, endoscopic and surgical therapies;
* biomarkers that predict weight regain or therapeutic failures;
* novel therapeutic targets for the treatment of obesity.

Medical therapies include weight loss diets or anti-obesity medications. Bariatric endoscopic procedures include ablation techniques, intragastric balloons, submucosal tunneling procedures (PSAM, GEM, G-POEM), tissue plication platforms (POSE, ROSE), endoluminal sleeves and endoscopic suturing devices (ESG).

Bariatric surgical procedures include laparoscopic adjustable gastric banding (LAGB), laparoscopic sleeve gastrectomy (LSG), Roux-en-Y gastric bypass (RYGB), bilio-pancreatic diversion (BPD) with or without duodenal switch (BPD-DS).

* Blood (serum will be extracted and stored at -80⁰C),
* Urine (stored at -80⁰C),
* Tissue (gastric, duodenum, jejunum and ileum - number of biopsies will be 3-4 from each site, ranging in size from 4-7mm) - These samples collected will be extra biopsies that are taken for research purposes during a clinically planned endoscopy for which biopsies are being planned.
* Data from medical records will be collected including: age, gender, vitals, weight, bmi, graphs, medical history, surgical history, endoscopy reports, radiology reports, labs, demographics, medications, problem list. Investigators do plan to continue collecting data into the future.

Biological Sample Repository for Gastrointestinal Disorders

MGB and non-MGB investigators may request samples (any of the samples listed in this protocol) from this tissue repository. This request will be made after establishing a formal collaboration with investigators in this protocol. Requests will be made in the form of a written document stating the title and purpose of the project, as well as which experimental procedures will be done with the repository samples. In addition to a written request, collaborators will have to share their approved IRB protocol with the investigators in this repository.

Blood (10 ml) will be collected from the enrolled subjects, serum will be extracted and stored at -80 degrees for up to 10 years.

Urine (5 ml) will be collected via free catch method and stored at -80 degrees C for up to 10 years.

Tissue samples (gastric, duodenum, jejunum and ileum - number of biopsies will be 3-4 from each site, ranging in size from 4-7mm) will be collected during a scheduled endoscopic examination. Biopsy tissue will be collected with a large capacity biopsy forceps and deposited into a conical vial containing a freshly prepared balanced salt solution including a HEPES buffer at the bedside, using 5mL of buffered salt solution per 5-10 mm3 of tissue biopsy, at 4 degrees C. Tissue will be stored at -80⁰C until they are "used up" or for up to 10 years from collection.

Tufts University

Boston Children's Hospital

Mayo Clinic

Associate Director of Bariatric Endoscopy

Breast Neoplasms

Breast Diseases

Skin Diseases

Body Weight Changes

The group that lost significant weight after laparoscopic sleeve gastrectomy and was diagnosed with breast cancer

The group who lost significant weight after laparoscopic sleeve gastrectomy and regained it afterwards, or who could not lose weight and were diagnosed with breast cancer

All patients are checked for mammography every year after surgery.

mammography

ANIL ERGİN

anıl ergin

Obesity is an important risk factor for postmenopausal breast cancer. A large meta-analysis concluded that obesity is associated with a 20% to 40% increased risk for receptor-positive postmenopausal breast cancer. The International Agency for Research on Cancer working group on obesity and cancer risk drew similar conclusions. Obesity seems to have the opposite effect among premenopausal women, with most studies suggesting that higher BMI is associated with a reduced risk of premenopausal breast cancer.

Determining whether deliberate weight loss is associated with a reduced risk of breast cancer is difficult in part because sustained weight loss is difficult to achieve and few studies have sufficient statistical power to address this question. Bariatric surgery is one of the few weight loss interventions in which significant weight loss is maintained. A limited number of previous studies have suggested a reduced risk of cancer following bariatric surgery. Recently, it showed that bariatric surgery is associated with a lower risk of several types of cancer, including an approximately 40 % reduction in the risk of postmenopausal breast cancer. However, whether bariatric surgery affects breast cancer risk in premenopausal women and whether this association is altered by estrogen receptor (ER) status has not been addressed.

The aim of this study is to examine the relationship between weight loss after laparoscopic sleeve gastrectomy (LSG) and breast cancer.

In this study, 300 female patients who underwent laparoscopic sleeve gastrectomy due to morbid obesity in Fatih Sultan Mehmet Training and Research Hospital General Surgery Clinic will be included. The number of samples was calculated by performing impact power analysis.

Mamagrophy is recommended for all women over the age of 40 as part of the routine cancer screening program in our country. For this reason, it is assumed that female patients over the age of 40 who have undergone LSG operation have undergone mammography as of 2022. For this reason, the data of these patients will be examined by scanning from the hospital system. Patients who have undergone mammography examination at least 3 years after the LSG operation will be included in the study. The mammograms of the patients who underwent mammography in January 2015 and later will be evaluated. The final diagnosis of breast cancer will be made with the pathology result in patients with suspicious appearance on mamagrophy.

If there is a malignancy detected as a result of the examinations, its size and pathology will be recorded. Patients' age, gender, and total weight loss will be recorded.

In this retrospective study, we aimed to determine the incidence of breast cancer in patients who had undergone LSG surgery and also to determine whether there was a change in breast cancer compared to weight loss.

The patient inclusion criteria are as follows:

* 40 years and older (age as of 2022, not the age of operation)
* LSG was applied in our clinic due to morbid obesity.
* Patients whose mamagrofi images are available in the hospital system

The patient exclusion criteria are as follows:

* Patients who underwent abdominal surgery again after LSG
* Patients whose mamagrophy image is not in the system
* Patients with suspicious findings as a result of mammography and who did not undergo additional imaging or biopsy
* Patients out of follow-up after the operation

Since the incidence of breast cancer was investigated in the study and the incidence of breast cancer in women is much higher than in men, only female patients will be included. Since all patients included in the study would undergo mammography, female patients over the age of 40 were included in the study.

Weight Loss and Breast Cancer

Evaluation of the Relationship Between Weight Loss and Breast Cancer After Laparoscopic Sleeve Gastrectomy Surgery

If there is a request for the sharing of data, it will be shared.

Comparison of breast cancer incidence in those who lost weight after laparoscopic sleeve gastrectomy and those who did not.

Comparison of breast cancer incidence in those who lose weight after laparoscopic sleeve gastrectomy with the normal population

Fatih Sultan Mehmet Training and Research Hospital

Uzman Doktor

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Rectal Diseases

Patients candidates for resective surgery for rectal cancer and also elegible for bariatric surgery

BIB positioning in obese patients with rectal cancer elegible for neoadjuvant therapy

BIB positioning

Mario Musella, MD

Nunzio Velotti

Obesity worsens treatment outcomes in rectal cancer patients: the local resective approach could in fact be more difficult in obese patients due to limited surgical visibility and it has also been reported that high visceral adiposity determines an increased risk of recurrence after chemoradiotherapy neoadjuvant. Bariatric surgery has proved to be the best choice for the treatment of morbid obesity and related comorbidities and in this context, the intragastric balloon (IGB) represents a strategy characterized by a low rate of complications and good results in terms of weight loss.

Therefore, the need to be able to offer obese patients suffering from rectal cancer the possibility of a better recovery perspective, alongside radical oncological surgery and neoadjuvant treatments, also a bariatric surgery such as the positioning of an intragastric balloon.

Epidemiological data show that obesity is associated with a 30-70% increase in the risk of developing rectal cancer; Obesity could also be associated with a worsening of the tumor prognosis, with an increased risk of recurrence and increased mortality. From this point of view, recent studies have shown that a BMI ≥ 30 kg/m2 is associated with higher oncological and functional risks in patients with locally advanced rectal cancer, with lower response rates to neoadjuvant treatment and a less frequent preservation of the anal sphincter.

Obesity also worsens treatment outcomes: the local resective approach could in fact be more difficult in obese patients due to limited surgical visibility and it has also been reported that high visceral adiposity determines an increased risk of recurrence after chemoradiotherapy neoadjuvant. Bariatric surgery has proved to be the best choice for the treatment of morbid obesity and related comorbidities and in this context, the intragastric balloon (IGB) represents a strategy characterized by a low rate of complications and good results in terms of weight loss.

The most recent studies on the subject have shown that IGBs are effective in producing weight loss ranging from 6% to 15% compared to 1% -5% produced by lifestyle interventions alone Therefore, the need to be able to offer obese patients suffering from rectal cancer the possibility of a better recovery perspective (reduction of intra- and peri-operative complications, increased disease-free survival and lower risk of long-term recurrence) is underlined. ), alongside radical oncological surgery and neoadjuvant treatments, also a bariatric surgery such as the positioning of an intragastric balloon.

Evaluation of Surgical Complications and DFS in Obese Rectal Cancer Patients

Evaluation of Intra- and Peri-operative Complications and Disease-free Survival in Rectal Cancer Patients Undergoing Oncological Resective Surgery and Concomitant Bariatric Surgery

Peri-operative complications during rectal cancer surgery

Overall survival for patients with rectal cancer underwent resective surgery after BIB positioning

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bariatric Arterial Embolization for Men Starting Hormones for Prostate Cancer	NCT04331717	Prostate Adenoc... Obesity, Morbid	Bead Block 300-... Weight Manageme... Lupron	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Clinical Investigation of the da Vinci Surgical System	NCT05682742	Thymoma Mediastinal Tum... Gynecologic Dis... Gynecologic Can... Pelvic Organ Pr... Prostate Diseas... Prostate Cancer Inguinal Hernia Ventral Hernia Obesity, Morbid	Robotic-assiste...	21 Years -	Intuitive Surgical
Biological Sample Repository for Gastrointestinal Disorders	NCT05874726	Obesity Obesity, Morbid Obesity, Primar... Gastro-Intestin... Overweight and ... Overweight Overweight or O... Diabetes Type 2 Diabetes Mellit... Diabetes Mellit... Hypertension Hyperlipidemias Sleep Apnea GERD Gastroesophagea... Musculoskeletal... Cancer	Blood Collectio... Urine Collectio... Tissue Sample C...	18 Years -	Brigham and Women's Hospital
Weight Loss and Breast Cancer	NCT05654571	Breast Cancer Obesity, Morbid	mammography	40 Years -	Fatih Sultan Mehmet Training and Research Hospital
Biological Sample Repository for Gastrointestinal Disorders	NCT05874726	Obesity Obesity, Morbid Obesity, Primar... Gastro-Intestin... Overweight and ... Overweight Overweight or O... Diabetes Type 2 Diabetes Mellit... Diabetes Mellit... Hypertension Hyperlipidemias Sleep Apnea GERD Gastroesophagea... Musculoskeletal... Cancer	Blood Collectio... Urine Collectio... Tissue Sample C...	18 Years -	Brigham and Women's Hospital
Evaluation of Surgical Complications and DFS in Obese Rectal Cancer Patients	NCT06056726	Obesity, Morbid Rectal Cancer Surgery-Complic...	BIB positioning	18 Years - 70 Years	Federico II University

Spots Global Cancer Trial Database for obesity, morbid