Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Obesity

Breast Neoplasms

Overweight

Weight Loss

Body Weight

Breast Diseases

Skin Diseases

Overnutrition

Nutrition Disorders

Body Weight Changes

Alcohol Deterrents

Narcotic Antagonists

All Drugs and Chemicals

Psychotropic Drugs

Anti-Obesity Agents

Anti-Infective Agents

Central Nervous System Depressants

Analgesics

Cardiotonic Agents

Naltrexone

Bupropion

Bupropion hydrochloride, naltrexone hydrochoride drug combination

Ethanol

Narcotics

Antidepressive Agents

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Neurotransmitter Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose \<5%, designated slow responders, will continue BWL and initiate Contrave (SLOW-BWL). The SLOW-BWL arm will receive at least 16 weeks of Contrave \[as per the Food and Drug Administration (FDA) recommended administration\] starting at week 9 and discontinue if ≥5% weight loss is not achieved at month 6.

All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose ≥5%, designated fast responders, will continue with BWL alone (FAST-BWL)

Initiate Contrave at 1 tab in morning (AM) for Week 9; then 1 tab in AM and 1 tab in evening (PM) for Week 10; then 2 tab in AM and 1 tab in PM for Week 11; then 2 tab in AM and 2 tab in PM for week 12; then constant dose for months 4-6.

Contrave

6 months of behavioral weight loss. First 3 months are weekly calls with coach and then transition to monthly calls for months 4-6.

Behavioral Weight Loss

Jennifer Sheng

This is a single arm phase II study designed to determine the effects of pharmacotherapy and a remote behavioral weight loss intervention on weight loss in breast cancer survivors who are overweight or obese, and the impact of successful weight loss on serum biomarkers and gut microbiome.

The investigators will evaluate the extent to which implementation of a chronic weight loss medication, Contrave® (Naltrexone/Bupropion), is associated with achieving ≥5% weight loss. All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose ≥5%, designated fast responders, will continue with BWL alone (FAST-BWL) while those who lose \<5%, designated slow responders, will continue BWL and initiate Contrave (SLOW-BWL). The SLOW-BWL arm will receive at least 16 weeks of Contrave (as per Federal Drug Administration \[FDA\] recommended administration) starting at week 9 and discontinue if ≥5% weight loss is not achieved at month 6. During month 3, all participants continue to have weekly calls with the behavioral coach and will be asked about symptoms, which may be related to initiation of pharmacotherapy; any symptoms are reported to the PI for further evaluation. In addition to total weight loss, the investigators will evaluate biomarkers associated with obesity, microbiome and cardiometabolic factors.

Adaptive Nutrition and Exercise Weight Loss (A-NEW) Study

A Phase II Single Arm Adaptive Weight Loss Study in Women With Early Stage Breast Cancer

To assess the proportion of women in the FAST-BWL arm who maintain ≥5% weight loss at 6 months.

To assess prevalence of AA genotype of MnSOD in breast cancer survivors with excess weight and if a greater proportion of women with the AA genotype achieve ≥5% weight loss and improvement in biomarkers at 6 months compared to the women who do not.

To determine if women who display the AA genotype of MnSOD and undergo addition of Contrave to BWL have greater weight loss compared to women who do not receive Contrave.

To assess the rate of SLOW-BWL patients attaining at least 5% weight loss of their baseline body weight at 6 months with the addition of Contrave to BWL at week 9.

To compare HbA1c (%) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

To compare HbA1c (%) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

To compare HbA1c (%) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

To compare Insulin-like growth factor 1 (IGF1) (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

To compare IGF1 (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss

To compare IGF1 (ng/mL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

To compare fasting glucose (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

To compare fasting glucose (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

To compare fasting glucose (mg/dL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

To compare fasting lipids (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

To compare fasting lipids (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

To compare fasting lipids (mg/dL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

To compare fasting insulin (mIU/L) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

To compare fasting insulin (mIU/L) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

To compare fasting insulin (mIU/L) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

To compare adiponectin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

To compare adiponectin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

To compare adiponectin (ng/mL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

To compare leptin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

To compare leptin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

To compare leptin (ng/mL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

To compare microbiome composition (ratio of bacteroides and firmacutes) at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

To compare microbiome composition (ratio of bacteroides and firmacutes) at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

To compare microbiome composition (ratio of bacteroides and firmacutes) at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

To compare Godin (score range start from 0 with no upper limit but higher scores indicate more exercise) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

To compare Godin (score range start from 0 with no upper limit but higher scores indicate more exercise) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

To compare Godin (score range start from 0 with no upper limit but higher scores indicate more exercise) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

To compare PSQI (scores range 0-21 with higher scores indicating poorer sleep) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

To compare PSQI (scores range 0-21 with higher scores indicating poorer sleep) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

To compare PSQI (scores range 0-21 with higher scores indicating poorer sleep) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

To compare Physical Function - Short Form (scores range 10-50 with higher scores indicating better physical functioning) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

To compare Physical Function - Short Form (scores range 10-50 with higher scores indicating better physical functioning) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

To compare Physical Function - Short Form (scores range 10-50 with higher scores indicating better physical functioning) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

To compare Pain Interference - Short Form (scores range 6-30 with lower scores indicating less pain interference) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

To compare Pain Interference - Short Form (scores range 6-30 with lower scores indicating less pain interference) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

To compare Pain Interference - Short Form (scores range 6-30 with lower scores indicating less pain interference) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

To compare Fatigue - Short Form (scores range 7-35 with higher scores indicating more fatigue) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

To compare Fatigue - Short Form (scores range 7-35 with higher scores indicating more fatigue) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

To compare Fatigue - Short Form (scores range 7-35 with higher scores indicating more fatigue) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

To compare Depression - Short Form (scores range 8-40 with lower scores indicating lower levels of depression) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

To compare Depression - Short Form (scores range 8-40 with lower scores indicating lower levels of depression) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

To compare Depression - Short Form (scores range 8-40 with lower scores indicating lower levels of depression) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

To compare Anxiety - Short Form (scores range 7-35 with lower scores indicating lower levels of anxiety) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

To compare Anxiety - Short Form (scores range 7-35 with lower scores indicating lower levels of anxiety) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

To compare Anxiety - Short Form (scores range 7-35 with lower scores indicating lower levels of anxiety) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

To compare Sexual Function (scores range 4-20 with lower scores indicating better sexual functioning) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

To compare Sexual Function (scores range 4-20 with lower scores indicating better sexual functioning) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

To compare Sexual Function (scores range 4-20 with lower scores indicating better sexual functioning) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

To compare NCI quick food scan scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

To compare NCI quick food scan scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

To compare NCI quick food scan scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

To compare FACT-ES (scores range 0-76 with higher scores indicating poorer functional assessment) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.

To compare FACT-ES (scores range 0-76 with higher scores indicating poorer functional assessment) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.

To compare FACT-ES (scores range 0-76 with higher scores indicating poorer functional assessment) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.

To compare minutes of MVPA reported in Fitbit at 2 and 6 months to baseline levels among SLOW-BWL who achieved ≥5% weight loss vs the SLOW-BWL who did not achieve 5% weight loss.

To compare the number of daily steps reported in Fitbit at 2 and 6 months to baseline levels among SLOW-BWL who achieved ≥5% weight loss vs the SLOW-BWL who did not achieve 5% weight loss.

American Institute for Cancer Research

Breast Cancer Research Foundation

Hopkins-WellSpan Cancer Research Fund

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Participants will be randomly assigned to one of eight study groups which will be one or a combination of 4 conditions: (1) in person individualized diet and exercise counseling (2) diet and exercise text messages (3) weekly telephone support and (4) self-monitoring tools for diet and weight. For the first part of the study, Survey, approximately 64 drivers and 36 management staff will take pate in the feedback questionnaire. For the second part of the study, Interview, approximately 8 drivers and 12 management staff may be invited to take part in an interview via phone, in person, or teleconference (Zoom).

Participants will be placed in either individual or group interventions by convenience. Recruitment will be consecutive and participants will be placed in either intervention depending on what resource is available on a given day at the VDS, individual counselor or a group educator.

Conducting SANOS Focus Groups. We will conduct 3-5 focus groups (in Spanish) with 6-10 participants each, until saturation. Bilingual study staff will approach individuals visiting the VDS and VDS Mobile for potential participation. A brief screening questionnaire will be administered, and a BMI assessment conducted, to ascertain eligibility. Focus groups will be scheduled at the VDS Mobile unit at times convenient to participants. Participants will be verbally consented in Spanish, and will be apprised that their participation is purely voluntary and that their names will not be included in the final narrative. The 6-month follow-up and my plate dietary surveys can be done over phone. Study staff will access step counts (or obtain it through phone via the pedometer manual provided to the participant) and upload data onto the REDCap tracking tool. Staff may ask participants to report step counts captured by their personal devices (i.e., phone or smartwatch).

In-person individual diet and physical activity (PA) counseling

Counseling

Thrice-weekly diet/physical activity(PA) text messages

Text Messages

Phone calls

Self-monitoring tools

Jennifer Leng, MD,MPH

Francesca Gany, MD, MS

Jennifer Leng, MD, MPH

The researchers will conduct 'Taxi ROADmAP (Realizing Optimization Around Diet And Physical activity)', which also utilizes MOST, and the same 4 obesity intervention components as in SANOS, but targets the overweight/obesity crisis in another at-risk, low socioeconomic status (SES) population, taxi and for-hire vehicle (FHV) drivers (Lyft, Uber, etc.). ROADMAP also utilizes an effectiveness- implementation hybrid type 1 design. Hybrid trials, which blend effectiveness and implementation studies, can lead to more rapid translational uptake and more effective implementation. Taxi and FHV drivers are a growing, multilingual, hard-to-reach, predominantly immigrant and minority essential worker population. There are over 750,000 licensed taxi and FHV drivers in in the U.S. and over 185,000 in New York City (NYC). They have higher rates of overweight/obese range body mass index (BMI) than New Yorkers in general (77% vs 56%) and have high rates of elevated waist circumference, sedentary behavior, poor diets, and health care services underutilization. ROADmAP will test 4 evidence- and theory-based (Social Cognitive Theory \[SCT\]) behavior change intervention components. We will use MOST to identify which of the 4 components contribute most significantly and cost-effectively to weight loss among NYC drivers recruited at workplace health fairs (HFs) and virtually. Objectives are to apply MOST to design an optimized version of a scalable, lifestyle intervention for taxi/FHV drivers, and then to conduct a mixed methods multistakeholder process evaluation to facilitate widespread intervention implementation.

Taxi ROADmAP (Realizing Optimization Around Diet And Physical Activity)

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Efficacy of intervention is achieved when participants have weight loss with a minimum threshold of 5% of overall body weight lost

Intervention components include:

* Initial in-person individual diet and physical activity (PA) counseling
* Thrice-weekly diet/PA text messages
* Weekly telephone support
* Self-monitoring tools.

Costs associated with each component include: 1) In-person counseling: personnel time, participant travel time, text messaging services; 3) Telephone support: personnel time; 4) Self-monitoring tools: food diaries and digital scales.

The ROADmAP Process Evaluation Questionnaire will be administered to all participants to gather data on implementation potential. Questions are on a Likert scale and will collect intervention delivery facilitators and barriers, intervention sustainability facilitators and barriers post-study completion. Feasibility will be indicated by extreme Likert scores (Strongly Agree, Neutral, Strongly Disagree).

Memorial Sloan Kettering Cancer Center

Gland and Hormone Related Diseases

Digestive System Diseases

Heart and Blood Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Nervous System Diseases

Musculoskeletal Diseases

Behaviors and Mental Disorders

Ear, Nose, and Throat Diseases

Diabetes Mellitus

Diabetes Mellitus, Type 2

Hyperlipoproteinemias

Hyperlipidemias

Intestinal Diseases

Hypertension

Gastroesophageal Reflux

Apnea

Sleep Apnea Syndromes

Gastrointestinal Diseases

Rheumatic Diseases

Collagen Diseases

Pain

Obesity, Morbid

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

Hormones

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adaptive Nutrition and Exercise Weight Loss (A-NEW) Study	NCT04499950	Breast Cancer Overweight or O...	Contrave Behavioral Weig...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Taxi ROADmAP (Realizing Optimization Around Diet And Physical Activity)	NCT05770570	Overweight Overweight and ... Overweight or O... Obesity Obese	Counseling Text Messages Phone calls Self-monitoring...	21 Years -	Memorial Sloan Kettering Cancer Center
Taxi ROADmAP (Realizing Optimization Around Diet And Physical Activity)	NCT05770570	Overweight Overweight and ... Overweight or O... Obesity Obese	Counseling Text Messages Phone calls Self-monitoring...	21 Years -	Memorial Sloan Kettering Cancer Center
Adaptive Nutrition and Exercise Weight Loss (A-NEW) Study	NCT04499950	Breast Cancer Overweight or O...	Contrave Behavioral Weig...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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
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

Spots Global Cancer Trial Database for overweight or obesity