ObesityNCT06138821
Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial
A study testing ESG + lifestyle modification and Lifestyle modification in people with Obesity and Liver Diseases, run by Pichamol Jirapinyo, MD, MPH at 2 sites in United States.
Trial summary
Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease globally. While weight loss through lifestyle modification is the standard treatment, most patients regain weight limiting ultimate improvement in liver disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Liver Diseases, Liver Fibrosis
- What is being tested?
- ESG + lifestyle modification and Lifestyle modification
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Jun 2025to Jun 2028
- Phase
- Interventional
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 (male or female)
- BMI ≥30 kg/m2 or ≥27 kg/m2 with at least one obesity-related comorbidity
- Self-reported stable weight (no weight change >5%) for 6 months prior to the first study visit
- Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory/imaging/additional tests, and completing diet counseling
- Willingness to NOT start a new anti-obesity medication for the following 12 months
- Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete routine follow-up visits
- Ability to give informed consent
- Women of childbearing potential (i.e., not post-menopausal, nor surgically sterilized) must agree to use adequate birth control methods
Who cannot join
- Known history of other chronic liver diseases (viral hepatitis, autoimmune hepatitis, drug-induced hepatitis, and genetic)
- Treatment with vitamin E (at doses ≥800 IU/day), pioglitazone, obeticholic acid, or resmetirom <90 days before the first study visit
- History of foregut or gastrointestinal (GI) surgery (except uncomplicated fundoplication, cholecystectomy or appendectomy)
- Prior bariatric surgery
- Prior endoscopic sleeve gastroplasty
- Any inflammatory disease of the GI tract, including severe (LA Grade C or D) esophagitis, Barrett's esophagus with dysplasia, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease
Show all 29Show fewer
- Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses
- Severe gastroesophageal reflux disease (GERD)
- A structural abnormality in the esophagus or pharynx, such as a stricture or diverticulum, that could impede passage of the endoscope.
- Achalasia or any other severe esophageal motility disorder
- Chronic abdominal pain
- Gastroparesis or intractable constipation
- Hepatic insufficiency or cirrhosis
- Severe coagulopathy
- Insulin-dependent diabetes (either type 1 or type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or HgbA1C ≥ 12%
- Patients on an anti-platelet agent, anticoagulant agent or chronic/routine use of NSAIDs
- Patients on corticosteroids, immunosuppressants, or narcotics
- Patients on an anti-seizure or anti-arrhythmic medication
- Patients who are pregnant or breastfeeding
- Excessive alcohol consumption (>20 g per day for women; >30 g per day for men)
- Active smoking
- History of poorly controlled hypertension, coronary artery disease, congestive heart failure, cardiac arrhythmia
- History of respiratory diseases such as chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer
- History of autoimmune connective tissue disorder such as lupus, scleroderma or immunocompromised disease
- History of active malignancy
- History of genetic or hormonal causes for obesity, such as Prader Willi syndrome
- History of endocrine disorders affecting weight, such as uncontrolled hypothyroidism
- Eating disorders, including night eating syndrome, bulimia, binge eating disorder or compulsive overeating
- Active psychological issues preventing participation in a lifestyle modification program as determined by a psychologist
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Michele B. Ryan, MS, 617-525-8266, mryan@bwh.harvard.edu
Pichamol Jirapinyo, MD, MPH
- Recruiting
West Virginia University
Morgantown, West Virginia, 26506
Soban Researcher, 304-293-4946, muhammadsobanarif.maan@hsc.wvu.edu
Shailendra Singh, MD
About this study
Official title: Effect of Endoscopic Sleeve Gastroplasty on Patients With Obesity and Concomitant Metabolic Dysfunction-Associated Steatohepatitis (MASH): A Multicenter, Open-label, Randomized Controlled Trial
Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease globally. While weight loss through lifestyle modification is the standard treatment, most patients regain weight limiting ultimate improvement in liver disease. On the other end of the spectrum, bariatric surgery has shown promise in the treatment of MASLD/metabolic dysfunction-associated steatohepatitis (MASH) due to its efficacy in inducing weight loss. Nevertheless, its adoption has been hindered by the perceived invasiveness of surgery.
Over the past decade, endoscopic sleeve gastroplasty (ESG) has gained recognition as a promising minimally-invasive approach to weight loss. The procedure involves utilizing a Food and Drug Administration (FDA)-authorized endoscopic suturing device to reduce the gastric volume by 70%. Studies reveal that ESG is associated with approximately 18.2% weight loss at one year after the procedure, with sustained results for at least 10 years. Nevertheless, the effect of ESG on MASH remains unknown.
In this study, the investigators will compare ESG + lifestyle modification versus lifestyle modification alone in treating histologic MASH. The study will randomize patients to one of two different treatment options: ESG + lifestyle modification or lifestyle modification alone.
Read the detailed description
The National Institutes of Health, the World Health Organization, and numerous other scientific organizations including the America Medical Association (AMA) recognize obesity as a chronic disease requiring primary therapy. Almost half of United States (U.S.) adults have obesity. The increasing prevalence of obesity in the U.S. has been accompanied by an increasing prevalence in its associated comorbid conditions including hypertension, diabetes, dyslipidemia, coronary heart disease, stroke, sleep apnea, osteoarthritis, gallbladder disease, GERD, and metabolic dysfunction-associated steatotic liver disease (MASLD)/metabolic dysfunction-associated steatohepatitis (MASH). Obesity is associated with an increased risk of all-cause and cardiovascular mortality and accounts for about 2.5 million preventable deaths annually. The economic consequences of MASH are enormous, with the lifetime cost of care for all patients with MASH projected to be approximately $222 billion as of 2017.
Current treatment options for patients with MASLD/MASH are limited to weight loss via lifestyle modification and more recently, Food and Drug Administration (FDA)-approved medications, such as resmetirom and semaglutide, indicated specifically for patients with MASH and F2-F3 fibrosis. Nevertheless, less than 10% of patients who undergo lifestyle modification experience at least 10% total weight loss (TWL), the threshold required for hepatic fibrosis regression. The available pharmacological approaches for the treatment of obesity increase weight loss by 3% to 9% compared with lifestyle therapy alone, but some can be associated with unfavorable side effects, significant cost, and weight loss achieved by pharmacotherapy is rarely maintained upon withdrawal of the medication. On the other end of the spectrum, bariatric surgery, such as Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy, has shown promise in the treatment of MASLD/MASH due to its ability to induce significant and durable weight loss of at least 10% TWL. Nevertheless, its adoption has been limited with less than 2% of patients eligible for the surgery choosing to undergo the procedure. This is likely due to the perceived invasiveness of surgery, high costs, and limited access. More importantly, the majority of patients with mild to moderate (class I and class II obesity (BMI 30-40 kg/m2)), who do not qualify for bariatric surgery are left without an effective management, considering the modest effects seen with medications or lifestyle intervention alone and their ability to achieve >10%TWL only in the minority of patients. Yet, according to the global disability-adjusted life-years and deaths study, patients with mild to moderate obesity are the highest contributors to the burden on disease both in terms of co-morbidities and overall mortality. Therefore, both government agencies (the Agency for Healthcare Research and Quality [AHRQ]) and national societies (American Society of Bariatric and Metabolic Surgery [ASMBS], and American Society of Gastrointestinal Endoscopy [ASGE]) now recognize that a significant management gap exists for patients with mild to moderate obesity and have defined safety and efficacy thresholds for adoption of a new treatment category- endoscopic weight loss interventions.
Over the past decades, endoscopic bariatric and metabolic therapies (EBMTs) have been developed to fill the treatment gap for obesity and MASLD/MASH. Specifically, compared to lifestyle modification, EBMTs are associated with greater weight loss with a higher proportion of patients reaching the 10% TWL threshold. Additionally, given its non-surgical, minimally-invasive nature, the safety profile for EBMTs appears more favorable compared to bariatric surgery. To date, there are two EBMT devices and/or procedures that are approved or cleared by the Food and Drug Administration (FDA). These include intragastric balloons (IGBs) and endoscopic sleeve gastroplasty (ESG).
The ESG procedure is an endoscopic minimally-invasive weight loss procedure where a commercially available, FDA-approved, full-thickness endoscopic suturing device (Overstitch; Boston Scientific, Marlborough, MA) is used to reduce the stomach volume by 70% through the creation of a restrictive endoscopic sleeve. This is accomplished by a series of endoluminally placed full-thickness stitches through the gastric wall, extending from the distal gastric body to the proximal gastric body. The investigators currently perform this procedure as a standard of care at Brigham and Women's Hospital (BWH). Our previous studies have demonstrated that ESG not only leads to significant weight loss of at least 10% TWL, but also improves non-invasive tests (NITs) of liver steatosis and fibrosis, as well as MASH histologic features in patients with obesity and concomitant MASH. Nevertheless, it remains unclear if ESG is superior to lifestyle modification alone.
Clinical Data to Date
The feasibility of ESG was first demonstrated in humans in the US in 2013. Since then, the technique has gained wide clinical adoption in the US and worldwide with thousands of cases performed. Multiple single-arm prospective and retrospective studies have demonstrated the safety and minimally invasive nature of the technique and reported %TWL of about 16% to 18% at 12 months. Furthermore, studies have demonstrated physiologic perturbations resulting from creation of the ESG and its association with increased satiation and metabolic effects that are potentially important to control the metabolic dysregulation associated with obesity. In a recent randomized controlled trial including 209 participants, subjects were randomized to either ESG combined with lifestyle modification (n=85) or lifestyle modification alone (n=124). At 12 months, the ESG group achieved significantly greater weight loss of 13.6% TWL, compared to 0.8% in the control group. ESG-related serious adverse events occurred in only 2% of participants, with no instances of mortality, intensive care, or surgery required. While ESG has demonstrated both safety and efficacy for weight loss, no RCTs have yet assessed its impact on obesity-related comorbidities.
- Conditions
- Obesity, Liver Diseases, Liver Fibrosis, Liver Fat, Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
- Being tested
- ESG + lifestyle modification, Lifestyle modification
- Keywords
- Gut Hormones, Endoscopic Bariatric and Metabolic Therapy (EBMT), Intragastric Balloon (IGB), Endoscopic Suturing, Endoscopic Sleeve Gastroplasty (ESG), Weight Management, Endoscopic Gastric Remodeling (EGR), Endoscopic Bariatric Therapy (EBT), Fatty Liver, Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Metabolic Dysfunction-Associated Steatohepatitis (MASH), Non-Alcoholic Fatty Liver Disease (NAFLD), Non-Alcoholic Steatohepatitis (NASH)
- Medical subject headings
- Obesity, Liver Diseases, Liver Cirrhosis, Fatty Liver, Weight Loss, Insulin Resistance, Metabolic Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESG + lifestyle modificationDevice
Also called Endoscopic sleeve gastroplasty, Endoscopic suturing
Endoscopic sleeve gastroplasty - an endoscopic weight loss procedure where an endoscopic suturing device is utilized to reduce the size of the stomach by 70%.
Lifestyle modificationBehavioural
Lifestyle modification program consisting of diet and exercise therapy
| Study group | Role | What they receive |
|---|---|---|
| ESG + lifestyle modification | Experimental | Endoscopic sleeve gastroplasty weight loss procedure with a lifestyle modification program for 12 months. Receives: Device: ESG + lifestyle modification; Behavioral: Lifestyle modification |
| Lifestyle modification | Active comparator | Lifestyle modification program for 12 months. Receives: Behavioral: Lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
MASH resolution without worsening of liver fibrosis at 12 months
Comparison of endoscopic ultrasound (EUS)-guided liver biopsy results to assess MASH resolution at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group.
Measured: Baseline, 12 months
Secondary outcomes (22)
An improvement of liver fibrosis by at least one stage without worsening of MASH at 12 months
Comparison of endoscopic ultrasound (EUS)-guided liver biopsy results to assess an improvement of liver fibrosis at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group.
Measured: Baseline, 12 months
Change in liver stiffness on MRE at 12 months
Comparison of liver stiffness measurement on magnetic resonance elastography (MRE) at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group.
Measured: Baseline, 12 months
Change in liver stiffness on VCTE at 12 months
Comparison of liver stiffness measurement on vibration-controlled transient elastography (VCTE) at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group.
Measured: Baseline, 12 months
Change in liver fibrosis using NFS at 12 months
Comparison of NAFLD fibrosis score (NFS) at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group.
Measured: Baseline, 12 months
Change in liver fibrosis using ELF score at 12 months
Comparison of ELF at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group.
Measured: Baseline, 12 months
Change in liver fibrosis using FIB-4 at 12 months
Comparison of Fibrosis-4 (FIB-4) score at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group.
Measured: Baseline, 12 months
Change in liver fat content using MRI-PDFF at 12 months
Comparison of liver fat content using MRI proton density fat fraction (MRI-PDFF) at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group.
Measured: Baseline, 12 months
Change in liver fat content using VCTE CAP score at 12 months
Comparison of liver fat content measured by controlled attenuation parameter (CAP) score on vibration-controlled transient elastography (VCTE) at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group.
Measured: Baseline, 12 months
Change in portosystemic pressure gradient (PPG) measurements at 12 months
Comparison of portosystemic pressure gradient (PPG) measurements at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group.
Measured: Baseline, 12 months
Percent total weight loss (%TWL) at 12 months
Comparison of weight loss at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group.
Measured: Baseline, 1, 3, 6 and 12 months
Change in quality of life at 12 months
Compare changes in quality of life assessed using chronic liver disease questionnaire at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group
Measured: Baseline, 6 and 12 months
Change in eating behaviors at 12 months
Compare changes in eating behaviors evaluated using the Three Factor Eating Questionnaire (TFEQ) at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group.
Measured: Baseline, 6 and 12 months
Change in physical, mental and social well-being at 12 months
Compare changes in physical, mental and social well-being using the Patient-reported Outcomes Measurement Information System (PROMIS) at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group.
Measured: Baseline, 6 and 12 months
Change in insulin resistance at 12 months
Compare changes in insulin resistance using Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Hemoglobin (HbA1c) values at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compraed to LM alone group. groups
Measured: Baseline, 12 months.
Change in gut hormones at 12 months
Compare changes in gut hormones using ghrelin, GIP, GLP-1, PYY values at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compraed to LM alone group. groups
Measured: Baseline, 12 months.
Change in bile acids at 12 months
Compare changes in bile acid values from blood samples at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compraed to LM alone group. groups
Measured: Baseline, 12 months.
Safety parameters post-procedure
Rate of serious adverse events, defined as those classified as grade III-V according to the Clavien-Dindo classification in the ESG + LM group and LM alone group.
Measured: Procedure day, 1, 3, 6, 9 and 12 months
Change in body composition as measured by Dual-Energy X-ray Absorptiometry (DEXA) scan at 12 months (Brigham and Women's Hospital Only)
Comparison of Dual-Energy X-ray Absorptiometry (DEXA) scan measurements at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group.
Measured: Baseline, 12 months
Change in liver stiffness on Shear Wave Elastography at 12 months
Comparison of liver stiffness measurement on Shear wave elastography (SWE) at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group.
Measured: Baseline, 12 months
Change in liver fat content on attenuation imaging (ATT) at 12 months
Comparison of liver fat content measurements using endoscopic attenuation imaging (ATT) at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group.
Measured: Baseline, 12 months
Change in grip strength measurements at 12 months (Brigham and Women's Hospital Only)
Comparison of grip strength measurements using a handheld dynamometer at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group.
Measured: Baseline, 12 months
Change in physical performance measurements at 12 months (Brigham and Women's Hospital Only)
Comparison of physical performance measurements based on a 6-meter walk test at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group.
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start24 Jun 2025
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized, controlled, open-label clinical trial.
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pichamol Jirapinyo, MD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation, Cook Group Incorporated
- Responsible party
- Sponsor-investigator, Pichamol Jirapinyo, MD, MPH, Brigham and Women's Hospital
- Investigators
- Pichamol Jirapinyo, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138821
- Sponsor's protocol ID
- 2024P002282
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data sharing will be considered on a case by case basis with a presentation of research protocol to the PI. Data will only be shared with a proper data transfer agreement in place between Brigham and Women's Hospital and the Institution of the requesting investigator.
Publications
Flegal KM, Carroll MD, Ogden CL, Curtin LR. Prevalence and trends in obesity among US adults, 1999-2008. JAMA. 2010 Jan 20;303(3):235-41. doi: 10.1001/jama.2009.2014. Epub 2010 Jan 13.
PubMed 20071471Flegal KM, Kit BK, Orpana H, Graubard BI. Association of all-cause mortality with overweight and obesity using standard body mass index categories: a systematic review and meta-analysis. JAMA. 2013 Jan 2;309(1):71-82. doi: 10.1001/jama.2012.113905.
PubMed 23280227Adams KF, Schatzkin A, Harris TB, Kipnis V, Mouw T, Ballard-Barbash R, Hollenbeck A, Leitzmann MF. Overweight, obesity, and mortality in a large prospective cohort of persons 50 to 71 years old. N Engl J Med. 2006 Aug 24;355(8):763-78. doi: 10.1056/NEJMoa055643. Epub 2006 Aug 22.
PubMed 16926275Prospective Studies Collaboration; Whitlock G, Lewington S, Sherliker P, Clarke R, Emberson J, Halsey J, Qizilbash N, Collins R, Peto R. Body-mass index and cause-specific mortality in 900 000 adults: collaborative analyses of 57 prospective studies. Lancet. 2009 Mar 28;373(9669):1083-96. doi: 10.1016/S0140-6736(09)60318-4. Epub 2009 Mar 18.
PubMed 19299006Finkelstein EA, Trogdon JG, Cohen JW, Dietz W. Annual medical spending attributable to obesity: payer-and service-specific estimates. Health Aff (Millwood). 2009 Sep-Oct;28(5):w822-31. doi: 10.1377/hlthaff.28.5.w822. Epub 2009 Jul 27.
PubMed 19635784Cawley J, Meyerhoefer C. The medical care costs of obesity: an instrumental variables approach. J Health Econ. 2012 Jan;31(1):219-30. doi: 10.1016/j.jhealeco.2011.10.003. Epub 2011 Oct 20.
PubMed 22094013Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2985-3023. doi: 10.1016/j.jacc.2013.11.004. Epub 2013 Nov 12. No abstract available.
PubMed 24239920Stevens VJ, Obarzanek E, Cook NR, Lee IM, Appel LJ, Smith West D, Milas NC, Mattfeldt-Beman M, Belden L, Bragg C, Millstone M, Raczynski J, Brewer A, Singh B, Cohen J; Trials for the Hypertension Prevention Research Group. Long-term weight loss and changes in blood pressure: results of the Trials of Hypertension Prevention, phase II. Ann Intern Med. 2001 Jan 2;134(1):1-11. doi: 10.7326/0003-4819-134-1-200101020-00007.
PubMed 11187414Gregg EW, Chen H, Wagenknecht LE, Clark JM, Delahanty LM, Bantle J, Pownall HJ, Johnson KC, Safford MM, Kitabchi AE, Pi-Sunyer FX, Wing RR, Bertoni AG; Look AHEAD Research Group. Association of an intensive lifestyle intervention with remission of type 2 diabetes. JAMA. 2012 Dec 19;308(23):2489-96. doi: 10.1001/jama.2012.67929.
PubMed 23288372Look AHEAD Research Group; Pi-Sunyer X, Blackburn G, Brancati FL, Bray GA, Bright R, Clark JM, Curtis JM, Espeland MA, Foreyt JP, Graves K, Haffner SM, Harrison B, Hill JO, Horton ES, Jakicic J, Jeffery RW, Johnson KC, Kahn S, Kelley DE, Kitabchi AE, Knowler WC, Lewis CE, Maschak-Carey BJ, Montgomery B, Nathan DM, Patricio J, Peters A, Redmon JB, Reeves RS, Ryan DH, Safford M, Van Dorsten B, Wadden TA, Wagenknecht L, Wesche-Thobaben J, Wing RR, Yanovski SZ. Reduction in weight and cardiovascular disease risk factors in individuals with type 2 diabetes: one-year results of the look AHEAD trial. Diabetes Care. 2007 Jun;30(6):1374-83. doi: 10.2337/dc07-0048. Epub 2007 Mar 15.
PubMed 17363746Yanovski SZ, Yanovski JA. Long-term drug treatment for obesity: a systematic and clinical review. JAMA. 2014 Jan 1;311(1):74-86. doi: 10.1001/jama.2013.281361.
PubMed 24231879Wing RR, Lang W, Wadden TA, Safford M, Knowler WC, Bertoni AG, Hill JO, Brancati FL, Peters A, Wagenknecht L; Look AHEAD Research Group. Benefits of modest weight loss in improving cardiovascular risk factors in overweight and obese individuals with type 2 diabetes. Diabetes Care. 2011 Jul;34(7):1481-6. doi: 10.2337/dc10-2415. Epub 2011 May 18.
PubMed 21593294Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide 2011. Obes Surg. 2013 Apr;23(4):427-36. doi: 10.1007/s11695-012-0864-0.
PubMed 23338049GBD 2015 Obesity Collaborators; Afshin A, Forouzanfar MH, Reitsma MB, Sur P, Estep K, Lee A, Marczak L, Mokdad AH, Moradi-Lakeh M, Naghavi M, Salama JS, Vos T, Abate KH, Abbafati C, Ahmed MB, Al-Aly Z, Alkerwi A, Al-Raddadi R, Amare AT, Amberbir A, Amegah AK, Amini E, Amrock SM, Anjana RM, Arnlov J, Asayesh H, Banerjee A, Barac A, Baye E, Bennett DA, Beyene AS, Biadgilign S, Biryukov S, Bjertness E, Boneya DJ, Campos-Nonato I, Carrero JJ, Cecilio P, Cercy K, Ciobanu LG, Cornaby L, Damtew SA, Dandona L, Dandona R, Dharmaratne SD, Duncan BB, Eshrati B, Esteghamati A, Feigin VL, Fernandes JC, Furst T, Gebrehiwot TT, Gold A, Gona PN, Goto A, Habtewold TD, Hadush KT, Hafezi-Nejad N, Hay SI, Horino M, Islami F, Kamal R, Kasaeian A, Katikireddi SV, Kengne AP, Kesavachandran CN, Khader YS, Khang YH, Khubchandani J, Kim D, Kim YJ, Kinfu Y, Kosen S, Ku T, Defo BK, Kumar GA, Larson HJ, Leinsalu M, Liang X, Lim SS, Liu P, Lopez AD, Lozano R, Majeed A, Malekzadeh R, Malta DC, Mazidi M, McAlinden C, McGarvey ST, Mengistu DT, Mensah GA, Mensink GBM, Mezgebe HB, Mirrakhimov EM, Mueller UO, Noubiap JJ, Obermeyer CM, Ogbo FA, Owolabi MO, Patton GC, Pourmalek F, Qorbani M, Rafay A, Rai RK, Ranabhat CL, Reinig N, Safiri S, Salomon JA, Sanabria JR, Santos IS, Sartorius B, Sawhney M, Schmidhuber J, Schutte AE, Schmidt MI, Sepanlou SG, Shamsizadeh M, Sheikhbahaei S, Shin MJ, Shiri R, Shiue I, Roba HS, Silva DAS, Silverberg JI, Singh JA, Stranges S, Swaminathan S, Tabares-Seisdedos R, Tadese F, Tedla BA, Tegegne BS, Terkawi AS, Thakur JS, Tonelli M, Topor-Madry R, Tyrovolas S, Ukwaja KN, Uthman OA, Vaezghasemi M, Vasankari T, Vlassov VV, Vollset SE, Weiderpass E, Werdecker A, Wesana J, Westerman R, Yano Y, Yonemoto N, Yonga G, Zaidi Z, Zenebe ZM, Zipkin B, Murray CJL. Health Effects of Overweight and Obesity in 195 Countries over 25 Years. N Engl J Med. 2017 Jul 6;377(1):13-27. doi: 10.1056/NEJMoa1614362. Epub 2017 Jun 12.
PubMed 28604169ASGE Bariatric Endoscopy Task Force; Sullivan S, Kumar N, Edmundowicz SA, Abu Dayyeh BK, Jonnalagadda SS, Larsen M, Thompson CC. ASGE position statement on endoscopic bariatric therapies in clinical practice. Gastrointest Endosc. 2015 Nov;82(5):767-72. doi: 10.1016/j.gie.2015.06.038. Epub 2015 Aug 15. No abstract available.
PubMed 26282949