Surgery or Lifestyle With Intensive Medical Management in the Treatment of Type 2 Diabetes
SLIMM-T2D
1 other identifier
interventional
88
1 country
2
Brief Summary
There is substantial clinical evidence regarding the safety and efficacy of currently practiced bariatric surgical techniques to improve metabolic control and/or resolve type 2 diabetes (T2DM) in clinically severe obese patients (class 3 obesity). Evidence suggests such procedures have greater effects on insulin secretion and insulin action than that expected from weight loss alone, which has led to the recent claim that such procedures may be useful as a primary treatment for T2DM in the moderately obese population. Concurrently, there have also been substantial advances in the non-surgical medical management of T2DM. As a result, the best treatment algorithm for T2DM patients with class 1 \& 2 obesity is increasingly controversial. This trial investigates the utility of currently practiced and available bariatric surgical procedures as compared with multidisciplinary intensive medical and weight management for the treatment of T2DM with class 1 and 2 obesity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes-mellitus
Started Jan 2010
Longer than P75 for not_applicable type-2-diabetes-mellitus
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 16, 2010
CompletedFirst Posted
Study publicly available on registry
February 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedResults Posted
Study results publicly available
May 6, 2021
CompletedJune 28, 2021
May 1, 2021
4.9 years
February 16, 2010
January 26, 2021
June 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fasting Plasma Glucose <126 mg/dL and HbA1c < 6.5% at Three Years of Follow-up.
The primary outcome variable of both parallel trials will be the percent of patients attaining glycemic control (defined as fasting plasma glucose \< 126 mg/dL and HbA1c \< 6.5%) at three years of follow-up.
3 years
Secondary Outcomes (3)
Glycemic Control, as Measured by Hemoglobin A1c
3 years
Body Mass Index
3 years
Cardiovascular Risk
3 years
Study Arms (2)
Gastric Band vs Intensive Diabetes & Weight Management
ACTIVE COMPARATORPatients will be randomized to receive either 1) laparoscopic placement of an adjustable gastric band (LAGB) or 2) treatment with an intensive medical and weight management (IMWM) program. LAGB will be placed using the "pars flaccida" technique. The Allergan laparoscopic band "LAP BAND" system will be utilized. LAGB ports will be placed in subcutaneous pockets in the right upper abdomen. The IMWM group will participate in the Weight Achievement and Intensive Treatment (Why WAIT) program, which is a multidisciplinary program for weight control and intensive diabetes management designed by Joslin Diabetes Center. Key aspects include: 1) Intensive and interactive medication adjustments, 2) Structured modified dietary intervention, 3) Graded, balanced, and individualized exercise intervention, 4) Cognitive behavioral intervention and 5) Group education.
RYGB vs Intensive Diabetes & Weight Management
ACTIVE COMPARATORPatients will be randomized to receive either 1) Roux-en-Y gastric bypass (RYGB) surgery or 2) treatment with an intensive medical and weight management (IMWM) program. RYGB will be performed using a 75 cm antecolic, ante-gastric Roux limb created with a 50 cm pancreaticobiliary limb. A 15-20 cc gastric pouch will be created lying along the lesser curve of the stomach, with division of the vagal trunks at the lower border of the pouch. The IMWM group will participate in the Weight Achievement and Intensive Treatment (Why WAIT) program, which is a multidisciplinary program for weight control and intensive diabetes management designed by Joslin Diabetes Center. Key aspects include: 1) Intensive and interactive medication adjustments, 2) Structured modified dietary intervention, 3) Graded, balanced, and individualized exercise intervention, 4) Cognitive behavioral intervention and 5) Group education.
Interventions
Intensive Medical Diabetes \& Weight Management (Why WAIT) - Band Group
Intensive Medical Diabetes \& Weight Management (Why WAIT) - Bypass Group
Eligibility Criteria
You may qualify if:
- Potential participants will be those with T2DM, with a diagnosis of diabetes of at least one year in duration,
- BMI 30-45 kg/m\^2 for the LAGB compared to intensive medical weight and diabetes management and BMI 30-42 kg/m\^2 for LRYGB compared to intensive medical weight and diabetes management,
- Age 21-65 years,
- With a strong desire for substantial weight loss, who are free from active cardiovascular or other diseases that would render them unable to partake in a structured exercise program or to undergo a bariatric surgical procedure, and who are committed to life long medical and nutritional follow up.
You may not qualify if:
- Detectable levels of glutamic acid decarboxylase (GAD) antibody or a history of diabetic ketoacidosis or uncontrolled T2DM (consistent fasting blood glucose \>200 mg/dl or HbA1c above twice normal);
- Previous gastrointestinal surgery, inflammatory bowel disease, esophageal diseases including severe intractable esophagitis, Barrett's Disease, esophageal dysmotility or other impaired gastric motility (gastroparesis), or hiatal hernia \>3 cm in size, chronic or acute bleeding conditions including peptic ulcer disease, portal hypertension (gastric or esophageal varices), chronic pancreatitis, or cirrhosis of the liver;
- Malignant or debilitating medical conditions, severe cardiopulmonary disease including uncontrolled hypertension (repeated systolic measures \>160 or diastolic \> 95 mm Hg on more than one day), unstable angina pectoris, recent myocardial infarction within 6 months, history of coronary artery bypass surgery or angioplasty, congestive heart failure, arrhythmia, stroke or transient ischemic attacks, urinary albumin excretion \>300 mcg/mg creatinine and/or serum creatinine \>1.5 mg/dL (permitting safety of increased dietary protein intake),
- Any endocrine disorder other than T2DM or thyroid disease which is stable on replacement therapy, including Cushing's syndrome;
- Any previous history of eating disorders, history of drug and/or alcohol abuse within 2 years of the screening visit, history of impaired mental status as defined by Diagnostic and Statistical Manual, 4th Edition (DSM-4) criteria and including, but not limited to active substance abuse, a history of schizophrenia, borderline personality disorder, uncontrolled depression, suicidal attempts within the past two years or current suicidal tendencies or ideations.
- Subjects will be excluded if there is a history of significant weight loss (\>3%) within the previous 3 months or participation in alternate medically supervised exercise or weight reduction program within the previous 3 months, or with use of prescription or over the counter weight reduction medications or supplements within one month of the Screening Visit and for the duration of study participation.
- Women who are lactating, planning pregnancy, or unwilling to use contraception during the course of the trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Joslin Diabetes Centerlead
- Brigham and Women's Hospitalcollaborator
Study Sites (2)
Brigham and Women's Hospital
Boston, Massachusetts, 02215, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Related Publications (8)
Lautz D, Halperin F, Goebel-Fabbri A, Goldfine AB. The great debate: medicine or surgery: what is best for the patient with type 2 diabetes? Diabetes Care. 2011 Mar;34(3):763-70. doi: 10.2337/dc10-1859. No abstract available.
PMID: 21357363BACKGROUNDHalperin F, Ding SA, Simonson DC, Panosian J, Goebel-Fabbri A, Wewalka M, Hamdy O, Abrahamson M, Clancy K, Foster K, Lautz D, Vernon A, Goldfine AB. Roux-en-Y gastric bypass surgery or lifestyle with intensive medical management in patients with type 2 diabetes: feasibility and 1-year results of a randomized clinical trial. JAMA Surg. 2014 Jul;149(7):716-26. doi: 10.1001/jamasurg.2014.514.
PMID: 24899464RESULTDing SA, Simonson DC, Wewalka M, Halperin F, Foster K, Goebel-Fabbri A, Hamdy O, Clancy K, Lautz D, Vernon A, Goldfine AB. Adjustable Gastric Band Surgery or Medical Management in Patients With Type 2 Diabetes: A Randomized Clinical Trial. J Clin Endocrinol Metab. 2015 Jul;100(7):2546-56. doi: 10.1210/jc.2015-1443. Epub 2015 Apr 24.
PMID: 25909333RESULTYu EW, Wewalka M, Ding SA, Simonson DC, Foster K, Holst JJ, Vernon A, Goldfine AB, Halperin F. Effects of Gastric Bypass and Gastric Banding on Bone Remodeling in Obese Patients With Type 2 Diabetes. J Clin Endocrinol Metab. 2016 Feb;101(2):714-22. doi: 10.1210/jc.2015-3437. Epub 2015 Nov 24.
PMID: 26600045RESULTPanosian J, Ding SA, Wewalka M, Simonson DC, Goebel-Fabbri A, Foster K, Halperin F, Vernon A, Goldfine AB. Physical Activity in Obese Type 2 Diabetes After Gastric Bypass or Medical Management. Am J Med. 2017 Jan;130(1):83-92. doi: 10.1016/j.amjmed.2016.07.019. Epub 2016 Aug 20.
PMID: 27555097RESULTSimonson DC, Halperin F, Foster K, Vernon A, Goldfine AB. Clinical and Patient-Centered Outcomes in Obese Patients With Type 2 Diabetes 3 Years After Randomization to Roux-en-Y Gastric Bypass Surgery Versus Intensive Lifestyle Management: The SLIMM-T2D Study. Diabetes Care. 2018 Apr;41(4):670-679. doi: 10.2337/dc17-0487. Epub 2018 Feb 6.
PMID: 29432125RESULTSimonson DC, Vernon A, Foster K, Halperin F, Patti ME, Goldfine AB. Adjustable gastric band surgery or medical management in patients with type 2 diabetes and obesity: three-year results of a randomized trial. Surg Obes Relat Dis. 2019 Dec;15(12):2052-2059. doi: 10.1016/j.soard.2019.03.038. Epub 2019 Apr 16.
PMID: 31931977RESULTDreyfuss JM, Yuchi Y, Dong X, Efthymiou V, Pan H, Simonson DC, Vernon A, Halperin F, Aryal P, Konkar A, Sebastian Y, Higgs BW, Grimsby J, Rondinone CM, Kasif S, Kahn BB, Foster K, Seeley R, Goldfine A, Djordjilovic V, Patti ME. High-throughput mediation analysis of human proteome and metabolome identifies mediators of post-bariatric surgical diabetes control. Nat Commun. 2021 Nov 29;12(1):6951. doi: 10.1038/s41467-021-27289-2.
PMID: 34845204DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Small sample size limits generalizability. Study performed at a single academic medical center. Duration of diabetes and insulin use, as proxies for β-cell function, were not inclusion or exclusion criteria. Long-term durability of beneficial effects of reducing weight and HbA1c could not be evaluated after 3 years. Newer bariatric surgical procedures, e.g. sleeve gastrectomy, were not studied.
Results Point of Contact
- Title
- Mary Elizabeth Patti MD
- Organization
- Joslin Diabetes Center
Study Officials
- PRINCIPAL INVESTIGATOR
Allison B. Goldfine, MD
Joslin Diabetes Center
- PRINCIPAL INVESTIGATOR
Ashley Vernon, MD
Brigham and Women's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2010
First Posted
February 22, 2010
Study Start
January 1, 2010
Primary Completion
December 1, 2014
Study Completion
November 1, 2016
Last Updated
June 28, 2021
Results First Posted
May 6, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share