The S.L.I.M.M.S. Procedure for Severe Clinical Obesity
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Weight Loss
Study Overview
Brief Summary
Assessment of Gastric Bypass combined with Vertical Sleeve Gastrectomy as primary treatment for patients with severe clinical obesity.
Average percentage of total weight loss and percentage excess weight loss will be computed at 6 months, one year and then annually. Comorbid conditions, quality of life measures, appetite and satiety measures and adverse events will be tracked.
Detailed Description
BACKGROUND
Metabolic Disease and Obesity
Obesity is one of the most common chronic diseases in America and is strongly associated with additional metabolic disorders, in particular hypertension, dyslipidemia and insulin resistance. The combination of obesity with this cluster of metabolic disorders increases risk for cardiovascular disease and is widely recognized by the term Metabolic Syndrome.
According to the Centers for Disease Control, in 2017-2018 the "prevalence of severe obesity among U.S. adults was 9.2%", the "age-adjusted prevalence of obesity in adults was 42.4%", and the prevalence of metabolic syndrome (MS) in the obese population is higher than 60%. The economic impact of metabolic syndrome is significant, with risk factors for MS shown to increase a person's annual healthcare costs by more than $2000.
Efforts to treat obesity and obesity-associated metabolic disease currently include medical management and surgical intervention. Success rates with surgical interventions exceed those of medical management but are dependent on patients making permanent changes in eating behaviors.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Be between 18 and 65 years of age
- •Have a body mass index of equal to or above 35 kgs per m2
- •Have identifiable obesity-related comorbidity; medical, physical or psycho-social
- •A history of attempts at weight reduction within the past five-year period
- •Ability to understand the non-surgical and surgical options for weight loss
- •Understand the behavioral changes needed to maximize surgical weight loss success
- •Agree to comply with recommended follow-up clinical assessments
- •Agree to comply with lifelong nutritional supplementation
Exclusion Criteria
- •Lack of ability to understand weight loss options and requirements for long-term success with surgery
- •Inability to understand and accept the risks and potential benefits
- •Inability to understand and agree to the compliance requirements of the study
- •Prior gastric surgery including all forms of bariatric surgical or endoscopic procedures
- •A history of previous abdominal surgery which precludes gastric bypass
- •Medical contra-indications to bariatric surgery
- •Dementia, active psychosis, unstable psychiatric disease
- •Concurrent experimental drug use
- •Pregnancy or intending to conceive within 12 months or current breast-feeding
- •Recreational drug use or excessive alcohol intake
- •Use of drugs known to affect body composition
- •Use of cytotoxic drugs
Arms & Interventions
S.L.I.M.M.S. Procedure
Prospective collection of data on the safety and efficacy of the S.L.I.M.M.S. Procedure
Intervention: S.L.I.M.M.S. Procedure (Procedure)
Outcomes
Primary Outcomes
Weight Loss
Time Frame: 6 months, 12 months and 2 years
Primary efficacy variable is Weight Loss Weight loss will be measured as: 1. Pounds lost (pre-op weight - post-op weight) 2. Total Weight Loss, calculated as (Pre-op Weight-Current Weight) in pounds (lb) 3. Percent Excess Weight Loss, calculated as \[(Pre-op Weight - Ideal Body Weight)/Ideal Body Weight\] x 100. Ideal Body Weight calculated using the universal IBW formula.
Secondary Outcomes
- Metabolic Comorbidity(2 Years)
- Changes in Quality of Life from baseline(2 Years)
- Adverse Events(2 Years)
Investigators
BRIAN B. QUEBBEMANN, M.D., F.A.C.S.
Director
The N.E.W. Program