The S.L.I.M.M.S. Procedure for Severe Clinical Obesity
SLIMMS
1 other identifier
interventional
200
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Typical duration for not_applicable
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
First Submitted
Initial submission to the registry
October 7, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedStudy Start
First participant enrolled
October 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedOctober 19, 2020
October 1, 2020
1.2 years
October 7, 2020
October 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight Loss
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.
6 months, 12 months and 2 years
Secondary Outcomes (3)
Metabolic Comorbidity
2 Years
Changes in Quality of Life from baseline
2 Years
Adverse Events
2 Years
Study Arms (1)
S.L.I.M.M.S. Procedure
EXPERIMENTALProspective collection of data on the safety and efficacy of the S.L.I.M.M.S. Procedure
Interventions
Combined Gastric Bypass with Vertical Sleeve Gastrectomy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The N.E.W. Program, Inc.
Newport Beach, California, 92663, United States
Foothill Regional Medical Center
Tustin, California, 92780, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
BRIAN QUEBBEMANN, M.D.
The N.E.W. Program, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
October 7, 2020
First Posted
October 19, 2020
Study Start
October 26, 2020
Primary Completion
December 31, 2021
Study Completion
December 31, 2022
Last Updated
October 19, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share