The S.L.I.M.M.S. Procedure for Severe Clinical Obesity (SLIMMS)

October 14, 2020 updated by: BRIAN B. QUEBBEMANN, M.D., F.A.C.S., The N.E.W. Program

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Commonly accepted surgical procedures have several mechanisms of action. These include decreased stomach volume restricting a patient's ability to eat, intestinal bypass resulting in significant malabsorption, and alterations in hormonal control of appetite and satiety. Standardized surgical procedures include Vertical Sleeve Gastrectomy (VSG), Roux-en-Y Gastric Bypass (GBP), Laparoscopic Gastric Banding (LB) and Biliopancreatic Diversion with Duodenal Switch (DS). Of these, VSG and GBP are the most commonly performed.

VSG and GBP have been shown to result in similar weight loss, however, both procedures have a significant long-term failure rate.

Key symptomatic differences between VSG and GBP

During the initial 6-12 months after surgery, both VSG and GBP patients typically report a marked decrease in appetite as well as a significant restriction in volume of food that can be eaten before "feeling full." This period of decreased appetite and early satiety is commonly referred to as the "honeymoon period." After this honeymoon period, every patient's weight loss success becomes progressively more dependent on changes made in their eating habits.

As would be expected with anatomically distinct procedures, patient symptoms begin to significantly differ over time. Patients that have undergone GBP, resulting in a gastric pouch that is less than 30cc report a more sustained feeling of restriction in the volume of food that can be eaten at a single meal compared to patients that have undergone VSG with a 100-150cc residual stomach. GBP patients also report a more persistent feeling of early satiety than do patients after VSG. In contrast, patients that have undergone VSG, with most of the Ghrelin-producing region of their stomach removed, report a more persistent decrease in appetite compared to patients after GBP, where the production of Ghrelin appears to rebound.

Key hormonal differences between VSG and GBP

VSG results in substantial and permanent decrease in the orexigenic hormone Ghrelin. After GBP, rebound of Ghrelin is shown to occur within 6 to 12 months after surgery.

GBP causes a significantly greater increase in postprandial GLP-1 and Peptide YY, possibly contributing to earlier satiety and improved glycemic control.

Key differences in side effects between VSG and GBP

A common side effect of VSG is GERD. When symptoms are severe, conversion to GBP provides relief.

Dumping syndrome, a side effect of GBP, is often described as an effective negative feedback mechanism, helping to minimize ingestion of high glycemic index foods. Dumping is not typically associated with VSG.

Considering these differences, it is reasonable to question whether a single-stage procedure that combines the anatomic changes of both the GBP and VSG would result in;

  1. Improved weight loss
  2. An improved quality of life
  3. Better glycemic control

PROPOSED STUDY

Surgical Intervention

The S.L.I.M.M.S. Procedure, for Surgically Limit Intake and Manage Metabolic Syndrome, is a single-stage operation combining Roux-en-Y Gastric Bypass with Partial Gastrectomy. The procedure specifications are listed below,

  1. A 20 cc gastric pouch
  2. A 10 mm diameter gastro-jejunal stoma
  3. A 40 cm biliopancreatic limb (measured from the Ligament of Treitz)
  4. A 150 cm roux limb
  5. Resection of the remaining fundus and body of the stomach, maintaining the majority of the gastric antrum
  6. Oversewing the gastric staple lines and buttressing with omentum

Most new procedures focus on variations of intestinal reconstruction, or involve implantation of artificial devices. The proposed procedure does not require implantation of an artificial device, nor a new method of intestinal reconstruction. It simply combines the two most common bariatric procedures in the world with the hope of providing cumulative benefits without increased risk.

Key Technical and Anatomic Precedents

  1. When VSG results in severe and recalcitrant GERD the standard treatment is conversion to GBP. The final anatomic result is a patient with a gastric bypass and the majority of the gastric fundus and body removed. This is similar to the final anatomy of the procedure proposed in this study, however, the S.L.I.M.M.S. procedure will be done as a single operation.
  2. In several centers, resectional gastric bypass, involving a standard gastric bypass combined with a subtotal or total gastrectomy, is performed routinely [24-28]. Published reports from these centers do not demonstrate increased complications.

Significance of this Study

Currently accepted surgical procedures all have significant long-term failure rates or frequently result in substantial malnutrition. Multiple new and novel surgical procedures are currently being tried that focus either on simple restriction or on increasing malabsorption. These new procedures are not designed with the intention of providing increased, permanent support for the patient's behavioral changes which are so critical in the long-term success of all bariatric surgery. The S.L.I.M.M.S. procedure is designed with the primary goal of a more sustained appetite suppression and increased early satiety.

Aims of This Study

The specific aim of the study is to assess the safety and efficacy of the S.L.I.M.M.S. Procedure as a stand-alone, single-stage bariatric operation.

METHODS

Trial Protocol

  1. Patient Recruitment

    a. Recruitment into the study will be achieved by a physician awareness campaign using direct mail. An Internet awareness campaign will target potential patients. Announcements will include description of planned procedure, aim of study and experimental nature of the S.L.I.M.M.S. Procedure.

  2. Patient Education

    a. Patient Education consisting of i. Detailed Consultation ii. Patient Education Packet iii. Written Examination iv. Education on pre- and post-operative dietary protocols v. Mandatory Dietary Rebuild counselling program vi. Permanent Surgical Weight Loss book provided vii. DietaryRebuild™ book provided viii. Exercise Instructions ix. Nutrition Supplementation Instructions

  3. Patient Enrolment

    a. Enrolment into the study will be proceeded by patient education including a detailed discussion of the nature of this clinical trial. A detailed consent will also be provided.

  4. Pre-trial Assessment

    1. Initial clinical assessment will include a detailed dietary history and a review for co-morbidities of obesity.
    2. Assessment of nutrition knowledge and quality of life will be obtained using the General Nutrition Knowledge Questionnaire, the Bariatric Quality of Life Index and the SF-36/Rand.
    3. Clinical assessment will include various weight parameters and measurement of serum glucose, hemoglobin A1c, lipids, vitamin levels, iron, ferritin, RBC folate, complete blood count, comprehensive metabolic profile, and abdominal ultrasound.
  5. Surgery: S.L.I.M.M.S. Procedure

  6. Patient Support

    1. In-clinic follow up
    2. Support groups offered
    3. Telephone-based group counselling sessions

  7. Post-operative Assessment

    1. Weight Parameters measured at 6 months, 12 months and annually
    2. Laboratory assessment will include serum glucose, hemoglobin A1c, lipids, vitamin levels, iron, ferritin, RBC folate, complete blood count, comprehensive metabolic profile and lipid profile at 6 months, 12 months and annually thereafter
    3. Quality of life measure at 1, 12 and 24 months; Bariatric Quality of Life Index and SF-36/Rand

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Newport Beach, California, United States, 92663
        • The N.E.W. Program, Inc.
      • Tustin, California, United States, 92780
        • Foothill Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Be between 18 and 65 years of age
  2. Have a body mass index of equal to or above 35 kgs per m2
  3. Have identifiable obesity-related comorbidity; medical, physical or psycho-social
  4. A history of attempts at weight reduction within the past five-year period
  5. Ability to understand the non-surgical and surgical options for weight loss
  6. Understand the behavioral changes needed to maximize surgical weight loss success
  7. Agree to comply with recommended follow-up clinical assessments
  8. Agree to comply with lifelong nutritional supplementation

Exclusion Criteria:

  1. Lack of ability to understand weight loss options and requirements for long-term success with surgery
  2. Inability to understand and accept the risks and potential benefits
  3. Inability to understand and agree to the compliance requirements of the study
  4. Prior gastric surgery including all forms of bariatric surgical or endoscopic procedures
  5. A history of previous abdominal surgery which precludes gastric bypass
  6. Medical contra-indications to bariatric surgery
  7. Dementia, active psychosis, unstable psychiatric disease
  8. Concurrent experimental drug use
  9. Pregnancy or intending to conceive within 12 months or current breast-feeding
  10. Recreational drug use or excessive alcohol intake
  11. Use of drugs known to affect body composition
  12. Use of cytotoxic drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Procedure: S.L.I.M.M.S. Procedure
Combined Gastric Bypass with Vertical Sleeve Gastrectomy
Other Names:
  • Bariatric Surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months, 12 months and 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Metabolic Comorbidity
Time Frame: 2 Years
Glycemic control will be a specifically targeted endpoint. Serum glucose, HbA1c and documenting current diabetic medication regimen.
2 Years
Changes in Quality of Life from baseline
Time Frame: 2 Years
Quality of life measured using Bariatric Quality of Life Index and SF-36/Rand
2 Years
Adverse Events
Time Frame: 2 Years
Surgical complications are reported by participants and observed by the investigator and clinical trial staff, then reported on appropriate adverse event tracking forms
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The N.E.W. Program

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: BRIAN QUEBBEMANN, M.D., The N.E.W. Program, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SLIMMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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