The S.L.I.M.M.S. Procedure for Severe Clinical Obesity

Status unconfirmed · Not applicable

Conditions studied: Morbid Obesity, Metabolic Syndrome, Type2 Diabetes, Insulin Resistance

In brief

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.

Key facts

Study ID

NCT04592601

Run by

The N.E.W. Program

People needed

200

Starts

2020-10-26

Expected to finish

2022-12-31

Last updated by the study team

2020-10-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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