What is the mechanism of action of this treatment?

Weight loss treatments, such as bariatric surgery, primarily work by reducing the stomach size or altering the digestive process to limit food intake and nutrient absorption. Procedures like gastric bypass or sleeve gastrectomy reduce the stomach's capacity, making patients feel full sooner and thus consume fewer calories. Additionally, these surgeries can alter gut hormones, which play a role in hunger and satiety, further aiding in weight loss. These mechanisms are crucial for weight loss patients as they not only help in significant weight reduction but also improve obesity-related comorbidities, enhancing overall health and quality of life.

What side effects are associated with this type of intervention?

Common treatments for weight loss, particularly bariatric surgery, include procedures like gastric bypass, sleeve gastrectomy, and adjustable gastric banding. These surgeries can lead to significant weight loss but also come with potential side effects. Common side effects include nutritional deficiencies (such as vitamin B12, iron, calcium, and vitamin D), dumping syndrome (rapid gastric emptying causing nausea, vomiting, diarrhea, and dizziness), and surgical complications like infections, blood clots, and leaks in the gastrointestinal tract. Long-term risks may include bowel obstruction, hernias, and gallstones. It is crucial for patients to have regular follow-ups and nutritional monitoring post-surgery.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for weight loss, including GLP-1 receptor agonists like semaglutide and liraglutide, which help reduce appetite and increase satiety. Additionally, combination drugs such as phentermine-topiramate have been approved for their efficacy in promoting weight loss. Surgical interventions like gastric bypass and sleeve gastrectomy, which reduce stomach size and alter nutrient absorption, have also been approved and are commonly used for significant and sustained weight loss in patients with severe obesity.

What other types of research exist?

Promising, novel alternatives to weight loss surgery for 2024 include: 1) Pharmacological treatments such as GLP-1 receptor agonists (e.g., semaglutide) which have shown significant weight loss results. 2) Endoscopic procedures like endoscopic sleeve gastroplasty (ESG) that reduce stomach size without surgery. 3) Advanced lifestyle interventions supported by digital health technologies, including personalized diet and exercise programs monitored through mobile apps and wearable devices.

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Bariatric Surgery

Weight Loss Surgery Outcomes for Obesity

N/A

Recruiting

Led By Michael Feizbakhsh, MD

Research Sponsored by Dr. Feiz & Associates

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 1, 3, 6, 12 months

Awards & highlights

Summary

This trial studies the effects of weight loss surgery on patients who do not have other weight-related health problems. The surgery helps people lose weight by making their stomach smaller or changing how their body digests food. Researchers want to see how this surgery affects their health, mood, quality of life, and emotional well-being.

Who is the study for?

This trial is for individuals with a BMI between 30 and 34.5 who are healthy enough for cosmetic weight loss surgery but don't have other health issues like diabetes or high blood pressure. Participants must be able to give informed consent and follow study procedures.

What is being tested?

The study aims to assess patient-reported outcomes after weight loss surgery in low-risk patients, focusing on changes in health, mood, quality of life, satisfaction with their health status, and emotional well-being.

What are the potential side effects?

Since the intervention involves questionnaires about body image and self-esteem rather than medical treatments, there are no direct physical side effects from participating in this trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 1, 3, 6, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 1, 3, 6, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 1, 3, 6, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Perception of Body Image

Change in Perception of General Health

Change in Perception of Quality of Life

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients with BMI between 30-34.5 kg/m2Experimental Treatment1 Intervention

Patients with BMI between 30-34.5 kg/m2 will be administered a body image/self-esteem questionnaire pre-operatively and at 1 month, 3 months, 6 months and 12 months post-operatively.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Weight loss treatments, such as bariatric surgery, primarily work by reducing the stomach size or altering the digestive process to limit food intake and nutrient absorption. Procedures like gastric bypass or sleeve gastrectomy reduce the stomach's capacity, making patients feel full sooner and thus consume fewer calories. Additionally, these surgeries can alter gut hormones, which play a role in hunger and satiety, further aiding in weight loss. These mechanisms are crucial for weight loss patients as they not only help in significant weight reduction but also improve obesity-related comorbidities, enhancing overall health and quality of life.

The Problem of Appetite Loss After Major Abdominal Surgery: A Systematic Review.Pharmacokinetic changes post-bariatric surgery: A scoping review.Do postoperative psychotherapeutic interventions and support groups influence weight loss following bariatric surgery? A systematic review and meta-analysis of randomized and nonrandomized trials.

Find a Location

Who is running the clinical trial?

Dr. Feiz & AssociatesLead Sponsor

Michael Feizbakhsh, MDPrincipal InvestigatorDr. Feiz and Associates

Media Library

Weight Loss Surgery (Bariatric Surgery) Clinical Trial Eligibility Overview. Trial Name: NCT05699083 — N/A

Weight Loss Research Study Groups: Patients with BMI between 30-34.5 kg/m2

Weight Loss Clinical Trial 2023: Weight Loss Surgery Highlights & Side Effects. Trial Name: NCT05699083 — N/A

Weight Loss Surgery (Bariatric Surgery) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05699083 — N/A

Weight Loss Patient Testimony for trial: Trial Name: NCT05699083 — N/A

~2 spots leftby Jan 2025

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