Outcomes After Weight Loss Surgery in Low-Risk Patients

NCT ID: NCT05699083

Last Updated: 2023-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-11

Study Completion Date

2026-01-12

Brief Summary

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The purpose of this research is to determine patient-reported outcomes after weight loss surgery, including changes in health, mood, quality of life, health satisfaction, and emotional health, in low-risk patients. Weight loss surgery has been well studied for patients with body mass index (BMI) 35 kg/m\^2 or more and those with weight-related medical problems who have a BMI 30 kg/m\^2 or more. However, outcomes after weight loss surgery in patients with BMI under 35 kg/m\^2 and without co-morbidities have not been well studied.

Detailed Description

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The purpose of this research is to determine patient-reported outcomes after weight loss surgery in low-risk patients. Weight loss surgery has been well-studied for patients with body mass index (BMI) 35 kg/m\^2 or more and those with weight-related medical problems who have a BMI 30 kg/m\^2 or more. Weight-related medical problems, also called co-morbidities, can include diabetes mellitus, hypertension, sleep apnea, and degenerative joint diseases. The surgery is considered safe and effective. Outcomes after weight loss surgery in patients with BMI under 35 kg/m\^2 and without co-morbidities have not been well studied. The investigators' purpose is to study patient-reported outcomes after weight loss surgery in patients with BMI between 30 kg/m\^2 and 34.5 kg/m\^2 without co-morbidities. These include changes in health, mood, quality of life, health satisfaction, and emotional health.

Conditions

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Weight Loss Bariatric Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pre-post interventional study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients with BMI between 30-34.5 kg/m2

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.

Group Type OTHER

Body Image/Self-Esteem Questionnaires

Intervention Type OTHER

Pre-operation and post-operation questionnaires to assess factors including but not limited to body image, quality of life, and self-esteem.

Interventions

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Body Image/Self-Esteem Questionnaires

Pre-operation and post-operation questionnaires to assess factors including but not limited to body image, quality of life, and self-esteem.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with BMI between 30 kg/m2 and 34.5 kg/m2 without co-morbidities who are medically cleared to undergo cosmetic weight loss surgery.
* Written informed consent obtained from the subject or the subject's legal representative and the ability for the subject to comply with the requirements of the study.

Exclusion Criteria

* Patients who are pregnant.
* Patients with BMI below 30 kg/m2.
* Patients with BMI above 34.5 kg/m2.
* Patients who have co-morbidities including, but not limited to, diabetes mellitus, hypertension, sleep apnea, and degenerative joint disease.
* Patients who are not medically cleared to undergo weight loss surgery.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Feiz & Associates

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Feizbakhsh, MD

Role: PRINCIPAL_INVESTIGATOR

Dr. Feiz and Associates

Locations

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Dr. Feiz and Associates

Beverly Hills, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Negin Fadaee, BS MPH

Role: CONTACT

818-326-5515

Facility Contacts

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Negin Fadaee, BS MPH

Role: primary

818-326-5515

Other Identifiers

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MF001

Identifier Type: -

Identifier Source: org_study_id

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