Weight Loss Via Bariatric Surgery and Lifestyle Modification

NCT ID: NCT05775172

Last Updated: 2023-03-20

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

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-09-10

Brief Summary

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Gastric myoelectric, inflammatory, and hormonal responses, body compositional, energy expenditure, and metabolic changes during the development of obesity and the weight loss process are underinvestigated. This project studied the myoelectrical inflammatory and hormonal responses of the stomach, in addition to energy expenditure and body composition changes during weight loss via bariatric surgery and lifestyle intervention.

Detailed Description

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Gastric myoelectric, inflammatory, and hormonal responses, body compositional, energy expenditure, and metabolic changes during the development of obesity and the weight loss process are underinvestigated. This project studied the myoelectrical, inflammatory, and hormonal responses of the stomach, in addition to energy expenditure and body composition changes during weight loss via bariatric surgery and lifestyle intervention.

Methods: We recruited 79 participants who were assigned to three groups: bariatric surgery (BS group n=27), lifestyle intervention (LS group, n=22), and waitlist control (C group n=30). For all participants, electrogastrography, inflammatory cytokines, gastric hormones analysis, body composition analysis, energy expenditure, and dietary assessment were done at baseline and at 6 months.

Conditions

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Obesity Weight Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Waitlist control

Waitlist control (C group n=30) did not achieve any significant weight loss and did not follow lifestyle intervention

Control

Intervention Type OTHER

No interventions were applied

Lifestyle intervention

Lifestyle intervention (LS group, n=22) follows multimodal lifestyle intervention in form of 500-100 kcal deficit , gradual physical activity and some behavioral modifications

Lifestyle intervention

Intervention Type DIETARY_SUPPLEMENT

balanced 500 to 1000-calorie-deficit diet, personalized physical activity plan, and customized behavioral modification

Bariatric surgery

Bariatric surgery (BS group n=27) undergoes laparoscopic sleeve gastrectomy

Sleeve gastrectomy

Intervention Type PROCEDURE

laparoscopic sleeve gastrectomy was done under general anesthesia by the same surgeon in the SBAHC. Routine preoperative, and postoperative care (including early post-operative dietary management) were done. Baseline assessment was taken within the last week before the surgery during the preoperative preparation and the final assessment was recorded 6 months after the surgery date.

Interventions

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Sleeve gastrectomy

laparoscopic sleeve gastrectomy was done under general anesthesia by the same surgeon in the SBAHC. Routine preoperative, and postoperative care (including early post-operative dietary management) were done. Baseline assessment was taken within the last week before the surgery during the preoperative preparation and the final assessment was recorded 6 months after the surgery date.

Intervention Type PROCEDURE

Lifestyle intervention

balanced 500 to 1000-calorie-deficit diet, personalized physical activity plan, and customized behavioral modification

Intervention Type DIETARY_SUPPLEMENT

Control

No interventions were applied

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* BMI \> 35 kg/m2,
* Being free of any acute medical condition, inflammatory conditions, malignancy, or psychiatric disorders

Exclusion Criteria

* Taking weight-losing pharmacotherapy
* Who underwent previous bariatric surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King AbdulAziz City for Science and Technology

OTHER

Sponsor Role collaborator

King Saud University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Abulmeaty, M.D., FACN.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahmoud Abulmeaty

Role: PRINCIPAL_INVESTIGATOR

King Saud University

Locations

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College of Applied Medical Sciences

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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BSvsLS

Identifier Type: -

Identifier Source: org_study_id

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