Weight Loss Via Bariatric Surgery and Lifestyle Modification

March 7, 2023 updated by: Mahmoud Abulmeaty, M.D., FACN., King Saud University

Gastric Myoelectric Activity, Inflammatory, Dietary, and Body Composition Changes During Weight Loss Via Bariatric Surgery and Lifestyle Modification

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

79

Contacts and Locations

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

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11433
        • College of Applied Medical Sciences

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

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

A total of 79 participants were randomly assigned to three groups: bariatric surgery (BS group n=27), lifestyle intervention (LS group, n=22), and waitlist control (C group n=30). The participants in the three groups were similar in BMI (>35 kg/m2), age (18-40 years), and gender. Inclusion criteria included BMI > 35 kg/m2, and being free of any acute medical condition, malignancy, or psychiatric disorders. Participants taking weight-losing pharmacotherapy or who underwent previous bariatric surgery were excluded. For all participants, electrogastrography, inflammatory cytokines measurements, body composition analysis, dietary assessment, and indirect calorimetry (as described in objective 1) were done at baseline, and after 6 months.

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Waitlist control
Waitlist control (C group n=30) did not achieve any significant weight loss and did not follow lifestyle intervention
Other: Control
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
Dietary supplement: Lifestyle intervention
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
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric myoelectric activity
Time Frame: 6 months
The gastric myoelectric activity was measured in fasting (for 10 mins) and post-prandial state (for 30 mins) using a multichannel electrogastrography (EGG) with a water load satiety test
6 months
Inflammatory changes
Time Frame: 6 months
Serum levels of inflammatory markers involving interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), and monocyte chemoattractant protein (MCP-1),
6 months
Body composition measurement
Time Frame: 6 MONTHS
Body composition was analyzed via a multi-Frequency segmental bioelectric impedance analysis monitor
6 MONTHS
Resting Energy Expenditure
Time Frame: 6 MONTHS
Resting metabolic rate (RMR) was measured by the automated metabolic cart indirect calorimetry (IC) using a standard canopy hood
6 MONTHS
hormonal analysis
Time Frame: 6 Months
serum levels of ghrelin, gastrin, and irisin (ELISA kits MyBiosource, San Diego, CA, USA; Catalog numbers: MBS2700428, MBS264399, MBS2600406, respectively).
6 Months

Collaborators and Investigators

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

Sponsor

King Saud University

Collaborators

King AbdulAziz City for Science and Technology

Investigators

  • Principal Investigator: Mahmoud Abulmeaty, King Saud University

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 (Actual)

June 1, 2021

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

September 10, 2022

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

March 7, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 7, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSvsLS

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

product manufactured in and exported from the U.S.

Yes

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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