Weight Loss Via Bariatric Surgery and Lifestyle Modification

• Sponsor: King Saud University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05775172
• Collaborator: King AbdulAziz City for Science and Technology (Other)
• Enrollment: 79
• Location: 1
• Actual Duration (Months): 15.3
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Weight Loss	Procedure: Sleeve gastrectomy; Dietary Supplement: Lifestyle intervention; Other: Control

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 79 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Gastric Myoelectric Activity, Inflammatory, Dietary, and Body Composition Changes During Weight Loss Via Bariatric Surgery and Lifestyle Modification
• Actual Study Start Date: Jun 1, 2021
• Actual Primary Completion Date: Jun 30, 2022
• Actual Study Completion Date: Sep 10, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Gastric myoelectric activity [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

2. Inflammatory changes [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),

3. Body composition measurement [6 MONTHS]

   Body composition was analyzed via a multi-Frequency segmental bioelectric impedance analysis monitor

4. Resting Energy Expenditure [6 MONTHS]

   Resting metabolic rate (RMR) was measured by the automated metabolic cart indirect calorimetry (IC) using a standard canopy hood

5. hormonal analysis [6 Months]

   serum levels of ghrelin, gastrin, and irisin (ELISA kits MyBiosource, San Diego, CA, USA; Catalog numbers: MBS2700428, MBS264399, MBS2600406, respectively).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	College of Applied Medical Sciences	Riyadh		Saudi Arabia	11433

Sponsors and Collaborators

• King Saud University
• King AbdulAziz City for Science and Technology

Investigators

• Principal Investigator: Mahmoud Abulmeaty, King Saud University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mahmoud Abulmeaty, M.D., FACN., Professor, King Saud University
• ClinicalTrials.gov Identifier: NCT05775172
• Other Study ID Numbers: BSvsLS
• First Posted: Mar 20, 2023
• Last Update Posted: Mar 20, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Mahmoud Abulmeaty, M.D., FACN., Professor, King Saud University: gastric myoelectric activity; Inflammatory; bariatric surgery; lifestyle intervention; weight loss; body composition
• Additional relevant MeSH terms: Body Weight; Weight Loss

Study Results

No Results Posted as of Mar 20, 2023