Weight Loss Via Bariatric Surgery and Lifestyle Modification

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05775172
• Other study ID #: BSvsLS
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: September 10, 2022

Study information

• Verified date: March 2023
• Source: King Saud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: September 10, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Weight Loss

Intervention

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.

Dietary Supplement:
• Lifestyle intervention
balanced 500 to 1000-calorie-deficit diet, personalized physical activity plan, and customized behavioral modification

Other:
• Control
No interventions were applied

Locations

Country	Name	City	State
Saudi Arabia	College of Applied Medical Sciences	Riyadh

Sponsors (2)

Lead Sponsor	Collaborator
King Saud University	King AbdulAziz City for Science and Technology

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric myoelectric activity	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
Primary	Inflammatory changes	Serum levels of inflammatory markers involving interleukin-6 (IL-6), tumor necrosis factor-a (TNF-a), C-reactive protein (CRP), and monocyte chemoattractant protein (MCP-1),	6 months
Primary	Body composition measurement	Body composition was analyzed via a multi-Frequency segmental bioelectric impedance analysis monitor	6 MONTHS
Primary	Resting Energy Expenditure	Resting metabolic rate (RMR) was measured by the automated metabolic cart indirect calorimetry (IC) using a standard canopy hood	6 MONTHS
Primary	hormonal analysis	serum levels of ghrelin, gastrin, and irisin (ELISA kits MyBiosource, San Diego, CA, USA; Catalog numbers: MBS2700428, MBS264399, MBS2600406, respectively).	6 Months