Weight Loss Via Bariatric Surgery and Lifestyle Modification

Completed

• Conditions: Weight Loss; Obesity
• Interventions: Dietary Supplement: Lifestyle intervention; Other: Control; Procedure: Sleeve gastrectomy

• Registration Number: NCT05775172
• Lead Sponsor: King Saud University

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.

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 Timeline

• Study Start: 2021-06-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-09-10
• Status Verified: 2023-03
• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-07
• Last Update Submitted: 2023-03-07
• Study First Posted: 2023-03-20
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lifestyle intervention	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
Waitlist control	Control	Waitlist control (C group n=30) did not achieve any significant weight loss and did not follow lifestyle intervention
Bariatric surgery	Sleeve gastrectomy	Bariatric surgery (BS group n=27) undergoes laparoscopic sleeve gastrectomy

Primary Outcome Measures

Name	Time	Method
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
Resting Energy Expenditure	6 MONTHS	Resting metabolic rate (RMR) was measured by the automated metabolic cart indirect calorimetry (IC) using a standard canopy hood
Body composition measurement	6 MONTHS	Body composition was analyzed via a multi-Frequency segmental bioelectric impedance analysis monitor
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),
hormonal analysis	6 Months	serum levels of ghrelin, gastrin, and irisin (ELISA kits MyBiosource, San Diego, CA, USA; Catalog numbers: MBS2700428, MBS264399, MBS2600406, respectively).

Trial Locations

Locations (1)

College of Applied Medical Sciences; 🇸🇦 Riyadh, Saudi Arabia