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Completed

NCT Number: NCT05775172

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

College of Applied Medical Sciences

Riyadh, 11433, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleeve gastrectomy

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.

Lifestyle intervention

Dietary Supplement

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

Control

Other

No interventions were applied

Primary outcomes

  1. 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

  2. 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),

  3. Body composition measurement

    Time frame: 6 MONTHS

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

  4. 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

  5. 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).

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Collaborators

  • King AbdulAziz City for Science and Technology

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 20, 2023
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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