Clinical trial NCT05775172: Weight Loss Via Bariatric Surgery and Lifestyle Modification
Official title: Gastric Myoelectric Activity, Inflammatory, Dietary, and Body Composition Changes During Weight Loss Via Bariatric Surgery and Lifestyle Modification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Weight Loss
Keywords: gastric myoelectric activity
Inflammatory
bariatric surgery
lifestyle intervention
weight loss
body composition
Lead sponsor: King Saud University
Sponsor class: OTHER
Collaborators: name: King AbdulAziz City for Science and Technology
First posted: 2023-03-20
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gastric myoelectric activity
timeFrame: 6 months
measure: Inflammatory changes
timeFrame: 6 months
measure: Body composition measurement
timeFrame: 6 MONTHS
measure: Resting Energy Expenditure
timeFrame: 6 MONTHS
measure: hormonal analysis
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: College of Applied Medical Sciences
Study officials:
affiliation: King Saud University
name: Mahmoud Abulmeaty
role: PRINCIPAL_INVESTIGATOR
References: