Weight Loss Via Bariatric Surgery and Lifestyle Modification

NCT05775172 | Completed DMC

• 1 other identifier: BSvsLS
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Weight Loss

Keywords

gastric myoelectric activity; Inflammatory; bariatric surgery; lifestyle intervention; weight loss; body composition

Outcome Measures

Primary Outcomes (5)

• 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

• Inflammatory changes

  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),

  6 months

• Body composition measurement

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

  6 MONTHS

• Resting Energy Expenditure

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

  6 MONTHS

• hormonal analysis

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

  6 Months

Study Arms (3)

Waitlist control

Waitlist control (C group n=30) did not achieve any significant weight loss and did not follow lifestyle intervention

Other: Control

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

Bariatric surgery

Bariatric surgery (BS group n=27) undergoes laparoscopic sleeve gastrectomy

Procedure: Sleeve gastrectomy

Interventions

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.

Bariatric surgery

Lifestyle intervention DIETARY_SUPPLEMENT

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

Lifestyle intervention

Control OTHER

No interventions were applied

Waitlist control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• BMI \> 35 kg/m2,
• Being free of any acute medical condition, inflammatory conditions, malignancy, or psychiatric disorders

You may not qualify if:

• Taking weight-losing pharmacotherapy
• Who underwent previous bariatric surgery

Sponsors & Collaborators

• King Saud University: lead
• King AbdulAziz City for Science and Technology: collaborator

Study Sites (1)

College of Applied Medical Sciences

Riyadh, 11433, Saudi Arabia

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Mahmoud Abulmeaty

  King Saud University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 20, 2023
• Study Start: June 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: September 10, 2022
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)