ObesityNCT05775172
Weight Loss Via Bariatric Surgery and Lifestyle Modification
An observational study of Obesity and Weight Loss, run by King Saud University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- Sleeve gastrectomy and Lifestyle intervention
- Type of treatment
- Surgery or procedure
- How many people
- 79 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jun 2021to 10 Sep 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- BMI > 35 kg/m2,
- Being free of any acute medical condition, inflammatory conditions, malignancy, or psychiatric disorders
Who cannot join
- Taking weight-losing pharmacotherapy
- Who underwent previous bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gastric Myoelectric Activity, Inflammatory, Dietary, and Body Composition Changes During 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.
Read the 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.
- Conditions
- Obesity, Weight Loss
- Being tested
- Sleeve gastrectomy, Lifestyle intervention, Control
- Keywords
- gastric myoelectric activity, Inflammatory, bariatric surgery, lifestyle intervention, weight loss, body composition
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve gastrectomyProcedure or surgery
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 interventionDietary supplement
balanced 500 to 1000-calorie-deficit diet, personalized physical activity plan, and customized behavioral modification
ControlOther
No interventions were applied
| Study group | Role | What they receive |
|---|---|---|
| Waitlist control | Waitlist control (C group n=30) did not achieve any significant weight loss and did not follow lifestyle intervention Receives: 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 Receives: Dietary Supplement: Lifestyle intervention | |
| Bariatric surgery | Bariatric surgery (BS group n=27) undergoes laparoscopic sleeve gastrectomy Receives: Procedure: Sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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),
Measured: 6 months
Body composition measurement
Body composition was analyzed via a multi-Frequency segmental bioelectric impedance analysis monitor
Measured: 6 MONTHS
Resting Energy Expenditure
Resting metabolic rate (RMR) was measured by the automated metabolic cart indirect calorimetry (IC) using a standard canopy hood
Measured: 6 MONTHS
hormonal analysis
serum levels of ghrelin, gastrin, and irisin (ELISA kits MyBiosource, San Diego, CA, USA; Catalog numbers: MBS2700428, MBS264399, MBS2600406, respectively).
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start1 Jun 2021
- Primary completion30 Jun 2022
- Study completion10 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Collaborators
- King AbdulAziz City for Science and Technology
- Responsible party
- Principal investigator, Mahmoud Abulmeaty, M.D., FACN., King Saud University
- Investigators
- Mahmoud Abulmeaty, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775172
- Sponsor's protocol ID
- BSvsLS
- Status last verified
- Mar 2023
- First submitted
- 3 Mar 2023
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Myoelectric Activity, Inflammatory, Dietary, and Body Composition Changes During Weight Loss Via Bariatric Surgery and Lifestyle Modification
- ClinicalTrials.gov ID
- NCT05775172
- Acronym / sponsor ID
- BSvsLS
- Conditions
- Obesity, Weight Loss
- Keywords
- gastric myoelectric activity, Inflammatory, bariatric surgery, lifestyle intervention, weight loss, body composition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Collaborators
- King AbdulAziz City for Science and Technology
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 10 Sep 2022 (actual)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Waitlist control | – | Other: ControlWaitlist control (C group n=30) did not achieve any significant weight loss and did not follow lifestyle intervention |
| Lifestyle intervention | – | Dietary Supplement: Lifestyle interventionLifestyle intervention (LS group, n=22) follows multimodal lifestyle intervention in form of 500-100 kcal deficit , gradual physical activity and some behavioral modifications |
| Bariatric surgery | – | Procedure: Sleeve gastrectomyBariatric surgery (BS group n=27) undergoes laparoscopic sleeve gastrectomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- BMI > 35 kg/m2,
- Being free of any acute medical condition, inflammatory conditions, malignancy, or psychiatric disorders
Key exclusion criteria (2 listed)
- Taking weight-losing pharmacotherapy
- Who underwent previous bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleeve gastrectomylaparoscopic 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. | Procedure or surgery | Bariatric surgery |
| Lifestyle interventionbalanced 500 to 1000-calorie-deficit diet, personalized physical activity plan, and customized behavioral modification | Dietary supplement | Lifestyle intervention |
| ControlNo interventions were applied | Other | Waitlist control |
Primary outcome
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
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),
Body composition measurement
Time frame: 6 MONTHS
Body composition was analyzed via a multi-Frequency segmental bioelectric impedance analysis monitor
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
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Abulmeaty principal investigator
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Weight Loss, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric myoelectric activity (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.