Laparascopic Sleeve GastrectomyNCT07437716
Impact Of Laparoscopic Sleeve Gastrectomy On Obesity-Related Comorbidities In Patients Over 65 Years
A study testing Laparoscopic Sleeve Gastrectomy (LSG) and Structured Dietary Counseling in people with Laparascopic Sleeve Gastrectomy and Obesity & Overweight, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This study compares laparoscopic sleeve gastrectomy (a type of weight-loss surgery) with non-surgical care in adults aged 65 or older who have severe obesity and related health problems like type 2 diabetes, high blood pressure, knee joint issues from osteoarthritis, or sleep apnea. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Laparascopic Sleeve Gastrectomy, Obesity & Overweight, Obesity Type 2 Diabetes Mellitus
- What is being tested?
- Laparoscopic Sleeve Gastrectomy (LSG) and Structured Dietary Counseling
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Sep 2025
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥65 years
- Body Mass Index (BMI) ≥40 kg/m²
- Presence of at least one weight-related comorbidity: type 2 diabetes mellitus (T2D), hypertension (HTN), obstructive sleep apnea (OSA), or osteoarthritis (OA)
- Ability to provide informed consent and complete 12-month follow-up protocol
Who cannot join
- Severe cardiopulmonary disease preventing surgery or follow-up
- Active malignancy
- Uncontrolled psychiatric illness
- Inability to comply with follow-up visits
- Previous abdominal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact Of Laparoscopic Sleeve Gastrectomy On Obesity-Related Comorbidities In Patients Over 65 Years: A Prospective Comparative Study
This study compares laparoscopic sleeve gastrectomy (a type of weight-loss surgery) with non-surgical care in adults aged 65 or older who have severe obesity and related health problems like type 2 diabetes, high blood pressure, knee joint issues from osteoarthritis, or sleep apnea. Over 12 months, 60 patients chose either surgery or diet counseling with medications for their conditions (30 in each group). The main goals are to measure improvements in these health issues, weight loss, and safety.
Why This Study Matters Severe obesity in older adults raises risks for serious health conditions that diet and medications often fail to fix long-term. Surgery like sleeve gastrectomy removes part of the stomach to limit food intake and improve hormones that control hunger and blood sugar, but its benefits need direct proof against usual care in seniors.
What Happens in the Study Patients picked their treatment: surgery group got the procedure plus routine care; non-surgery group got nutrition advice and standard drugs. Doctors tracked weight, blood tests, blood pressure, sleep studies, knee X-rays, drug needs, and side effects at 1, 3, 6, and 12 months.
- Conditions
- Laparascopic Sleeve Gastrectomy, Obesity & Overweight, Obesity Type 2 Diabetes Mellitus, Obstructive Sleep Apnea (OSA), Hypertension (HTN), Osteo Arthritis of the Knee
- Being tested
- Laparoscopic Sleeve Gastrectomy (LSG), Structured Dietary Counseling
- Keywords
- Obesity, Sleeve Gastrectomy, Type 2 Diabetes, Hypertension, Comorbidities, Bariatric Surgery, Obstructive Sleep Apnea, Osteoarthritis
- Medical subject headings
- Obesity, Overweight, Sleep Apnea, Obstructive, Hypertension, Diabetes Mellitus, Type 2, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Sleeve Gastrectomy (LSG)Procedure or surgery
Laparoscopic sleeve gastrectomy performed under general anesthesia using 5 trocars (baseball diamond technique), liver retraction (Nathanson), Ligasure dissection of greater curvature/short gastrics, 34-French bougie calibration along lesser curvature, sequential linear stapling (60-mm, 4-5 firings) from 4-6 cm proximal to pylorus to angle of His, staple line reinforcement optional, resected stomach removed via port, methylene blue leak test, and routine VTE prophylaxis (enoxaparin 40 mg SC daily ×10 days + sequential compression devices).
Structured Dietary CounselingBehavioural
Structured dietary counseling providing a 500-800 kcal daily deficit, delivered by certified nutritionists, combined with guideline-directed pharmacotherapy for weight-related comorbidities (type 2 diabetes, hypertension, osteoarthritis, obstructive sleep apnea) in specialized clinics. No anti-obesity pharmacotherapy (e.g., GLP-1 receptor agonists) due to high cost and lack of insurance coverage, per patient preference
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Sleeve Gastrectomy (LSG) | Experimental | Patients aged ≥65 years with BMI ≥40 kg/m² and ≥1 weight-related comorbidity underwent laparoscopic sleeve gastrectomy (LSG) under general anesthesia using the baseball diamond trocar technique, 34-Fr bougie calibration, and linear stapling from 4-6 cm proximal to the pylorus to the angle of His. Standard perioperative care included VTE prophylaxis (enoxaparin 40 mg SC daily ×10 days, sequential compression devices) and methylene blue leak test. Follow-up at 1, 3, 6, and 12 months assessed weight loss, comorbidities, medication use, quality of life, and complications (Clavien-Dindo graded). Receives: Procedure: Laparoscopic Sleeve Gastrectomy (LSG); Behavioral: Structured Dietary Counseling |
| Conservative Management | Active comparator | Patients aged ≥65 years with BMI ≥40 kg/m² and ≥1 weight-related comorbidity received structured dietary counseling (500-800 kcal deficit by certified nutritionists) plus guideline-directed pharmacotherapy for comorbidities (T2D, HTN, OSA, osteoarthritis) in specialized clinics. No anti-obesity medications (e.g., GLP-1 agonists) were used due to patient refusal related to high cost and lack of insurance coverage. Follow-up at 1, 3, 6, and 12 months assessed weight, comorbidities, medication use, quality of life, and safety. Receives: Behavioral: Structured Dietary Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight-related comorbidity status at 12 months
Proportion of patients with change in comorbidity status at 12 months, including percentage requiring medication for each comorbidity (type 2 diabetes mellitus, hypertension, obstructive sleep apnea, osteoarthritis), medication dose change or discontinuation, and complete resolution of each condition.
Measured: Baseline to 12 months
Secondary outcomes (6)
Change in body mass index
Change in BMI (kg/m²) = 12-month BMI - baseline BMI
Measured: Baseline to 12 months
Change in HbA1c
Change in HbA1c (%) in patients with type 2 diabetes mellitus
Measured: Baseline to 12 months
Change in systolic blood pressure
Change in systolic blood pressure (mmHg) in patients with hypertension
Measured: Baseline to 12 months
Change in apnea-hypopnea index
Change in AHI (events/hour) by polysomnography in patients with obstructive sleep apnea
Measured: Baseline to 12 months
Change in knee joint space width
Change in minimum knee joint space width (mm) on standing AP radiographs in patients with osteoarthritis
Measured: Baseline to 12 months
Incidence of postoperative complications
Incidence and Clavien-Dindo grade of complications in LSG arm
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Jan 2023
- Primary completion1 Mar 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparascopic Sleeve GastrectomyStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups: Group A (n=30) underwent laparoscopic sleeve gastrectomy (LSG); Group B (n=30) received conservative management (dietary counseling + guideline-directed pharmacotherapy for comorbidities, no anti-obesity medications). Allocation by patient preference, prospective 12-month follow-up.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reda F. Ali, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437716
- Sponsor's protocol ID
- KFSIRB200-838
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are available upon reasonable request from the corresponding author (khaled.elsayed1495@alexmed.edu.eg), as stated in the manuscript.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Of Laparoscopic Sleeve Gastrectomy On Obesity-Related Comorbidities In Patients Over 65 Years: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT07437716
- Acronym / sponsor ID
- KFSIRB200-838
- Conditions
- Laparascopic Sleeve Gastrectomy, Obesity & Overweight, Obesity Type 2 Diabetes Mellitus, Obstructive Sleep Apnea (OSA), Hypertension (HTN), Osteo Arthritis of the Knee
- Keywords
- Obesity, Sleeve Gastrectomy, Type 2 Diabetes, Hypertension, Comorbidities, Bariatric Surgery, Obstructive Sleep Apnea, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 27 Feb 2026 (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.
This study compares laparoscopic sleeve gastrectomy (a type of weight-loss surgery) with non-surgical care in adults aged 65 or older who have severe obesity and related health problems like type 2 diabetes, high blood pressure, knee joint issues from osteoarthritis, or sleep apnea. Over 12 months, 60 patients chose either surgery or diet counseling with medications for their conditions (30 in each group). The main goals are to measure improvements in these health issues, weight loss, and safety.
Why This Study Matters Severe obesity in older adults raises risks for serious health conditions that diet and medications often fail to fix long-term. Surgery like sleeve gastrectomy removes part of the stomach to limit food intake and improve hormones that control hunger and blood sugar, but its benefits need direct proof against usual care in seniors.
What Happens in the Study Patients picked their treatment: surgery group got the procedure plus routine care; non-surgery group got nutrition advice and standard drugs. Doctors tracked weight, blood tests, blood pressure, sleep studies, knee X-rays, drug needs, and side effects at 1, 3, 6, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallel groups: Group A (n=30) underwent laparoscopic sleeve gastrectomy (LSG); Group B (n=30) received conservative management (dietary counseling + guideline-directed pharmacotherapy for comorbidities, no anti-obesity medications). Allocation by patient preference, prospective 12-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Sleeve Gastrectomy (LSG) | Experimental | Procedure: Laparoscopic Sleeve Gastrectomy (LSG), Behavioral: Structured Dietary CounselingPatients aged ≥65 years with BMI ≥40 kg/m² and ≥1 weight-related comorbidity underwent laparoscopic sleeve gastrectomy (LSG) under general anesthesia using the baseball diamond trocar technique, 34-Fr bougie calibration, and linear stapling from 4-6 cm proximal to the pylorus to the angle of His. Standard perioperative care included VTE prophylaxis (enoxaparin 40 mg SC daily ×10 days, sequential compression devices) and methylene blue leak test. Follow-up at 1, 3, 6, and 12 months assessed weight loss, comorbidities, medication use, quality of life, and complications (Clavien-Dindo graded). |
| Conservative Management | Active comparator | Behavioral: Structured Dietary CounselingPatients aged ≥65 years with BMI ≥40 kg/m² and ≥1 weight-related comorbidity received structured dietary counseling (500-800 kcal deficit by certified nutritionists) plus guideline-directed pharmacotherapy for comorbidities (T2D, HTN, OSA, osteoarthritis) in specialized clinics. No anti-obesity medications (e.g., GLP-1 agonists) were used due to patient refusal related to high cost and lack of insurance coverage. Follow-up at 1, 3, 6, and 12 months assessed weight, comorbidities, medication use, quality of life, and safety. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≥65 years
- Body Mass Index (BMI) ≥40 kg/m²
- Presence of at least one weight-related comorbidity: type 2 diabetes mellitus (T2D), hypertension (HTN), obstructive sleep apnea (OSA), or osteoarthritis (OA)
- Ability to provide informed consent and complete 12-month follow-up protocol
Key exclusion criteria (5 listed)
- Severe cardiopulmonary disease preventing surgery or follow-up
- Active malignancy
- Uncontrolled psychiatric illness
- Inability to comply with follow-up visits
- Previous abdominal 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 |
|---|---|---|
| Laparoscopic Sleeve Gastrectomy (LSG)Laparoscopic sleeve gastrectomy performed under general anesthesia using 5 trocars (baseball diamond technique), liver retraction (Nathanson), Ligasure dissection of greater curvature/short gastrics, 34-French bougie calibration along lesser curvature, sequential linear stapling (60-mm, 4-5 firings) from 4-6 cm proximal to pylorus to angle of His, staple line reinforcement optional, resected stomach removed via port, methylene blue leak test, and routine VTE prophylaxis (enoxaparin 40 mg SC daily ×10 days + sequential compression devices). | Procedure or surgery | Laparoscopic Sleeve Gastrectomy (LSG) |
| Structured Dietary CounselingStructured dietary counseling providing a 500-800 kcal daily deficit, delivered by certified nutritionists, combined with guideline-directed pharmacotherapy for weight-related comorbidities (type 2 diabetes, hypertension, osteoarthritis, obstructive sleep apnea) in specialized clinics. No anti-obesity pharmacotherapy (e.g., GLP-1 receptor agonists) due to high cost and lack of insurance coverage, per patient preference | Behavioural | Conservative Management, Laparoscopic Sleeve Gastrectomy (LSG) |
Primary outcome
Change in weight-related comorbidity status at 12 months
Time frame: Baseline to 12 months
Proportion of patients with change in comorbidity status at 12 months, including percentage requiring medication for each comorbidity (type 2 diabetes mellitus, hypertension, obstructive sleep apnea, osteoarthritis), medication dose change or discontinuation, and complete resolution of each condition.
6 secondary outcomes
Change in body mass index
Time frame: Baseline to 12 months
Change in HbA1c
Time frame: Baseline to 12 months
Change in systolic blood pressure
Time frame: Baseline to 12 months
Change in apnea-hypopnea index
Time frame: Baseline to 12 months
Change in knee joint space width
Time frame: Baseline to 12 months
Incidence of postoperative complications
Time frame: Baseline to 12 months
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 27 Feb 2026.
- Individual participant dataSharing planned: No. Data are available upon reasonable request from the corresponding author (khaled.elsayed1495@alexmed.edu.eg), as stated in the manuscript.
Related trials for Laparascopic Sleeve Gastrectomy
RecruitingEarly Phase 1
Ketamine for Shoulder Pain Following Laparoscopic Gastric Sleeve Surgery
Pain Management, Laparascopic Sleeve Gastrectomy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Sleeve Gastrectomy (LSG) and Structured Dietary Counseling in people with Laparascopic Sleeve Gastrectomy and Obesity & Overweight, run by Kafrelsheikh University at 1 site in Egypt.
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 4 inclusion and 5 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 27 Feb 2026. 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 Egypt. 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?
Change in weight-related comorbidity status at 12 months (time frame: Baseline to 12 months). 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 27 Feb 2026.