An interventional study of Laparoscopic Sleeve Gastrectomy (LSG) and Structured Dietary Counseling in Laparascopic Sleeve Gastrectomy, Obesity & Overweight and Obesity Type 2 Diabetes Mellitus, sponsored by Kafrelsheikh University. Completed at 1 site in Egypt. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Kafrelsheikh University · Not applicable, Interventional, and Treatment
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 60 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
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Exclusion Criteria:
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).
Procedure: Laparoscopic Sleeve Gastrectomy (LSG) · Behavioral: Structured Dietary Counseling
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.
Behavioral: Structured Dietary Counseling
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 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
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.
Time frame: Baseline to 12 months
Change in body mass index
Change in BMI (kg/m²) = 12-month BMI - baseline BMI
Time frame: Baseline to 12 months
Change in HbA1c
Change in HbA1c (%) in patients with type 2 diabetes mellitus
Time frame: Baseline to 12 months
Change in systolic blood pressure
Change in systolic blood pressure (mmHg) in patients with hypertension
Time frame: Baseline to 12 months
Change in apnea-hypopnea index
Change in AHI (events/hour) by polysomnography in patients with obstructive sleep apnea
Time frame: 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
Time frame: Baseline to 12 months
Incidence of postoperative complications
Incidence and Clavien-Dindo grade of complications in LSG arm
Time frame: Baseline to 12 months
Plan to share: No — Data are available upon reasonable request from the corresponding author (khaled.elsayed1495@alexmed.edu.eg), as stated in the manuscript.
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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Kafrelsheikh University