Hypertension (HTN), Laparascopic Sleeve Gastrectomy, Obesity & Overweight, Obesity Type 2 Diabetes Mellitus, Obstructive Sleep Apnea (OSA), Osteo Arthritis of the Knee
Conditions
Keywords
Obesity, Sleeve Gastrectomy, Type 2 Diabetes, Hypertension, Comorbidities, Bariatric Surgery, Obstructive Sleep Apnea, Osteoarthritis
Brief 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. 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.
Interventions
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).
BEHAVIORALStructured Dietary Counseling
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
Sponsors
Kafrelsheikh University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Severe cardiopulmonary disease preventing surgery or follow-up * Active malignancy * Uncontrolled psychiatric illness * Inability to comply with follow-up visits * Previous abdominal surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight-related comorbidity status at 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body mass index | Baseline to 12 months | Change in BMI (kg/m²) = 12-month BMI - baseline BMI |
| Change in HbA1c | Baseline to 12 months | Change in HbA1c (%) in patients with type 2 diabetes mellitus |
| Change in systolic blood pressure | Baseline to 12 months | Change in systolic blood pressure (mmHg) in patients with hypertension |
| Change in apnea-hypopnea index | Baseline to 12 months | Change in AHI (events/hour) by polysomnography in patients with obstructive sleep apnea |
| Change in knee joint space width | Baseline to 12 months | Change in minimum knee joint space width (mm) on standing AP radiographs in patients with osteoarthritis |
| Incidence of postoperative complications | Baseline to 12 months | Incidence and Clavien-Dindo grade of complications in LSG arm |
Countries
Egypt
Outcome results
None listed