Impact Of Laparoscopic Sleeve Gastrectomy On Obesity-Related Comorbidities In Patients Over 65 Years

NCT07437716 | Completed

• 1 other identifier: KFSIRB200-838
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 12 months

Secondary Outcomes (6)

• Change in body mass index

  Baseline to 12 months

• Change in HbA1c

  Baseline to 12 months

• Change in systolic blood pressure

  Baseline to 12 months

• Change in apnea-hypopnea index

  Baseline to 12 months

• Change in knee joint space width

  Baseline to 12 months

Study Arms (2)

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).

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.

Behavioral: Structured Dietary Counseling

Interventions

Structured Dietary Counseling BEHAVIORAL

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

Conservative Management; Laparoscopic Sleeve Gastrectomy (LSG)

Laparoscopic Sleeve Gastrectomy (LSG) PROCEDURE

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).

Laparoscopic Sleeve Gastrectomy (LSG)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe cardiopulmonary disease preventing surgery or follow-up
• Active malignancy
• Uncontrolled psychiatric illness
• Inability to comply with follow-up visits
• Previous abdominal surgery

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Egypt

Location

MeSH Terms

Conditions

Obesity; Overweight; Sleep Apnea, Obstructive; Hypertension; Diabetes Mellitus, Type 2; Osteoarthritis

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Model Details: 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.

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 27, 2026
• Study Start: January 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)