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NCT Number: NCT07437716

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

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.

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Key information

Conditions

Laparascopic Sleeve Gastrectomy Apnea Arthritis Body Weight Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Hypertension Hypertension (HTN) Joint Diseases Metabolic Diseases Musculoskeletal Diseases Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity & Overweight Obesity Type 2 Diabetes Mellitus Obstructive Sleep Apnea (OSA) Osteo Arthritis of the Knee Osteoarthritis Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Rheumatic Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University

Kafr ash Shaykh, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in body mass index

    Time frame: Baseline to 12 months

    Change in BMI (kg/m²) = 12-month BMI - baseline BMI

  2. Change in HbA1c

    Time frame: Baseline to 12 months

    Change in HbA1c (%) in patients with type 2 diabetes mellitus

  3. Change in systolic blood pressure

    Time frame: Baseline to 12 months

    Change in systolic blood pressure (mmHg) in patients with hypertension

  4. Change in apnea-hypopnea index

    Time frame: Baseline to 12 months

    Change in AHI (events/hour) by polysomnography in patients with obstructive sleep apnea

  5. Change in knee joint space width

    Time frame: Baseline to 12 months

    Change in minimum knee joint space width (mm) on standing AP radiographs in patients with osteoarthritis

  6. Incidence of postoperative complications

    Time frame: Baseline to 12 months

    Incidence and Clavien-Dindo grade of complications in LSG arm

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

Impact Of Laparoscopic Sleeve Gastrectomy On Obesity-Related Comorbidities In Patients Over 65 Years: A Prospective Comparative Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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