Obesity & Overweight, Sleeve Gastrectomy
Conditions
Keywords
long-term follow-up, sleeve gastrectomy, obesity, metabolic outcomes, nutritional status, anthropometric measurements
Brief summary
Obesity is a major global public health concern, and bariatric surgery is recognized as the most effective treatment for achieving sustained weight loss and improving obesity-related comorbidities. Sleeve gastrectomy (SG) is one of the most commonly performed bariatric procedures; however, long-term outcomes vary considerably among individuals. While some patients maintain satisfactory weight loss, others experience suboptimal weight loss or weight regain several years after surgery. Evidence suggests that long-term weight trajectories after SG may be influenced by metabolic changes, dietary habits, and lifestyle factors, highlighting the need for extended follow-up studies. This observational cohort study aims to evaluate the long-term outcomes of individuals who underwent sleeve gastrectomy approximately 8 years ago. Anthropometric measurements, biochemical parameters, and nutritional status will be reassessed at an 8-year follow-up visit and compared with data obtained during the preoperative period and at postoperative 6 months. By examining within-subject changes over time, this study seeks to provide insight into the long-term sustainability of weight loss after sleeve gastrectomy and to identify metabolic and nutritional factors associated with long-term outcomes.
Interventions
None listed
Sponsors
Medipol University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-65 years * Patients who underwent sleeve gastrectomy approximately 8 years prior to study enrollment * Patients with available postoperative follow-up data at 6 months, including anthropometric measurements, biochemical parameters, and nutritional status assessments * Patients willing to participate in long-term follow-up and attend in-person evaluations
Exclusion criteria
* Pregnancy or lactation * Presence of acute illness or active infection at the time of evaluation * Presence of acute illness, infection, or comorbid conditions that may limit study safety or validity, including malignancy, type 1 diabetes mellitus, renal or hepatic failure, recent stroke or myocardial infarction, nephrolithiasis, drug or alcohol abuse, eating disorders, severe depression or other major psychiatric disorders, inflammatory bowel disease, cardiac arrhythmias or heart failure, respiratory failure, or chronic systemic corticosteroid therapy. * Professional athletes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Total Weight Loss (TWL%) | Postoperative 6 months and postoperative 8 years | Calculated as \[(preoperative weight - postoperative weight) / preoperative weight\] × 100. |
| Percent Excess Weight Loss (EWL%) | Postoperative 6 months and postoperative 8 years | Calculated as \[(preoperative weight - postoperative weight) / (preoperative weight - ideal body weight)\] × 100, where ideal body weight corresponds to a BMI of 25 kg/m². |
| Change in Body Fat Percentage | Preoperative baseline, postoperative 6 months, and postoperative 8 years | Changes in body fat percentage measured using multi-frequency bioelectrical impedance analysis (BIA). |
| Change in Skeletal Muscle Mass | Preoperative baseline, postoperative 6 months, and postoperative 8 years | Changes in skeletal muscle mass measured using multi-frequency bioelectrical impedance analysis (BIA). |
| Change in Fat Mass | Preoperative, postoperative 6 months, and postoperative 8 years | Changes in fat mass measured using multi-frequency bioelectrical impedance analysis (BIA). |
| Change in Body Weight | Preoperative, postoperative 6 months, and postoperative 8 years | Body weight measured using a calibrated digital scale with participants wearing light clothing and no shoes. |
| Change in Body Mass Index (BMI) | Preoperative, postoperative 6 months, and postoperative 8 years | BMI calculated as weight in kilograms divided by height in meters squared (kg/m²), measured using a wall-mounted stadiometer. |
| Change in Waist Circumference | Preoperative, postoperative 6 months, and postoperative 8 years | Waist circumference measured in centimeters at the midpoint between the subcostal margin and the iliac crest with participants standing upright. |
| Change in Hip Circumference | Preoperative, postoperative 6 months, and postoperative 8 years | Hip circumference measured in centimeters at the level of maximum gluteal protrusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fat-Free Mass | Preoperative baseline, postoperative 6 months, and postoperative 8 years | Changes in fat-free mass measured using multi-frequency bioelectrical impedance analysis (BIA). |
| Change in Total Protein | Preoperative baseline, postoperative 6 months, and postoperative 8 years | Changes in total serum protein levels measured from venous blood samples. |
| Change in Hemoglobin | Preoperative baseline, postoperative 6 months, and postoperative 8 years | Changes in hemoglobin levels measured from venous blood samples. |
| Change in Hematocrit | Preoperative baseline, postoperative 6 months, and postoperative 8 years | Changes in hematocrit levels measured from venous blood samples. |
| Change in Serum Ferritin | Preoperative baseline, postoperative 6 months, and postoperative 8 years | Changes in serum ferritin levels measured from venous blood samples. |
| Change in Glycated Hemoglobin (HbA1c) | Preoperative, postoperative 6 months, and postoperative 8 years | HbA1c levels measured to assess long-term glycemic control. |
| Change in Serum Iron | Preoperative baseline, postoperative 6 months, and postoperative 8 years | Changes in serum iron levels measured from venous blood samples. |
| Change in Fasting Plasma Glucose | Preoperative, postoperative 6 months, and postoperative 8 years | Fasting plasma glucose measured after at least 8 hours of fasting using venous blood samples. |
| Change in Fasting Insulin Levels | Preoperative, postoperative 6 months, and postoperative 8 years | Fasting insulin levels measured from venous blood samples obtained after at least 8 hours of fasting. |
| Change in Lipid Profile Parameters | Preoperative, postoperative 6 months, and postoperative 8 years | Serum lipid parameters including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides measured after an overnight fast. |
| Change in Liver Enzyme Levels | Preoperative, postoperative 6 months, and postoperative 8 years | Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels measured from fasting blood samples. |
| Change in Renal and Metabolic Biomarkers | Preoperative, postoperative 6 months, and postoperative 8 years | Serum urea and uric acid levels measured to assess renal and metabolic function. |
| Change in Serum Albumin | Preoperative, postoperative 6 months, and postoperative 8 years | Changes in serum albumin levels measured from venous blood samples. |
| Change in Micronutrient Levels | Preoperative, postoperative 6 months, and postoperative 8 years | Serum levels of vitamin B12, folic acid, magnesium, total calcium, sodium, and potassium measured to assess micronutrient status. |
| Change in Physical Activity Level | Preoperative, postoperative 6 months, and postoperative 8 years | Physical activity levels assessed using the International Physical Activity Questionnaire (IPAQ). |
Countries
Turkey (Türkiye)
Contacts
STUDY_DIRECTORSeher Şen
Mudanya University
Outcome results
None listed