8-Year Outcomes After Sleeve Gastrectomy

N/AActive Not RecruitingNCT07348822

Medipol University20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Sleeve Gastrectomy Obesity & Overweight

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in Fat Mass

Changes in fat mass measured using multi-frequency bioelectrical impedance analysis (BIA).

Time frame: Preoperative, postoperative 6 months, and postoperative 8 years

Change in Body Weight

Body weight measured using a calibrated digital scale with participants wearing light clothing and no shoes.

Time frame: Preoperative, postoperative 6 months, and postoperative 8 years

Change in Body Mass Index (BMI)

BMI calculated as weight in kilograms divided by height in meters squared (kg/m²), measured using a wall-mounted stadiometer.

Time frame: Preoperative, postoperative 6 months, and postoperative 8 years

Change in Waist Circumference

Waist circumference measured in centimeters at the midpoint between the subcostal margin and the iliac crest with participants standing upright.

Time frame: Preoperative, postoperative 6 months, and postoperative 8 years

Change in Hip Circumference

Hip circumference measured in centimeters at the level of maximum gluteal protrusion.

Time frame: Preoperative, postoperative 6 months, and postoperative 8 years

Percent Total Weight Loss (TWL%)

Calculated as \[(preoperative weight - postoperative weight) / preoperative weight\] × 100.

Time frame: Postoperative 6 months and postoperative 8 years

Percent Excess Weight Loss (EWL%)

Calculated as \[(preoperative weight - postoperative weight) / (preoperative weight - ideal body weight)\] × 100, where ideal body weight corresponds to a BMI of 25 kg/m².

Time frame: Postoperative 6 months and postoperative 8 years

Change in Body Fat Percentage

Changes in body fat percentage measured using multi-frequency bioelectrical impedance analysis (BIA).

Time frame: Preoperative baseline, postoperative 6 months, and postoperative 8 years

Change in Skeletal Muscle Mass

Changes in skeletal muscle mass measured using multi-frequency bioelectrical impedance analysis (BIA).

Time frame: Preoperative baseline, postoperative 6 months, and postoperative 8 years

Secondary Outcomes

Change in Fasting Plasma Glucose

Fasting plasma glucose measured after at least 8 hours of fasting using venous blood samples.

Time frame: Preoperative, postoperative 6 months, and postoperative 8 years

Change in Fasting Insulin Levels

Fasting insulin levels measured from venous blood samples obtained after at least 8 hours of fasting.

Time frame: Preoperative, postoperative 6 months, and postoperative 8 years

Change in Glycated Hemoglobin (HbA1c)

HbA1c levels measured to assess long-term glycemic control.

Time frame: Preoperative, postoperative 6 months, and postoperative 8 years

Change in Lipid Profile Parameters

Serum lipid parameters including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides measured after an overnight fast.

Time frame: Preoperative, postoperative 6 months, and postoperative 8 years

Change in Liver Enzyme Levels

Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels measured from fasting blood samples.

Time frame: Preoperative, postoperative 6 months, and postoperative 8 years

Change in Renal and Metabolic Biomarkers

Serum urea and uric acid levels measured to assess renal and metabolic function.

Time frame: Preoperative, postoperative 6 months, and postoperative 8 years

Change in Serum Albumin

Changes in serum albumin levels measured from venous blood samples.

Time frame: Preoperative, postoperative 6 months, and postoperative 8 years

Change in Micronutrient Levels

Serum levels of vitamin B12, folic acid, magnesium, total calcium, sodium, and potassium measured to assess micronutrient status.

8-Year Outcomes After Sleeve Gastrectomy

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes