- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07348822
8-Year Outcomes After Sleeve Gastrectomy
8-Year Outcomes After Sleeve Gastrectomy: Anthropometric, Biochemical, and Nutritional Evaluation
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 Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Mudanya
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Bursa, Mudanya, Turkey (Türkiye)
- Mudanya Univesity
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Sleeve Gastrectomy Long-Term Follow-up Cohort
This cohort includes adults who underwent sleeve gastrectomy between 2016 and 2017 and were re-evaluated approximately 8 years after surgery.
Participants are followed observationally, with anthropometric measurements, biochemical parameters, and nutritional status assessed preoperatively, at postoperative 6 months, and at long-term (8-year) follow-up.
No intervention is assigned as part of the study protocol; all surgical procedures were performed as part of routine clinical care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in Fat Mass
Time Frame: Preoperative, postoperative 6 months, and postoperative 8 years
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Changes in fat mass measured using multi-frequency bioelectrical impedance analysis (BIA).
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Preoperative, postoperative 6 months, and postoperative 8 years
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Change in Body Weight
Time Frame: Preoperative, postoperative 6 months, and postoperative 8 years
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Body weight measured using a calibrated digital scale with participants wearing light clothing and no shoes.
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Preoperative, postoperative 6 months, and postoperative 8 years
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Change in Body Mass Index (BMI)
Time Frame: Preoperative, postoperative 6 months, and postoperative 8 years
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BMI calculated as weight in kilograms divided by height in meters squared (kg/m²), measured using a wall-mounted stadiometer.
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Preoperative, postoperative 6 months, and postoperative 8 years
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Change in Waist Circumference
Time Frame: Preoperative, postoperative 6 months, and postoperative 8 years
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Waist circumference measured in centimeters at the midpoint between the subcostal margin and the iliac crest with participants standing upright.
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Preoperative, postoperative 6 months, and postoperative 8 years
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Change in Hip Circumference
Time Frame: Preoperative, postoperative 6 months, and postoperative 8 years
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Hip circumference measured in centimeters at the level of maximum gluteal protrusion.
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Preoperative, postoperative 6 months, and postoperative 8 years
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Percent Total Weight Loss (TWL%)
Time Frame: Postoperative 6 months and postoperative 8 years
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Calculated as [(preoperative weight - postoperative weight) / preoperative weight] × 100.
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Postoperative 6 months and postoperative 8 years
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Percent Excess Weight Loss (EWL%)
Time Frame: Postoperative 6 months and postoperative 8 years
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Calculated as [(preoperative weight - postoperative weight) / (preoperative weight - ideal body weight)] × 100, where ideal body weight corresponds to a BMI of 25 kg/m².
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Postoperative 6 months and postoperative 8 years
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Change in Body Fat Percentage
Time Frame: Preoperative baseline, postoperative 6 months, and postoperative 8 years
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Changes in body fat percentage measured using multi-frequency bioelectrical impedance analysis (BIA).
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Preoperative baseline, postoperative 6 months, and postoperative 8 years
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Change in Skeletal Muscle Mass
Time Frame: Preoperative baseline, postoperative 6 months, and postoperative 8 years
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Changes in skeletal muscle mass measured using multi-frequency bioelectrical impedance analysis (BIA).
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Preoperative baseline, postoperative 6 months, and postoperative 8 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Fasting Plasma Glucose
Time Frame: Preoperative, postoperative 6 months, and postoperative 8 years
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Fasting plasma glucose measured after at least 8 hours of fasting using venous blood samples.
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Preoperative, postoperative 6 months, and postoperative 8 years
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Change in Fasting Insulin Levels
Time Frame: Preoperative, postoperative 6 months, and postoperative 8 years
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Fasting insulin levels measured from venous blood samples obtained after at least 8 hours of fasting.
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Preoperative, postoperative 6 months, and postoperative 8 years
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Change in Glycated Hemoglobin (HbA1c)
Time Frame: Preoperative, postoperative 6 months, and postoperative 8 years
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HbA1c levels measured to assess long-term glycemic control.
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Preoperative, postoperative 6 months, and postoperative 8 years
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Change in Lipid Profile Parameters
Time Frame: Preoperative, postoperative 6 months, and postoperative 8 years
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Serum lipid parameters including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides measured after an overnight fast.
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Preoperative, postoperative 6 months, and postoperative 8 years
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Change in Liver Enzyme Levels
Time Frame: Preoperative, postoperative 6 months, and postoperative 8 years
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Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels measured from fasting blood samples.
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Preoperative, postoperative 6 months, and postoperative 8 years
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Change in Renal and Metabolic Biomarkers
Time Frame: Preoperative, postoperative 6 months, and postoperative 8 years
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Serum urea and uric acid levels measured to assess renal and metabolic function.
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Preoperative, postoperative 6 months, and postoperative 8 years
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Change in Serum Albumin
Time Frame: Preoperative, postoperative 6 months, and postoperative 8 years
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Changes in serum albumin levels measured from venous blood samples.
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Preoperative, postoperative 6 months, and postoperative 8 years
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Change in Micronutrient Levels
Time Frame: Preoperative, postoperative 6 months, and postoperative 8 years
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Serum levels of vitamin B12, folic acid, magnesium, total calcium, sodium, and potassium measured to assess micronutrient status.
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Preoperative, postoperative 6 months, and postoperative 8 years
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Change in Physical Activity Level
Time Frame: Preoperative, postoperative 6 months, and postoperative 8 years
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Physical activity levels assessed using the International Physical Activity Questionnaire (IPAQ).
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Preoperative, postoperative 6 months, and postoperative 8 years
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Change in Fat-Free Mass
Time Frame: Preoperative baseline, postoperative 6 months, and postoperative 8 years
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Changes in fat-free mass measured using multi-frequency bioelectrical impedance analysis (BIA).
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Preoperative baseline, postoperative 6 months, and postoperative 8 years
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Change in Total Protein
Time Frame: Preoperative baseline, postoperative 6 months, and postoperative 8 years
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Changes in total serum protein levels measured from venous blood samples.
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Preoperative baseline, postoperative 6 months, and postoperative 8 years
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Change in Hemoglobin
Time Frame: Preoperative baseline, postoperative 6 months, and postoperative 8 years
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Changes in hemoglobin levels measured from venous blood samples.
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Preoperative baseline, postoperative 6 months, and postoperative 8 years
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Change in Hematocrit
Time Frame: Preoperative baseline, postoperative 6 months, and postoperative 8 years
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Changes in hematocrit levels measured from venous blood samples.
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Preoperative baseline, postoperative 6 months, and postoperative 8 years
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Change in Serum Ferritin
Time Frame: Preoperative baseline, postoperative 6 months, and postoperative 8 years
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Changes in serum ferritin levels measured from venous blood samples.
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Preoperative baseline, postoperative 6 months, and postoperative 8 years
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Change in Serum Iron
Time Frame: Preoperative baseline, postoperative 6 months, and postoperative 8 years
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Changes in serum iron levels measured from venous blood samples.
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Preoperative baseline, postoperative 6 months, and postoperative 8 years
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Seher Şen, Mudanya University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MUDU-SBE-SS-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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