8-Year Outcomes After Sleeve Gastrectomy

February 2, 2026 updated by: Seher Şen, Medipol University

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

Active, not recruiting

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population includes adults aged 18-65 years who underwent sleeve gastrectomy approximately eight years prior to enrollment and completed standard postoperative follow-up. Participants had available preoperative and 6-month postoperative anthropometric, biochemical, and nutritional data and were re-evaluated at 8 years after surgery to assess long-term outcomes.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fat Mass
Time Frame: Preoperative, postoperative 6 months, and postoperative 8 years
Changes in fat mass measured using multi-frequency bioelectrical impedance analysis (BIA).
Preoperative, postoperative 6 months, and postoperative 8 years
Change in Body Weight
Time Frame: Preoperative, postoperative 6 months, and postoperative 8 years
Body weight measured using a calibrated digital scale with participants wearing light clothing and no shoes.
Preoperative, postoperative 6 months, and postoperative 8 years
Change in Body Mass Index (BMI)
Time Frame: 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.
Preoperative, postoperative 6 months, and postoperative 8 years
Change in Waist Circumference
Time Frame: 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.
Preoperative, postoperative 6 months, and postoperative 8 years
Change in Hip Circumference
Time Frame: Preoperative, postoperative 6 months, and postoperative 8 years
Hip circumference measured in centimeters at the level of maximum gluteal protrusion.
Preoperative, postoperative 6 months, and postoperative 8 years
Percent Total Weight Loss (TWL%)
Time Frame: Postoperative 6 months and postoperative 8 years
Calculated as [(preoperative weight - postoperative weight) / preoperative weight] × 100.
Postoperative 6 months and postoperative 8 years
Percent Excess Weight Loss (EWL%)
Time Frame: 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.
Postoperative 6 months and postoperative 8 years
Change in Body Fat Percentage
Time Frame: Preoperative baseline, postoperative 6 months, and postoperative 8 years
Changes in body fat percentage measured using multi-frequency bioelectrical impedance analysis (BIA).
Preoperative baseline, postoperative 6 months, and postoperative 8 years
Change in Skeletal Muscle Mass
Time Frame: Preoperative baseline, postoperative 6 months, and postoperative 8 years
Changes in skeletal muscle mass measured using multi-frequency bioelectrical impedance analysis (BIA).
Preoperative baseline, postoperative 6 months, and postoperative 8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fasting Plasma Glucose
Time Frame: Preoperative, postoperative 6 months, and postoperative 8 years
Fasting plasma glucose measured after at least 8 hours of fasting using venous blood samples.
Preoperative, postoperative 6 months, and postoperative 8 years
Change in Fasting Insulin Levels
Time Frame: Preoperative, postoperative 6 months, and postoperative 8 years
Fasting insulin levels measured from venous blood samples obtained after at least 8 hours of fasting.
Preoperative, postoperative 6 months, and postoperative 8 years
Change in Glycated Hemoglobin (HbA1c)
Time Frame: Preoperative, postoperative 6 months, and postoperative 8 years
HbA1c levels measured to assess long-term glycemic control.
Preoperative, postoperative 6 months, and postoperative 8 years
Change in Lipid Profile Parameters
Time Frame: 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.
Preoperative, postoperative 6 months, and postoperative 8 years
Change in Liver Enzyme Levels
Time Frame: Preoperative, postoperative 6 months, and postoperative 8 years
Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels measured from fasting blood samples.
Preoperative, postoperative 6 months, and postoperative 8 years
Change in Renal and Metabolic Biomarkers
Time Frame: Preoperative, postoperative 6 months, and postoperative 8 years
Serum urea and uric acid levels measured to assess renal and metabolic function.
Preoperative, postoperative 6 months, and postoperative 8 years
Change in Serum Albumin
Time Frame: Preoperative, postoperative 6 months, and postoperative 8 years
Changes in serum albumin levels measured from venous blood samples.
Preoperative, postoperative 6 months, and postoperative 8 years
Change in Micronutrient Levels
Time Frame: 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.
Preoperative, postoperative 6 months, and postoperative 8 years
Change in Physical Activity Level
Time Frame: Preoperative, postoperative 6 months, and postoperative 8 years
Physical activity levels assessed using the International Physical Activity Questionnaire (IPAQ).
Preoperative, postoperative 6 months, and postoperative 8 years
Change in Fat-Free Mass
Time Frame: Preoperative baseline, postoperative 6 months, and postoperative 8 years
Changes in fat-free mass measured using multi-frequency bioelectrical impedance analysis (BIA).
Preoperative baseline, postoperative 6 months, and postoperative 8 years
Change in Total Protein
Time Frame: Preoperative baseline, postoperative 6 months, and postoperative 8 years
Changes in total serum protein levels measured from venous blood samples.
Preoperative baseline, postoperative 6 months, and postoperative 8 years
Change in Hemoglobin
Time Frame: Preoperative baseline, postoperative 6 months, and postoperative 8 years
Changes in hemoglobin levels measured from venous blood samples.
Preoperative baseline, postoperative 6 months, and postoperative 8 years
Change in Hematocrit
Time Frame: Preoperative baseline, postoperative 6 months, and postoperative 8 years
Changes in hematocrit levels measured from venous blood samples.
Preoperative baseline, postoperative 6 months, and postoperative 8 years
Change in Serum Ferritin
Time Frame: Preoperative baseline, postoperative 6 months, and postoperative 8 years
Changes in serum ferritin levels measured from venous blood samples.
Preoperative baseline, postoperative 6 months, and postoperative 8 years
Change in Serum Iron
Time Frame: Preoperative baseline, postoperative 6 months, and postoperative 8 years
Changes in serum iron levels measured from venous blood samples.
Preoperative baseline, postoperative 6 months, and postoperative 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Seher Şen, Mudanya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2025

Primary Completion (Actual)

January 10, 2026

Study Completion (Estimated)

March 10, 2026

Study Registration Dates

First Submitted

December 18, 2025

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 16, 2026

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to the need to protect patient privacy and confidentiality. T

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Sleeve Gastrectomy

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