- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07345429
One-Year Outcomes After Conversion Bariatric Surgery
ONE-YEAR OUTCOMES OF ANTHROPOMETRIC, BIOCHEMICAL, AND NUTRITIONAL PARAMETERS AFTER CONVERSION BARIATRIC SURGERY
Obesity is a growing global public health problem, and bariatric surgery is currently the most effective treatment for achieving sustained weight loss and improving obesity-related comorbidities. However, a subset of patients experience inadequate weight loss or weight regain following primary bariatric surgery, which may lead to the recurrence of metabolic complications and reduced quality of life. In such cases, conversion bariatric surgery, defined as the surgical conversion from one bariatric procedure to another, is considered an important therapeutic option. Despite the increasing number of conversion procedures, comprehensive longitudinal data evaluating anthropometric, biochemical, and nutritional outcomes after conversion bariatric surgery remain limited.
This study aims to prospectively evaluate individuals undergoing conversion bariatric surgery due to weight regain following primary bariatric surgery. Anthropometric measurements, biochemical parameters, and nutritional status will be assessed preoperatively and at 1 year after surgery. By evaluating weight loss outcomes together with metabolic and nutritional changes, this study seeks to provide clinically relevant evidence to guide postoperative follow-up strategies, optimize nutritional management, and support multidisciplinary care in patients undergoing conversion bariatric surgery.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
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Bursa
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Osmangazi, Bursa, Turkey (Türkiye), 16160
- 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 18-45 years
- Previously underwent bariatric surgery
- Subsequently underwent conversion bariatric surgery due to suboptimal clinical response
Suboptimal clinical response defined as either:
- Suboptimal Clinical Response (SCR): maximum total weight loss (TWL%) of <20% within 18 months after metabolic and bariatric surgery
- Recurrent Weight Gain (RWG): regaining >30% of initial postoperative weight loss after achieving initial weight reduction
Exclusion Criteria:
- Pregnancy or lactation
- Presence of acute illness or infection
- Comorbid conditions that could limit treatment efficacy or compromise safety
- Participation in professional athletic activity
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Conversion Bariatric Surgery
This cohort includes patients who previously underwent conversion bariatric surgery as part of routine clinical care and were followed observationally.
Anthropometric measurements, biochemical parameters, and nutritional status were assessed at the preoperative period and postoperative month 12 (1 year).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Body Composition Parameters
Time Frame: Preoperative baseline and postoperative 1 year
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Body composition parameters including fat mass, fat percentage, fat-free mass, fat-free mass percentage, skeletal muscle mass, muscle percentage, and extracellular water to total body water ratio assessed using multi-frequency bioelectrical impedance analysis (BIA).
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Preoperative baseline and postoperative 1 year
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Change in Body Weight
Time Frame: Preoperative baseline and postoperative 1 year
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Change in body weight (kg) measured using a digital scale with participants wearing light clothing and no shoes.
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Preoperative baseline and postoperative 1 year
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Change in Body Mass Index (BMI)
Time Frame: Preoperative baseline and postoperative 1 year
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Change in body mass index (kg/m²) calculated from measured body weight and height.
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Preoperative baseline and postoperative 1 year
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Percentage of Total Weight Loss
Time Frame: postoperative 1 year
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Percentage of total weight loss calculated as [(preoperative weight - postoperative weight) / preoperative weight] × 100.
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postoperative 1 year
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Percentage of Excess Weight Loss
Time Frame: postoperative 1 year
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Percentage of excess weight loss calculated as [(preoperative weight - postoperative weight) / (preoperative weight - ideal body weight)] × 100, with ideal body weight defined as a BMI of 25 kg/m².
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postoperative 1 year
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Change in Waist Circumference
Time Frame: Preoperative baseline and postoperative 1 year
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Waist circumference (cm) measured in the standing position using a non-elastic measuring tape at the midpoint between the lowest rib and the iliac crest.
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Preoperative baseline and postoperative 1 year
|
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Change in Hip Circumference
Time Frame: Preoperative baseline and postoperative 1 year
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Hip circumference (cm) measured in the standing position at the point of maximum protrusion of the gluteal muscles using a non-elastic measuring tape.
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Preoperative baseline and postoperative 1 year
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Change in Body Fat Percentage (%)
Time Frame: Preoperative baseline and postoperative 1 year
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Body fat percentage measured using multi-frequency bioelectrical impedance analysis (BIA).
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Preoperative baseline and postoperative 1 year
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Change in Fat-Free Mass (kg)
Time Frame: Preoperative baseline and postoperative 1 year
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Fat-free mass measured using multi-frequency bioelectrical impedance analysis (BIA).
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Preoperative baseline and postoperative 1 year
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Change in Skeletal Muscle Mass (kg)
Time Frame: Preoperative baseline and postoperative 1 year
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Skeletal muscle mass measured using multi-frequency bioelectrical impedance analysis (BIA).
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Preoperative baseline and postoperative 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Fasting Plasma Glucose
Time Frame: Preoperative baseline and postoperative 1 year
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Changes in fasting plasma glucose levels measured from venous blood samples.
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Preoperative baseline and postoperative 1 year
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Change in Alanine Aminotransferase (ALT)
Time Frame: Preoperative baseline and postoperative 1 year
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Changes in alanine aminotransferase (ALT) levels measured from venous blood samples.
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Preoperative baseline and postoperative 1 year
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Change in Hematological Parameters
Time Frame: Preoperative baseline and postoperative 1 year
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Changes in hemoglobin and hematocrit levels measured from venous blood samples.
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Preoperative baseline and postoperative 1 year
|
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Change in Iron Status Parameters
Time Frame: Preoperative baseline and postoperative 1 year
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Changes in serum ferritin, serum iron, and total iron-binding capacity levels measured from venous blood samples.
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Preoperative baseline and postoperative 1 year
|
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Change in Micronutrient and Electrolyte Levels
Time Frame: Preoperative baseline and postoperative 1 year
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Changes in serum vitamin B12, folic acid, magnesium, total calcium, sodium, and potassium levels measured from venous blood samples.
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Preoperative baseline and postoperative 1 year
|
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Change in Fasting Insulin
Time Frame: Preoperative baseline and postoperative 1 year
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Changes in fasting insulin levels measured from venous blood samples.
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Preoperative baseline and postoperative 1 year
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Change in Glycated Hemoglobin (HbA1c)
Time Frame: Preoperative baseline and postoperative 1 year
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Changes in glycated hemoglobin (HbA1c) levels measured from venous blood samples.
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Preoperative baseline and postoperative 1 year
|
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Change in Total Cholesterol
Time Frame: Preoperative baseline and postoperative 1 year
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Changes in total cholesterol levels measured from venous blood samples.
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Preoperative baseline and postoperative 1 year
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Change in LDL Cholesterol
Time Frame: Preoperative baseline and postoperative 1 year
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Changes in low-density lipoprotein (LDL) cholesterol levels measured from venous blood samples.
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Preoperative baseline and postoperative 1 year
|
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Change in HDL Cholesterol
Time Frame: Preoperative baseline and postoperative 1 year
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Changes in high-density lipoprotein (HDL) cholesterol levels measured from venous blood samples.
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Preoperative baseline and postoperative 1 year
|
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Change in Triglyceride Levels
Time Frame: Preoperative baseline and postoperative 1 year
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Changes in triglyceride levels measured from venous blood samples
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Preoperative baseline and postoperative 1 year
|
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Change in Aspartate Aminotransferase (AST)
Time Frame: Preoperative baseline and postoperative 1 year
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Changes in aspartate aminotransferase (AST) levels measured from venous blood samples.
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Preoperative baseline and postoperative 1 year
|
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Change in Urea Levels
Time Frame: Preoperative baseline and postoperative 1 year
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Changes in serum urea levels measured from venous blood samples.
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Preoperative baseline and postoperative 1 year
|
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Change in Uric Acid Levels
Time Frame: Preoperative baseline and postoperative 1 year
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Changes in serum uric acid levels measured from venous blood samples.
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Preoperative baseline and postoperative 1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Seher Şen, Assistant Professor, 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-01
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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