Status:
COMPLETED
Interventions for Weight Regain After Bariatric Surgery
Lead Sponsor:
Medipol University
Conditions:
Obese Patients With Bariatric Surgery
Obese Patients (BMI ≥ 30 kg/m²)
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
Study Objective: The aim of this study is to evaluate the effects of revisional bariatric surgery (RBS), very low-calorie ketogenic diet (VLCKD), and intermittent fasting (IF) on nutritional habits a...
Detailed Description
Study Hypotheses: 1. In patients with IWL or WR after bariatric surgery, a diet following the bariatric care guidelines (BCGs) after revisional bariatric surgery (RBS) improves nutritional habits, an...
Eligibility Criteria
Inclusion
- Patients aged between 18 and 45 years who have undergone bariatric surgery (BS).
- Experiencing inadequate weight loss (IWL) within 18 months after surgery or weight regain (WR) following successful weight loss.
- Definitions used in the study:
- IWL is defined as \<50% excess weight loss (EWL) 18 months postoperatively. WR is defined as \>25% regain of the lost weight (from the lowest achieved weight).
- \-
Exclusion
- Pregnant or lactating women.
- Patients with acute illnesses, infections, or comorbidities that may affect treatment efficacy or safety (e.g., cancer, type 1 diabetes, renal or hepatic failure, recent stroke or myocardial infarction, nephrolithiasis, substance or alcohol abuse, eating disorders, severe depression or other psychiatric disorders, inflammatory bowel disease, neoplasms, arrhythmic heart diseases, heart failure, respiratory failure).
- Patients currently receiving corticosteroid therapy.
- Professional athletes.
Key Trial Info
Start Date :
May 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2025
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT06963437
Start Date
May 12 2025
End Date
July 10 2025
Last Update
August 1 2025
Active Locations (2)
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1
Özel Nev FSM Hastanesi
Bursa, Bursa, Turkey (Türkiye), 16160
2
Özel Nev FSM Hastanesi
Nilufer, Bursa, Turkey (Türkiye), 16160