CompletedNot Applicable

Interventions for Weight Regain After Bariatric Surgery

Turkey (Türkiye)43 participantsStarted 2025-05-12

Plain-language 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 and clinical outcomes (anthropometric and biochemical measurements) in patients with insufficient weight loss (IWL) or weight regain (WR) after bariatric surgery, and to compare these findings with those of a control group.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Body Weight (kg)

Timeframe: Baseline and Week 6

Change in Body Mass Index (kg/m²)

Timeframe: Baseline and Week 6

Change in Waist Circumference (cm)

Timeframe: Baseline and Week 6

Change in Body Composition (Fat Mass %, Muscle Mass %,) assessed by BIA

Timeframe: Baseline and Week 6

Percentage Weight Loss (%WL)

Timeframe: Baseline and Week 6

Percentage Excess Weight Loss (%EWL)

Timeframe: Baseline and Week 6

Trial details

NCT IDNCT06963437

SponsorMedipol University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-10

View on ClinicalTrials.gov More Obese Patients With Bariatric Surgery trials

Plain-language summary

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Body Weight (kg)

Timeframe: Baseline and Week 6

Change in Body Mass Index (kg/m²)

Timeframe: Baseline and Week 6

Change in Waist Circumference (cm)

Timeframe: Baseline and Week 6

Change in Body Composition (Fat Mass %, Muscle Mass %,) assessed by BIA

Timeframe: Baseline and Week 6

Percentage Weight Loss (%WL)

Timeframe: Baseline and Week 6

Percentage Excess Weight Loss (%EWL)

Timeframe: Baseline and Week 6