Comparison of Revisional Surgery, Ketogenic Diet, and Intermittent Fasting in Bariatric Surgery Patients With Weight Regain: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 3
- 主要终点
- Change in Body Weight (kg)
研究概览
简要总结
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.
详细描述
Study Hypotheses:
- 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, anthropometric, and biochemical parameters.
- In patients with IWL or WR after bariatric surgery, VLCKD improves nutritional habits, anthropometric, and biochemical parameters.
- In patients with IWL or WR after bariatric surgery, IF regimen improves nutritional habits, anthropometric, and biochemical parameters.
- In patients with IWL or WR after bariatric surgery, the diet program recommended by the ASMBS as part of standard post-bariatric care improves nutritional habits, anthropometric measurements, and biochemical parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Change in Body Weight (kg)
时间窗: Baseline and Week 6
Body weight will be measured at baseline and at Week 6 using a calibrated digital scale while participants are wearing light clothing and no shoes. Statistical analyses will be performed using SPSS v22.0. Normality will be tested using Shapiro-Wilk. ANOVA or Kruskal-Wallis will be used as appropriate; p\<0.05 considered significant.
Change in Body Mass Index (kg/m²)
时间窗: Baseline and Week 6
BMI will be calculated as weight (kg) divided by the square of height (m²), using body weight and height measurements obtained with a digital scale and a wall-mounted stadiometer. Statistical analyses will be performed using SPSS v22.0. Normality will be tested using Shapiro-Wilk. ANOVA or Kruskal-Wallis will be used as appropriate; p\<0.05 considered significant.
Change in Waist Circumference (cm)
时间窗: Baseline and Week 6
Waist circumference will be measured using a non-elastic measuring tape while participants are standing upright. The measurement will be taken 5 cm below the umbilicus. Statistical analyses will be performed using SPSS v22.0. Normality will be tested using Shapiro-Wilk. ANOVA or Kruskal-Wallis will be used as appropriate; p\<0.05 considered significant.
Change in Body Composition (Fat Mass %, Muscle Mass %,) assessed by BIA
时间窗: Baseline and Week 6
Body composition parameters, including fat mass (%), fat-free mass (%), muscle mass (%), and ECW/TBW ratio, will be assessed using multi-frequency segmental bioelectrical impedance analysis (BIA) (Tanita MC-780 MA, Korea). Assessments will follow ESPEN guidelines. Statistical analyses will be performed using SPSS v22.0. Normality will be tested using Shapiro-Wilk. ANOVA or Kruskal-Wallis will be used as appropriate; p\<0.05 considered significant.
Percentage Weight Loss (%WL)
时间窗: Baseline and Week 6
%WL will be calculated using the formula: \[(Preoperative weight - Postoperative weight) / Preoperative weight\] × 100
Percentage Excess Weight Loss (%EWL)
时间窗: Baseline and Week 6
%EWL will be calculated using the formula: \[(Preoperative weight - Postoperative weight) / (Preoperative weight - Ideal weight)\] ×100 \*Ideal weight is defined as the weight corresponding to a BMI of 25 kg/m².\*
次要结局
- Change in Fasting Blood Glucose (mg/dL)(Baseline and Week 6)
- Change in Fasting Insulin (µIU/mL)(Baseline and Week 6)
- Change in Lipid Profile (HDL, LDL, Total Cholesterol, Triglycerides) (mg/dL)(Baseline and Week 6)
- Change in Renal Function Markers (BUN, Creatinine, Uric Acid, Urea) (mg/dL)(Baseline and Week 6)
- Change in Liver Function Tests (ALT, AST, Albumin, Total Protein) (U/L, g/dL)(Baseline and Week 6)
- Change in Vitamin and Mineral Status (Vitamin B12, Folic Acid, Magnesium, Calcium, Sodium, Potassium) (ng/L, mg/dL, mmol/L, etc.)(Baseline and Week 6)
- Change in Hematological Parameters (Hemoglobin, Hematocrit, Ferritin, Serum Iron, TIBC) (g/dL, µg/L, etc.)(Baseline and Week 6)
- Change in Daily Energy and Macronutrient Intake(Baseline and Week 6)
- Change in Micronutrient Intake(Baseline and Week 6)
研究者
Seher Dallı Şen
Seher Dallı Şen, PhD Candidate in Nutrition and Dietetic
Medipol University