Nutritional Status After Sleeve Gastrectomy in Morbid Obesity: 6-Month Study

Completed

• Conditions: Bariatric Surgery Candidate; Gastrostomy; Obesity

• Registration Number: NCT06368232
• Lead Sponsor: Ankara Yildirim Beyazıt University

Brief Summary

This study aims to evaluate the nutritional status of morbidly obese patients following gastric bypass surgery. Data from 76 patients aged 19-64, who will be monitored by a dietitian for at least six months, will be analyzed. Preoperative and postoperative biochemical parameters along with anthropometric measurements will assess.

Detailed Description

Objective: This retrospective study aims to evaluate the nutritional status of morbidly obese patients in the first six months following sleeve gastrectomy.

Methods: The study is planned as a retrospective analysis. The data of 76 patients aged 19-64 years who underwent bariatric surgery and were monitored by a dietitian for at least six months will be included in the study. Preoperative and postoperative biochemical parameters and anthropometric measurements of the patients will be collected and analyzed.

Detailed Description: The study will assess the changes in nutritional status, including body weight, BMI, fasting blood glucose, HbA1c, Homa-IR, iron levels, vitamin D levels, and lipid profile (triglycerides, LDL, HDL) among morbidly obese patients in the first six months following sleeve gastrectomy. Preoperative and postoperative measurements will be compared to evaluate the impact of surgery on these parameters.

Conclusion: Results will be analyzed and interpreted after data collection is completed, and conclusions will be drawn accordingly.

Study Timeline

• Study Start: 2022-02-15
• Primary Completion: 2023-04-15
• Study Completion: 2023-04-15
• Study First Submitted: 2024-03-26
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-11
• Last Update Submitted: 2024-04-11
• Study First Posted: 2024-04-16
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Data of patients aged 19-64 years
• Data of patients with BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 and at least one comorbidity such as obesity-related hypertension, dyslipidemia, type 2 diabetes mellitus, and sleep apnea
• Data of patients who underwent sleeve gastrectomy
• Volunteering

Exclusion Criteria

• Data of patients who were not deemed suitable for surgery by the physician and to whom a surgical technique different from sleeve gastrectomy was applied
• Data of patients who were not followed up by a dietitian for six months after surgery
• Data of patients with gastrointestinal inflammatory bowel disease
• Data of patients with psychiatric disorders diagnosed by a physician
• Data of patients with cancer, pregnant and lactating women, alcohol or drug addiction

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lipid Profile (Triglycerides, LDL, HDL)	Preoperative period, postoperative months 1 and 6	Milligrams per deciliter (mg/dL)
Body Weight	Preoperative period, postoperative months 1 and 6	Kilograms (kg)
BMI (Body Mass Index)	Preoperative period, postoperative months 1 and 6	Kilograms per square meter (kg/m2)
Lean Mass	Preoperative period, postoperative months 1 and 6	Kilograms (kg)
Fat Mass	Preoperative period, postoperative months 1 and 6	Kilograms (kg)
Fasting Blood Glucose	Preoperative period, postoperative months 1 and 6	Milligrams per deciliter (mg/dL)
Iron levels	Preoperative period, postoperative months 1 and 6	Micrograms per deciliter (µg/dL)
HbA1c	Preoperative period, postoperative months 1 and 6	Percentage (%)
Vitamin D level	Preoperative period, postoperative months 1 and 6	Nanograms per milliliter (ng/mL)

Trial Locations

Locations (1)

Ankara Yıldırım Beyazıt University; 🇹🇷 Ankara, Turkey